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PAS Team Abukhdeir, Amal Hani Acosta, Evelyn J Adkins, Sherry Ahmed, Sairah Amuzu, Rebecca A Becnel, Melody Cain, Taylor E Cummings, Justin Chen, Jessica Chihara, Dai Chin, Collin Daniel, Leena Davenport, Lavinne E Diaz,Felicia Delgado, Kristina DeMeza, Krystel G Do, Bryan Dsouza, Ly Fayad, Luis Flowers, Christopher Fowler, Nathan George, Shirley V Guerrero, Maria Gunter, Jillian Hagemeister, Fredrick Hernandez-Benson, Carlos Iyer, Swaminathan Jain, Preteesh James, Jinsu Johncy, Swapna Kalariya, Nilesh Kaufman, Greg Lai, Peter Le, Phat Lee, Hans Lee, Hun Lonon, Emily Lu, Rebecca Maiti, Abhishek Manasanch, Elisabet Marin, David Mistry, Haleigh Nair, Ranjit Nair, Sreekala Nastoupil, Loretta Neelapu, Sattva Nguyen, Minh-anh Nze, Chijioke Oriabure, Onyeka Orlowski, Robert Parmar, Simrit Patel, Krina Pulsifer, Brittani Rachel E,Leonard Rao, Ahalya Rankin, Kim Revilla, Maria Richards, Tiffany Rodriguez, Alma Saldana, Alexandra Shpall, Elizabeth Samaniego, Felipe Schmidt, Joo Singh, Prachee Steiner, Raphael Strati, Paolo Taylor, Erin Thomas, Sheeba Varghese, Jaimole Vo, Ann Wang, Michael Wang, Hongyan Watson, Grace Weber, Donna Weeks, Brittany Wesson, Emily Westin, Jason Zachariah, Annie Other
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Diagnosis at Presentation
Amyloidosis Burkitt Lymphoma Castlemans Disease Follicular Lymphoma Hodgkin Lymphoma Large B-Cell Lymphoma Mantle Cell Lymphoma Marginal Zone Lymphoma MGUS Multiple Myeloma Plasmacytoma SLL/CLL Lymphoma Smoldering Myeloma T-Cell Lymphoma Waldenstroms
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Clinical Trials Available
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RADONC / SCT Protocols
Additional criteria options are available below to narrow down available protocols
Today M-D-Y
Phase III, Randomized, Open-label, multicenter study evaluating efficacy and safety of mosunetuzumab in combination with lenalidomide in comparison to rituximab in combination with lenalidomide in patients with follicular lymphoma after at least one line of systemic therapy Protocol Number: 2021-0499 Slots available for FL: 12 Out of 15
Key Information:
Histologically documented CD20+FL Grades 1-3a. PI: Nastoupil, Loretta Contact: Caffey Frances Phone: 713-745-9910 Email: balaubacher@mdanderson.org
Protocol Key Eligibility Requirements for 2021-0499 Inclusion:
At least one bi-dimensionally measurable nodal lesion > 1.5 cm or at least one bi-dimensionally measurable extranodal lesion >1.0 cm. Requiring systemic therapy assed by investigator based on tumor size and/or GELF criteria. Pre-treatment sample of at least 1 core-needle, excisional or incisional tumor biopsy is required. Cytological or fine-needle aspiration samples are not acceptable.
Exclusion: History of transformation of indolent disease to DLBCL. Documented refractoriness to lenalidomide, defined as no response or relapse within 6 months of therapy. Prior standard or investigational anti-cancer therapy as specified below: Lenalidomide exposure within 12 mos prior to Day 1 of cycle 1, CAR-T therapy within 30 days prior to Day 1 of cycle 1, Radioimmunoconjugate within 12 weeks prior to Day 1 of cycle 1, Mab or antibody drug conjugate within 4 wks prior to Day 1 of cycle 1, Tx with any anti-cancer agent within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to Day 1 of cycle 1 Prior allo SCT. Live virus vaccine within 4 weeks prior to or during study therapy
Protocol Summary for 2021-0499
Protocol Abstract for 2021-0499
A Pilot, Single Arm, Single Center, Open Label Trial of Belantamab Mafodotin for the Treatment of High-Risk Smoldering Multiple Myeloma
Protocol Number: 2020-0431 Slots available for SMM: Key Information: CC>/=30; Plts>/=90; ANC>/= 1.0; Hgb>/= 2 gms below normal
PI: Manasanch, Elisabet Contact: Morphey. Ashley Phone: Pager:
Protocol Key Eligibility Requirements for: 2020-0431 Inclusion
Exclusion
A Pilot, Single Arm, Single Center, Open Label Trial of Belantamab Mafodotin for the Treatment of High-Risk Smoldering Multiple Myeloma
Protocol Number: 2020-0431 Slots available for SMM: Key Information:
PI: Manasanch, Elisabet Contact: Morphey. Ashley Phone: Pager:
A Phase 3 randomized, open label, multicenter study of isatuximab (SAR650984) in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone in patients with high-risk smoldering multiple myeloma
Protocol Number: 2020-1229 Slots available for SMM: Key Information:
PI: Manasanch, Elisabet Contact: Carpenter, Shawnee Email: SCarpenter@mdanderson.org Pager:
Protocol Key Eligibility Requirements for: 2020-1229 Inclusion
Exclusion
EAA173: Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM)
Protocol Number: 2021-0191 Slots available for SMM: Available Key Information:
DX within 12 months Hgb >/= 11 m spike >/= 1 PI: Manasanch, Elisabet Contact: Carpenter, Shawnee Phone: Pager:
Protocol Key Eligibility Requirements for: 2021-0191 Inclusion
Exclusion
Prospective observational study of clinical and genomic predictors of progression to myeloma in asymptomatic monoclonal gammopathies.
Protocol Number: PA15-0575 Slots available for MGUS: 26 out of 52
Key Information: PI: Manasanch, Elisabet
Contact: Huang, Mei
Phone: (713) 745-9901
Pager: (713) 404-0585
Protocol Key Eligibility Requirements for: PA15-0575 Inclusion Exclusion
Protocol Fact Sheet for: PA15-0575
Protocol Abstract for: PA15-0575
An Open-Label, Phase 2 Trial of Nanatinostat in Combination with Valganciclovir in Patients with Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas (NAVAL-1)
Protocol Number: 2021-0463 Slots available for Burkitt: 10 slots open Key Information:
1.EBV+ diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) 2. Extranodal NK/T-cell lymphoma (ENKTL) 3. Peripheral T-cell lymphoma (PTCL), including PTCL-NOS and angioimmunoblastic T-cell lymphoma (AITL): • 3a: Nanatinostat monotherapy • 3b: Nanatinostat + valganciclovir 4. Hodgkin lymphoma (HL) 5. Post-transplant lymphoproliferative disorder (PTLD) 6. Lymphomas associated with human immunodeficiency virus (HIV) infection (HIV-L): Plasmablastic, Burkitt, Hodgkin and DLBCL 7. EBV+ lymphomas other than the above PI: Nair, Ranjit Contact: Jenna Wixom Phone: (713) 416-3951
Protocol Key Eligibility Requirements for: 2021-0463
Protocol Abstract for 2021-0463
CPI-613 in R/R Burkitt Lymphoma/Leukemia or high-grade B-cell lymphoma with rearrangements of MYC and BCL2 and/or BCL6
Protocol Number: 2019-0605 Slots available for Burkitt:
Closed to enrollment d/t completion and memo submitted by sponsor
Key Information:
R/R Burkitt or R/R HGBCL double hit. Failure of one line is enough for Burkitt PI:
Steiner, Raphael
Contact:
Gallardo, Mariana
Phone:
(713) 792-9816
Protocol Key Eligibility Requirements for: 2019-0605
Inclusion: Histologic diagnosis of Burkitt's lymphoma/leukemia or HGBL with rearrangements of MYC and BCL2 and/or BCL6 confirmed Failure of at least one previous line of therapy or refusing treatment with standard therapy Failure after prior BM transplant, or ineligible for or opted not to participate in BM transplantation for Burkitt's lymphoma/leukemia. ECOG Status ≤ 3 Measurable disease as defined RECIL criteria (2017) or isolated bone marrow involvement Patients must have fully recovered from the acute, non-hematological, non- infectious toxicities of any prior treatment with anti-cancer drugs, radiotherapy or other anti-cancer modalities. Patients with persistent, non- hematologic, non-infectious toxicities from prior treatment must have documented resolution to ≤ Grade 2. Patients must have, or be willing and eligible to undergo placement of, a working central venous access device. Laboratory values obtained ≤ 2 weeks prior to enrollment must demonstrate adequate hepatic function, renal function, and coagulation as defined below:AST/SGOT ≤ 5x ULN ALT/SGPT ≤ 5x ULN Total bilirubin ≤1.5x ULN (unless related to hemolysis, Gilbert's syndrome, or involvement by lymphoma; if involvement by lymphoma: total bilirubin ≤ 3.0x ULN) Creatinine clearance >=40cc min either by 24-hour creatinine clearance or calculated from the modified Cockcroft-Gault equation INR must be ≤ 1.5. Due to the occurrence of thrombocytopenia, patients should not enter with coagulopathy. Patients on anticoagulants should be on short-acting therapy (e.g. low molecular weight heparin) rather than oral anticoagulants. Albumin ≥ 2.0g/dL (or ≥20g/L) Exclusion: Patients who have received a chemotherapy regimen with SCT in the previous 3 months Any medical condition that is clinically unstable despite present therapy Platelets < 50,000/mm3 unless attributable to marrow based (either Burkitt lymphoma or DHL/THL.) Note: Patients with leukemia/lymphoma in the marrow 25,000-50,000 will be assessed for grade 4 thrombocytopenia unless they have platelet recovery above grade 3. Patients entering with platelet will only be assessed for thrombocytopenia related to drug if they recover to grade 3 or higher Serious medical illness, such as significant cardiac disease (e.g. symptomatic congestive heart failure, unstable angina pectoris, coronary artery disease, myocardial infarction with the past 3 months, uncontrolled cardiac arrhythmia pericardial disease or NYHA Class III or IV), or severe debilitating pulmonary disease, that would potentially increase patient's risk for toxicity Patients with active CNS parenchymal disease. Patients with leptomeningeal disease are allowed as long as the CSF has cleared for more than 4 weeks and the patient is receiving maintenance intrathecal/intraOmmaya therapy. Any active uncontrolled bleeding or bleeding diathesis (e.g. active peptic ulcer disease) Any condition or abnormality which may, in the opinion of the investigator, compromise his or her safety Life expectancy less than 2 months (currently under review to remove or shorten expectancy) Patients with uncontrolled HIV infection defined as an HIV viral load > 100K and/or a documented opportunistic infection within the last 90 days AND no concurrent HIV therapy with zidovudine due to potential drug-drug interaction Patients who have received radiotherapy, surgery, treatment with cytotoxic agents, treatment with biologic agents, immunotherapy, or any other anti-cancer therapy for any kind for cancer, or any other investigational agent for any indication, within the past 2 weeks prior to initiation of CPI-613 treatment, with the exclusion of radiation to one area (eg. whole brain or involved nodal site) that does not interfere with response assessment in other sites. A course of steroids (up to 14 days total) prior to study initiation is acceptable. Psychiatric illness or social situation that would limit the patient's ability to tolerate and/or comply with study requirements. Prior allo SCT within 2 months of study start Patients with active GVHD are not eligible Patients receiving immunosuppressive therapy for prevention of GVHDe are not eligible
Protocol Fact Sheet for 2019-0605
Protocol Abstract for 2019-0605
Phase 2, Open-Label Randomized Study of Daratumumab, Carfilzomib, Lenalidomide,and Dexamethasone vs Carfilzomib, Lenalidomide,and Dexamethasone vs Bortezomib, Lenalidomide,and Dexamethasone in Patients with Newly-Diagnosed Multiple Myeloma (ADVANCE)
Protocol Number: 2021-0442 Slots available: Myeloma: Available
Key Information:
PI: Manasanch, Elisabet Contact: LLAdkins@mdanderson.org Phone: Pager:
Protocol Key Eligibility Requirements for 2021-0442 Inclusion:
A personalized vaccine for the immune prevention of multiple myeloma
Protocol Number: 2018-0345 Slots available: Please inquire for waitlist for 2020. Plan to re-open in first quarter of year per PI
Key Information:
CrCl Cutoff: >/= 40 ml/min Platelet Cutoff: >/=50,000 ANC>/= 1.0 Hgb >/= 10 PI: Manasanch, Elisabet Contact: Vora Amishi Email: AUVora@mdanderson.org
Protocol Key Eligibility Requirements for 2018-0345
Inclusion: Patients must have histologically confirmed SMM based on the following criteria. Both criteria must be met:Serum monoclonal protein (IgG or IgA) ≥ 3 g/dL or urinary monoclonal protein ≥ 500 mg per 24 hours and/or clonal bone marrow plasma cells more or equal to 10% Absence of myeloma defining events or amyloidosis Additionally, patients must meet criteria for intermediate or high risk of progression to multiple myeloma by PETHEMA criteria (patients must have at least 1 risk factors present): ≥95% abnormal plasma cells/total plasma cells in bone marrow compartment. Immunoparesis CrCl ≥ 40 ml/min using MDRD equation ECOG status 0-2 ANC ≥ 1.0 x 109 /L, hgb ≥ 10 g/dL and plts ≥ 50 x 109/L. Platelet and blood transfusions are allowed on protocol. Growth factors, including granulocyte colony stimulating factors and erythropoietin are allowed. Adequate hepatic function with bilirubin < 1.5 x the ULN, and AST and ALT < 3.0 x ULN. Exclusion: Evidence of myeloma defining events due to underlying plasma cell proliferative disorder meeting at least one of the followingHypercalcemia: serum calcium >0.25 mmol/L (>1 mg/dL) higher than the ULN or > 2.75 mmol/L (> 11 mg/dL) Cr Cl < 40 ml/min or serum Cr > 2 mg/dL hgb <10 g/dL Bone lesions: one or more osteolytic lesions on CT or PET-CT. Prior or concurrent systemic treatment for SMM.Bisphosphonates are permitted. Treatment with corticosteroids is not permitted (allowed for physiologic doses) Radiotherapy is not permitted. Prior treatment for SMM with chemo agents approved for the treatment of MM is not permitted. Plasma cell leukemia Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Has a known history of active TB Additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. Has a known history of HIV; Hep B or Hep C.
Protocol Abstract for 2018-0345
Protocol Fact Sheet for 2018-0345
Prospective observational study of clinical and genomic predictors of progression to myeloma in asymptomatic monoclonal gammopathies.
Protocol Number: PA15-0575 Slots available for SMM: 26 out of 52
Key Information: PI: Manasanch, Elisabet
Contact: Huang, Mei
Phone: (713) 745-9901
Pager: (713) 404-0585
Protocol Key Eligibility Requirements for: PA15-0575 Inclusion Exclusion
Protocol Fact Sheet for: PA15-0575
Protocol Abstract for: PA15-0575
An Open-Label, Multicenter, Phase 2 Study of CLR 131 in Patients with Relapsed or Refractory (R/R) Select B-Cell Malignancies (CLOVER-1) and Expansion Cohort in Patients with Waldenstrom Macroglobulinemia (CLOVER-WaM)
Protocol Number: 2021-0647 Slots available for Waldenstroms: Available
Key Information:
Plasma Cell Dyscrasias (Waldenstroms, Multiple Myeloma, MGUS, Smoldering Myeloma) eGFR>/= 30 PI: Thomas, Sheeba Contact: Morphey, Ashley Phone: (713) 792-8785 Email: JSGeorge4@mdanderson.org
Protocol Key Eligibility Requirements for 2021-0647
Apg-2575WU101
Protocol Number: 2020-0534 Slots available for Waldenstroms: Available
Key Information:
Cohort B (untreated) - waitlist Cohort A ( 1 prior line, must have failed or intolerant to ibrutinib or other BTK inhibitor) - available Cohort C (1 prior line, naive to BTK inhibitor) - available ANC>/= 1.0; Plts>/=75; eGFR>30; PI: Thomas, Sheeba Contact: Wishkoski, Krystal Email: KLWishkoski@mdanderson.org
Protocol Key Eligibility Requirements for 2020-0534
A Phase 1, First-in-Human, Dose Escalation Study of the JNJ-75348780 Bispecific Antibody Targeting CD3 and CD22 in Participants with NHL and CLL
Protocol Number: 2021-0203 Slots available for Waldenstroms: 0 OUT OF 10 Key Information: Patients with R/R B-cell NHL DLBCL: received or not eligible for high-dose chemotherapy and autologous stem cell transplantation with curative intent. FL/MZL (except MALT) or WM: Previously treated with at least 2 prior line of systemic therapy, with at least one prior line containing an anti-CD20 antibody. MCL: Previously treated with at least 1 prior line of systemic therapy containing an anti-CD20 antibody. Patients with CLL or SLL: R/R with at least 2 prior line of systemic therapy containing a BTK inhibitor and/or a BCL2 inhibitor, if eligible. ECOG 0-1 Adequate lab parameters without transfusion for at least 7 days prior to first dose of study drug
PI: Chihara, Dai Contact: Amanda Nunmaker Phone: 346-725-2997 Email: AMnunmaker@mdanderson.org
A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis
Protocol Number: 2020-0464 Slots available for Amyloidosis: available
Key Information:
Advanced cardiac involvement NT proBNP >8500 no concurrent mm Troponin T >0.035 PI: Lee, Hans Contact: Wishkoski, Krystal Email: KLWishkoski@mdanderson.org
Protocol Key Eligibility Requirements for 2020-0464 Inclusion:
A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIa AL Amyloidosis
Protocol Number: 2020-0472 Slots available for Amyloidosis: available
Key Information:
advanced cardiac involvement NT proBNP >650 and <8500 Troponin T >0.035 no concurrent mm PI: Lee, Hans Contact: Wishkoski, Krystal Email: KLWishkoski@mdanderson.org
Protocol Key Eligibility Requirements for 2020-0472 Inclusion:
A Phase 2 Study of Daratumumab, Bortezomab and Dexamethasone followed by Daratumumab, Ixaazomib, and Dexamethasone for Relapsed/Refractory Myeloma
Protocol Number: 2018-0512 Slots available: 10 out of 60
Key Information: < 3 Prior Lines
CrCl Cutoff: >/= 30 mL/min/1.73 m² Platelet Cutoff: >=75 ANC>/= 1.0 PI: Lee, Hans Contact: Murga Astrid Phone: ADMurga@mdanderson.org Pager: (713) 606-3750
Protocol Key Eligibility Requirements for: 2018-0512
Inclusion: Dx of MM Measurable disease:Serum M-protein level >/= 0.5 g/dL Urine M-protein excretion of >/=200 mg over a 24-hour period sFLC I:U >/=10 mg/dL, along with an abnormal sFLC ratio R/R after their most recent therapy, with PD defined as increase of 25% from the lowest response in any one or more of the following:Serum M-component protein (the absolute increase must be >/=0.5 g/dL) Urine M-component protein (the absolute increase must be >/=200 mg/24 hours) Only in subjects without a measurable serum and urine M protein level: FLC levels (absolute increase) must be >10 mg/dL new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to the plasma cell proliferative disorder. 1 to 3 lines of therapy PR or better to at least one prior line of therapy Labs: ANC >/=1,000 without growth factors within 2 week of initiation of treatment b. Plt >=75 c. Tbili < /= 1.5 × ULN. In subjects with documents Gilbert's syndrome, total bilirubin < /= 2 × ULN. d. AST/ ALT < /= 3 × ULN e. Cr cl >/= 30 mL/min/1.73 m² Exclusion: Received prior ixazomib at any time or daratumumab or other anti-CD38 therapies, except as part of initial therapy if this was stopped to move on to SCT and the subject did not progress on anti-CD38 treatment. Refractory to bortezomib or carfilzomib (defined as PD while on bortezomib or carfilzomib therapy or within 60 days after ending bortezomib or carfilzomib therapy). Known COPD with a FEV1 < 50% of predicted normal. Previously participated in a study with ixazomib whether treated with ixazomib or not.
Protocol Fact Sheet for 2018-0512
Protocol Abstract for 2018-0512
Phase 1/2 FIH Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) in Patients with Relapsed or Refractory Multiple Myeloma
Protocol Number: 2020-1124 Slots available Myeloma:
Key Information:
No prior BCMA CART Does allow prior BCMA 4 week w/o Dara if no M protein can be IgA>/= to 400; Plts>50K; anc>1; hGb>8.0;cc>30 PI: Lee, Hans Contact: Navarrete, Kim Email: KHThan@mdanderson.org
Protocol Key Eligibility Requirements for: 2020-1124
A Single-arm, Open-label, Phase 1/2 study evaluating the safety, efficacy, and cellular kinetics/pharmacodynamics of Allo-647 and Allo-605, an anti-bcma allogeneic car t cell therapy in patients with relapsed/refractory multiple myeloma
Protocol Number: 2021-0513 Slots available for MM:
Key Information:
ANC>/=1.0; Plts>/=50; Hgb>/=8; Hgb>/=8; CC or eGFR>/= 60; EF>/= 50; PI: Patel, Krina Contact: Email: MIGray@mdanderson.org
Protocol Key Eligibility Requirements for: 2021-0513
A Phase 1/2a, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HDP-101 in Patients with Plasma Cell Disorders Including Multiple Myeloma
Protocol Number: 2021-0185 Slots available for MM:
Key Information:
ANC>/= 1.0; Plts >/=75; Hgb>/=75; Hgb>8; CC>/=60 PI: Orlowski, Robert Contact: Wishkoski, Krystal Email: KLWishkoski@mdanderson.org
Protocol Key Eligibility Requirements for: 2021-0185
An Open-Label, Multicenter, Phase I Trial Evaluating the Safety and Pharmacokinetics of Escalating Doses of Bfcr4350a in Patients with Relapsed or Refractory Multiple Myeloma
Protocol Number: 2020-0103 Slots available for MM: no slots. waitlist. expansion cohort planned to open in a couple months
Key Information:
Plts>/=50; ANC>/=1000; Hgb >/=8; Creatinine< /= 2; CC >/=30 PI: Thomas, Sheeba Contact: Email: MIGray@mdanderson.org
Protocol Key Eligibility Requirements for: 2020-0103
Protocol Key Eligibility Requirements for: 2019-0499
A PHASE 1/2, MULTICENTER, OPEN-LABEL, STUDY TO DETERMINE THE Recommended Dose and Regimen and evaluate the safety and efficacy of CC-92480 in combination with Standard Treatment in Subjects with Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)
Protocol Number: 2019-0452 Slots available for SMM: Available Key Information:
DCC.45; Prior BCMA allowed PI: Kaufman, Greg Contact: Miller, Carla Phone: KLWishkoski@mdanderson.org Pager:
Protocol Key Eligibility Requirements for: 2019-0452 Inclusion
Exclusion
A Randomized Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Patients with NDMM Who Are MRD Positive After Frontline ASCT
Protocol Number: 2019-0304 Slots available for MM: Maintenance only Key Information:
18-79 years old minimum of 4 cycles of induction therapy must be within 12 months of start of induction 6 months from ASCT Must have achieved a VGPR or better MRD positive PI: Becnel, Melody Contact: Wishkoshi, Krystal Email: KLWishkoski@mdanderson.org
Protocol Key Eligibility Requirements for: 2019-0304 Inclusion: NDMM with a history of 4 to 8 total cycles of induction with or without consolidation therapy and have received HDT and ASCT. For patients who have not received consolidation therapy, the patient must be 60 to 100 days post-transplant at the time of randomization. For patients treated with consolidation therapy, the patient must be within 60 days of the last dose of consolidation therapy at the time of randomization. Must have a VGPR or better response assessed per IMWG 2016 criteria at the time of
randomization. Have archived BMx samples collected before induction treatment or before transplant. Archived bone marrow samples will be used for calibration of myeloma clonal cells to facilitate assessment of primary end point by NGS. Any one of the following archived samples are required:Greater than 1 mL viable frozen bone marrow aspirated aliquot (preferred) collected in an EDTA tube, frozen, and stored at a temperature of −80°C, or Non-decalcified diagnostic bone marrow tissue for MRD assessment:5 slides, 5 m each, of non-decalcified bone marrow, or 5 slides, 5 m each, bone marrow aspirate smear Must have residual disease as defined by detectable MRD by NGF assay. Must have an ECOG status of 0, 1, or 2. Must have pretreatment clinical laboratory values meeting the following criteria during screening (laboratory tests should be repeated if not done within 3 days of C1D1): Adequate bone marrow function:Hemoglobin ≥7.5 g/dL (≥4.65 mmol/L). Prior RBC transfusion or recombinant human erythropoietin use is permitted, however transfusions are not permitted within 7 days of randomization to achieve this minimum hemoglobin count. Absolute neutrophil count ≥1.0×109/L. Granulocyte colony stimulating factor use is permitted. Platelet count 50×109/L. Adequate liver function: Aspartate aminotransferase ≤2.5 folds of the ULN. Alanine aminotransferase ≤2.5 folds of the ULN. Total bilirubin ≤1.5 folds of the ULN (except in patients with congenital bilirubinemia, such as Gilbert syndrome, direct bilirubin ≤1.5 folds of the ULN).
Adequate renal function: a. Estimated creatinine clearance ≥30 mL/min. Creatinine clearance may be calculated using Cockcroft-Gault, estimated glomerular filtration rate [MDRD], or CKD-EPI formula Corrected serum calcium ≤13.5 mg/dL (≤3.4 mmol/L) or free ionized calcium ≤6.5 mg/dL (≤1.6 mmol/L) Exclusion: Have peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the NCI-CTCAEv5 Have any prior or concurrent invasive malignancy within 5 years of date of randomization (exceptions are adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion that in the opinion of the investigator, and concurrence by the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years). Have had prior treatment/therapy with:Anti-CD38 antibody at any time, Radiation within 14 days of randomization, or Plasmapheresis within 28 days of randomization. Be exhibiting clinical signs of meningeal or central nervous system involvement due to MM. Have known COPD with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal. Note that FEV1 testing is required for patients with suspected COPD or asthma. Patients with FEV1 <50% of predicted normal (or for patients ≥65 years of age, old FEV1 <50% or DLCO <50%) on screening assessment must be excluded. Have known moderate or severe persistent asthma within the past 2 years, or current uncontrolled asthma of any classification. Note that patients who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study, provided that FEV1 is ≥50% of predicted normal. Have any of the following: Seropositive for HIV Seropositive for hepatitis B [HBsAg]. Subjects with resolved infection (ie, subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to anti-HBs) must be screened using real-time (PCR measurement of HBV DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR. Seropositive for hepatitis C (anti- hepatitis C virus [HCV] antibody positive or HCVRNA quantitation positive), except in the setting of a sustained virologic response, defined as aviremia at least 12 weeks after completion of antiviral therapy). Have a concurrent medical or psychiatric condition or disease (eg, active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study. Have any of the following:Myocardial infarction within 6 months of randomization, or an unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina, congestive
heart failure, New York Heart Association Class III-IV), Uncontrolled cardiac arrhythmia (NCI-CTCAE Version 5 Grade ≥2) or clinically significant ECG abnormalities, Screening 12-lead ECG showing a baseline QT interval >470 msec, For patients aged 65 to 79 years, a left ventricular ejection fraction of <40% Have known allergies, hypersensitivity, or intolerance to boron or mannitol, corticosteroids, mAbs or human proteins, or their excipients (refer to the Investigator's Brochure) or known
sensitivity to mammalian-derived products or lenalidomide. Be known or suspected of not being able to comply with the study protocol (eg, because of alcoholism, drug dependency, or psychological disorder). Have any condition for which, in the opinion of the investigator, participation would not be
in the best interest of the patient (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. Have had major surgery within 2 weeks before randomization or will not have fully recovered from surgery, or has surgery planned during the time the patient is expected to
participate in the study; kyphoplasty or vertebroplasty is not considered major surgery. Have received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before randomization or is currently enrolled in an interventional investigational study. Have contraindications to the use of lenalidomide or daratumumab, per local prescribing information. Have gastrointestinal disease that may significantly alter the absorption of oral drugs. Have received vaccination with live attenuated vaccines within 4 weeks of first study agent administration Be unable or unwilling to undergo antithrombotic prophylactic treatment.
Protocol Fact Sheet for 2019-0304
A Phase 1 Dose-Escalation and Exploratory Dose Expansion Study of AMG 232 in Combination with Carfilzomib, Lenalidomide, and Dexamethasone in RRMM
Protocol Number: NCI10076 Slots available for MM:
3 out of 3 Key Information:
CrCl Cutoff: >/= 50 mL/min Platelet Cutoff: >/= 50,000 uL (>/= 30,000uL if BMPC >/= 50%) PI:
Lee, Hans
Contact:
Lu, Rebecca
Phone:
(713) 294-1119
Pager:
(713) 404-4552
Protocol Key Eligibility Requirements for NCI10076
Inclusion: Measurable disease, as defined by at least one of the following:Serum monoclonal protein M-protein level ≥0.5 g/dL Urinary M-protein excretion of ≥200 mg over a 24-hour period sFLC I:U ≥10 mg/dL, along with an abnormal free light chain ratio R/R after their most recent therapy, with PD being defined as an increase of 25% from the lowest response value in any one or more of the following: Serum M-component protein (the absolute increase must be ≥0.5 g/dL) and/or Urine M-component protein (the absolute increase must be ≥200 mg/24 hours) and/or Only in subjects without a measurable serum and urine M protein level: the difference between I:U sFLC levels must be >10 mg/dL d. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to the plasma cell proliferative disorder. Subjects with one to three lines of therapy for their disease, with a line of therapy defined as one or more cycles of a planned treatment program. Completed their most recent drug therapy directed at MM in the following timeframes: Antitumor therapy at least 21 days prior to C1D1 AMG 232 + KRd. Corticosteroids at least 3 weeks prior to starting AMG 232 + KRd, except for a dose equivalent to dex of ≤4 mg/day AutoSCT at least 12 weeks prior to starting AMG 232 + KRd AlloSCT at least 24 weeks prior to starting AMG 232 + KRd, and these subjects must also NOT have moderate to severe active acute or GVHD. Subjects must have ECOG status ≤ 2 (Karnofsky ≥ 60%). LABS: ANC ≥ 1,000/mcL without growth factors; Platelets ≥50,000 cells/mm3 if marrow plasmacytosis < 50% OR platelet count ≥30,000 cells/mm3 if marrow plasmacytosis ≥ 50%.; Hemoglobin ≥8 g/dL; Total bilirubin < 1.5 × institutional ULN (< 2.0 × ULN for subjects with documented Gilbert's syndrome or < 3.0 × ULN for subjects for whom the indirect bilirubin level suggests an extrahepatic source of elevation); AST(SGOT)/ALT(SGPT) ≤ 2.5 × ULN; ALK < 2.0 × ULN (if liver or bone disease are present, < 3.0 × ULN); CrCl ≥ 50 mL/min/1.73 m²; PT or (PTT < 1.5 × ULN, OR INR < 1.5 Radiation therapy targeting > 10% of the bone marrow space must have completed this at least 2 weeks prior to starting therapy with AMG 232 + KRd. Life expectancy of at least 3 months. Exclusion: R/R to KRd when used in combination defined as progression of disease while on therapy or within 60 days of completing therapy. Evidence of WT p53 status on somatic tissue specimens as assessed by DNA sequencing. Not recovered from toxicities from prior anti-tumor therapy Receiving any other investigational agents. Major surgery within 28 days of study day 1. Vertebroplasty and/or kyphoplasty, which must have been performed at least 1 week prior to starting AMG 232 + KRd CNS involvement of myeloma History of allergic reactions attributed to compounds of similar chemical or biologic composition to AMG 232 or carfilzomib, lenalidomide, or dexamethasone. Medication list such a herbal medicines (e.g., St. John's wort), vitamins, and supplements will be reviewed before starting first dose of AMG 232 and at each clinic visit. Treatment with medications known to cause QTc interval prolongation within 7 days of study day 1 unless is not permitted unless approved by the sponsor. Use of ondansetron is permitted for treatment of nausea and vomiting. Current use of warfarin, factor Xa inhibitors and direct thrombin inhibitors. Subjects taking warfarin must have their INR followed closely. Uncontrolled intercurrent illness including History of bleeding diathesis. Active infection requiring IV antibiotics within 2 weeks of study enrollment Positive HepBsAg, Hepatitis total core antibody with negative HBsAG or detectable Hepatitis C virus RNA by a PCR assay. Subjects with hepatitis B virus suppressed on therapy, and previously treated/eradicated hepatitis C virus are eligible. HIV are NOT excluded from this study, but HIV-positive subjects must have: A stable regimen of HAART No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections. A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR-based test Subjects with prior treatment with an MDM2 inhibitor.
Protocol Fact Sheet for NCI10076
Protocol Abstract for NCI10076
A Phase 1/2 FIH Study of REGN5459 (Anti-BCMA x Anti CD3 Bispecific Antibody) in Patients with R/RMM Protocol Number: 2019-0945 Slots available for MM:
Pending activation, building waitlist; 1 open slot
Key Information:
CrCl Cutoff: Platelet Cutoff: PI:
Lee, Hans
Contact:
Lu, Rebecca
Phone:
(713) 294-1119
Pager:
(713) 404-4552
Protocol Key Eligibility Requirements for: 2019-0945
Inclusion ECOG status ≤1 Confirmed active MM by IMWG Patients must have symptomatic myeloma at the time of study entry with myeloma related organ damage or tissue dysfunction Patients must have myeloma that is measurable by either serum or urine FLC Measurable disease is defined as 1 or more of the following:Serum M-protein ≥1 g/dL Urine M-protein ≥200 mg/24-hour, and/or FLC assay with i:u FLC level ≥10 mg/dL with an abnormal sFLC ratio A patient with IgA MM but without measurable Mprotein may be enrolled if quantitative IgA levels are elevated and can be followed longitudinally A patient with non-secretory MM may be considered for enrollment after discussion with the sponsor that includes the feasibility of an individualized plan for response assessment. Disease progression based on IMWG criteria Patients with MM who have exhausted all therapeutic options that are expected to provide meaningful clinical benefit, either through disease relapse, treatment refractory disease, or intolerance or refusal of the therapy, and including either: Progression on or after at least 3 lines of therapy, or intolerance of therapy, including proteasome inhibitor, an IMiD, and an anti-CD38 antibody, OR Progression on or after an anti-CD38 antibody and have disease that is "double refractory" to a proteasome inhibitor and an IMiD, or intolerance of therapy. The anti-CD38 antibody may have been administered alone or in combination with another agent such as a proteasome inhibitor. Refractory disease is defined as lack of response or relapse within 60 days of last treatment. LABS: Platelet count > 50 x 109/L. A patient may not have received a platelet transfusion within 7 days in order to meet this platelet eligibility requirement. ANC > 1.0 x 109/L. A patient may not have received G-CSF within 2 days in order to meet this ANC eligibility requirement. Hemoglobin > 8.0 g/dL Adequate hepatic function, defined as: Total bilirubin ≤1.5 x ULN; ALT, AST ≤2.5 x ULN; ALK ≤2.5 x ULN, Patients with Gilbert syndrome do not need to meet this total bilirubin requirement provided that the total bilirubin is unchanged from the baseline value. Serum Cr by Cockcroft-Gault >30 mL/min A patient with a creatinine clearance by Cockcroft-Gault who does not meet eligibility criteria may be considered for enrollment if a measured CR (based on 24-hour urine collection or other reliable method) is >30 mL/min. If previously treated with CAR T therapy or any gene therapy products, patients must have recovered from the toxicities of this therapy Life expectancy of at least 6 months Exclusion Presence of PCL, WM (LL), or POEMS Known MM brain lesions or meningeal involvement with MM CNS myeloma should be excluded by radiographic imaging and/or lumbar puncture, as appropriate History of neurodegenerative condition or CNS movement disorder Cardiac ejection fraction < 40% by echocardiogram or MUGA Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent within 72 hours of start of study drug Vaccination within 28 days prior to first study drug administration with a vector that has replicative potential Treatment with any systemic standard or investigational anti-myeloma therapy within 5 half-lives or within 28 days prior to first administration of study drug, whichever is shorter Prior treatment with any anti-BCMA antibody (including antibody-drug conjugate or bispecific antibody) or BCMA-directed CAR T therapy Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first administration of study drug Uncontrolled infection with HIV, HBV or HCV infection; or other uncontrolled infection a. Patients with HIV who have controlled infection (undetectable viral load and CD4 count above 350 cells/microliter either spontaneously or on a stable antiviral regimen) are permitted. b. Patients with positive HepBsAg+ who have controlled infection serum HBV DNA PCR that is below the limit of detection AND receiving anti-viral therapy for hep B are permitted. Patients who are HCV Ab+ who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted. History of documented severe allergic reactions or acute hypersensitivity reaction attributed to prior antibody treatments A severe allergic reaction is defined for this purpose as that which has met criteria for CTCAE v5.0 grade 3 or grade 4 severity History of hypersensitivity to any compound in the tetracycline antibiotics group Known hypersensitivity to both allopurinol and rasburicase History of allo SCT at any time, or auto SCT within 12 weeks of the start of study treatment Member of the clinical site study team or his/her immediate family, unless prior approval granted by the sponsor
Protocol Fact Sheet for 2019-0945
Protocol Abstract for 2019-0945 Phase I, open label dose-escalation study to evaluate the safety, expansion, persistence and clinical activity of a single dose of UCARTCS1 (antigen receptor) in patients with RRMM
Protocol Number: 2017-0494 Slots available for MM:
HOLD; 2 out of 2 filled Key Information:
CrCl Cutoff: >/= 60 mL/min Platelet Cutoff: >/= 50,000 uL (>/= 30,000 uL if BMPC >/= 50%) PI:
Patel, Krina
Contact:
Lu, Rebecca
Phone:
(713) 294-1119
Pager:
(713) 404-4552
Protocol Key Eligibility Requirements for: 2017-0494
Inclusion: measurable disease, defined by at least one of the following:Serum monoclonal protein ≥0.5 g/dL; Monoclonal protein in the urine on 24-hour electrophoresis ≥200 mg; Serum immunoglobulin free light chain (FLC) ≥10 mg/dL provided serum FLC ratio is abnorma; Measurable plasmacytoma on exam or imaging; or e. Bone marrow plasma cells ≥20% ECOG Status of 0 or 1 Estimated life expectancy >12 weeks LABS:ANC ≥1,000/μL;Platelet count ≥50,000/μL, (≥30,000/μL if bone marrow plasma cells are ≥50% ofcellularity);Hemoglobin >8g/dL;CrCL ≥60 mL/min; AST/ALT < 3 x ULN; Total bilirubin < 2 x ULN; LVEF ≥50% as assessed by MUGA; and a minimum level of pulmonary reserve defined as Grade < 2 dyspnoea and pulse oxygenation ≥92% on room air Toxicities from prior therapies, with the exception of peripheral neuropathy attributable to bortezomib, must have recovered to Grade ≤2 according to the CTCAE v5.0 criteria Exclusion: Previous treatment with investigational gene targeting CS1 or chimeric antigen receptor
therapy targeting CS1; Prior treatment with a CS1-directed monoclonal antibody within 3 months before enrollment Previous chemotherapy or biologic targeted therapy or immunological agents within 14 days prior to enrollment. Radioimmunotherapy or radiotherapy, within 8 weeks (except for palliative radiotherapy at localized lesions not considered as target lesion) Use of other investigational products within 5 half-lives or within 28 days prior to
UCARTCS1A administration. PCL, WM's, AL, POEMs AutoSCT within 12 weeks prior to enrollment Any cellular therapy (other than autologous or allogenic HSCT) within 60 days prior to enrollment Prior alloSCT Use of rituximab and other anti-CD20 antibodies known to have the same epitope as rituximab or anti-CD20 for which the epitope is unknown within 3 months prior to enrollment Active immunosuppressive agents that cannot be stopped Patients may not receive ≥20 mg of prednisone or equivalent between Day -7 and Day 28 of UCARTCS1A administration unless required for toxicity management. Known HIV or T-cell leukemia/lymphoma
virus type 1 Seropositive for Hepatitis C virus or positive for Hepatitis B surface antigen or core antibody HHV7 negative patients are excluded from receiving IMP batches with detectable titer ofHHV7 (as assessed by RT-PCR Assay) Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management; simple urinary tract infection and uncomplicated bacterialpharyngitis are permitted Known hypersensitivity to any of the test materials or related compounds including murine and bovine products Uncontrolled hypertension (systolic blood pressure [BP] >150 mmHg and/or diastolic BP >100 mmHg), unstable angina, congestive heart failure (New York Heart Association >1), serious cardiac arrhythmia that requires treatment with the exceptions of atrial fibrillation and paroxysmal supraventricular tachycardia and history of myocardial infarction within 6 months of enrollment Presence of active and clinically relevant CNS disorder, such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injury, dementia,Parkinson's disease, cerebellar disease, or organic brain syndrome History of hypertension crisis or hypertensive encephalopathy within 3 months prior to Screening
Protocol Fact Sheet for 2017-0494
Protocol Abstract for 2017-0494 An Exploratory Phase 1/2 Trial to Determine Recommended Phase 2 Dose (RP2D), Safety and Preliminary Efficacy of BB2121 (IDE-CEL) Combinations in Subjects with Relapsed/Refractory Multiple Myeloma
Protocol Number: 2020-0934 Slots available for MM:
Key Information:
Hgb>8; EF>/=45; Plts 75-100; ANC 1.0-1.5; CC>45->60; ECOG 0-1 PI: Patel, Krina Contact: Nilesh, Kalariya Phone: (832) 728-3304 Pager: (713) 404-9378
Protocol Key Eligibility Requirements for: 2020-0934
A Phase 1, First-in-Human, Dose Escalation Study of the JNJ-75348780 Bispecific Antibody Targeting CD3 and CD22 in Participants with NHL and CLL
Protocol Number: 2021-0203 Slots available for MCL: 0 OUT OF 10 Key Information:MCL: Patients with R/R B-cell NHL MCL: Previously treated with at least 1 prior line of systemic therapy containing an anti-CD20 antibody. ECOG 0-1 Adequate lab parameters without transfusion for at least 7 days prior to first dose of study drug
PI: Chihara, Dai Contact: Amanda Nunmaker Phone: 346-725-2997 Email: AMnunmaker@mdanderson.org
Protocol Key Eligibility Requirements for: 2021-0203
Protocol Fact Sheet for: 2021-0203 A Phase I/II Open Label, Single Center, Study of the Combination of ALX148, Rituximab and Lenalidomide in Patients with Indolent and Aggressive B-cell Non-Hodgkin Lymphoma
Protocol Number: 2021-0226 Slots available for MCL: 0 OUT OF 24 Phase II is open
Key Information: Phase II: Frontline treatment of indolent B-NHL; no prior systemic treatment, high tumor burden disease, Stage III or IV, ECOG 0-1Phase II: Frontline treatment of indolent B-NHL; no prior systemic treatment, high tumor burden disease, Stage III or IV, ECOG 0-1
PI: Strati, Paolo Contact: Davidson, Jeffry Phone: (713) 745-5095 Pager:
Protocol Key Eligibility Requirements for: 2021-0226
Protocol Fact Sheet for: 2021-0226
A Phase 1/2, First in Human, Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Triple-specific T-cell Engager 1A46 in Adult Patients with Advanced CD20 and/or CD19 Positive B-cell Hematologic Malignancies
Protocol Number: 2021-1214 Slots available for MCL: 1 out of 1
Key Information:
1A46 is a tri-specific T-cell activating antibody that binds to human CD3, CD19 and CD20. Infusions are weekly for the first 8 cycles (24 weeks) and then once q3 weeks for the next 8 cycles. Patients will be hospitalized for 72 hours following each new dose level (3 total dose levels); subsequent doses may be outpatient. Trial is in dose escalation phase. PI: Ahmed, Sairah Contact: lcebarle@mdanderson.org Phone:
Protocol Fact Sheet for 2021-1214
A Phase 1, Multicenter, Open-Label Study of CB-010, a CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy in Patients with Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma Protocol Number: 2020-1041
Slots available for MCL:
5 OUT OF 5
Key Information:
Phase 1 study of CB-010, a CRISPR-edited allogeneic anti-CD19 CAR-T cell therapy in R/R B-cell NHL (DLBCL, tFL, PMBCL, HGBCL, MCL, FL, and MZL) PI:
Nastoupil, Loretta
Contact:
Dsouza, Ly
Phone:
832-817-8154
Protocol Eligibility Requirements for 2020-1041
Inclusion: DLBCL, HGBL, tFL, PMBCL Prior therapy must include anti-CD20 Ab and anthracycline and 1 or more of the following: Primary refractory diseaseNo response to second or more lines of therapy Refractory post ASCT FL or MZL Failed an anti-CD20 Ab and alkylating agent Best response to most recent therapy was PD MCL Failed anti-CD20 Ab, alkylating agent, and BTKi ECOG of 0 or 1 Oxygen saturation > 92% on room air with ≤ Grade 1 dyspnea Cardiac ejection fraction > 50% and no evidence of pericardial effusion or clinically significant ECG findings Laboratory parameters as follows: Serum albumin ≥ 3.0 g/dL; ALT/AST ≤ 2.5 × ULN; ANC ≥ 1000/uL; Platelet count ≥ 75,000/uL; Serum creatinine ≤ 1.5 × ULN, or calculated creatine clearance > 60 mL/min by Cockcroft Gault formula or estimated glomerular filtration rate > 60 mL/min/1.73 m2; Total bilirubin ≤ 1.5 mg/dL
Exclusion: History of prior therapy with an anti-CD19 targeting agent Active acute or chronic GvHD requiring therapy History of allogeneic stem cell transplantation ASCT within 8 weeks of informed consent Clinically significant CNS dysfunction or disease. Current thyroid disorder (including hyperthyroidism). Hypothyroidism controlled with a stable dose of hormone replacement therapy is permitted History of HIV. Active hepatitis B or C virus infection. Requirement for urgent therapy because of tumor mass effects such as bowel obstruction or blood vessel compression Presence of pleural, peritoneal or pericardial catheter Clinically significant pleural effusion History of significant cardiac disease within 12 months of enrollment Concurrent or previous other malignancy within 2 years of study entry, except curatively treated malignancies. History of autoimmune disease resulting in end organ injury or requiring within the last 2 years systemic immunosuppressive or disease modifying agents
Protocol Summary for 2020-1041
Juno Therapeutics Protocol Number: 2015-0529 Slots available for MCL:
10 OUT OF 10 Key Information:
PI:
Wang, Michael
Contact:
Nava, Diana
Phone:
(713) 792-4255
Pager:
(713) 404-2892
Protocol Eligibility Requirements for 2015-0529
Inclusion:
Rel/ref B-cell NHL of the following histologies: a. DLBCL cohort: DLBCL, includes transformed DLBCL from indolent histology [tDLBCL]), high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology, PMBCL, and FL gr 3B. Subjects must have been treated with an anthracycline and rituximab and have R/R after at least 2 lines of therapy or auto-HSCT. MCL cohort: MCL with cyclin D1 expression or t(11;14) by CG, FISH, or PCR] with R/R after at least 1 prior line of MCL therapy PET-positive disease according to Lugano Classification Archived tumor biopsy tissue available from the last relapse or, if at least one tumor-involved site is deemed accessible at time of screening, willing to undergo pre-treatment biopsy (excisional when possible) for disease confirmation. If the subject has never had a CR, a sample from the most recent biopsy is acceptable LABS: Serum Cr < /=1.5 x ULN or CrCl >30mL/min/1.73m^2; * ALT < /=5 x ULN and Tbili < 2.0 mg/dL (or < 3.0 mg/dL for subjects with Gilbert's syndrome or lymphomatous infiltration of the liver); < /= CTCAE Grade 1 dyspnea and oxygen saturation (SaO2) >/=92% on room air; LVEF >/=40% as assessed by Echo or MUGA Adequate vascular access for leukapheresis procedure (either peripheral line or surgically-placed line) Subjects who have received previous CD19-targeted therapy must have CD19-positive lymphoma confirmed on a biopsy since completing the prior CD19-targeted therapy Exclusion:
CNS only involvement by malignancy. (note: subjects with secondary CNS involvement are allowed on study) Treatment with alemtuzumab within 6 months of leukapheresis, or treatment with fludarabine or cladribine within 3 months of leukapheresis Active hep B, C, or HIV infection at the time of screening Presence of acute or chronic GVHD Prior CAR T-cell or other genetically-modified T-cell therapy, with the exception of prior JCAR017 treatment in this protocol for subjects receiving retreatment
Protocol Summary for 2015-0529
Protocol Abstract for 2015-0529
A Phase 1, First-in-Human, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-67856633, an Inhibitor of MALT1, in Participants With NHL and CLL
Protocol Number: 2020-0452 Slots available for MCL: 15 OUT OF 15 CNPE
Protocol is terminated.
Key Information:
ECOG of 0-1 Labs: Hgb ≥8 g/dL, Plt ≥75×109/L, ANC ≥1.0×109/L, AST, ALT, GGT, and alkaline phosphatase ≤2.5× ULN, Serum total bilirubin ≤1.5× ULN, calculated or measured creatinine clearance ≥40 mL/min. Exclusion: Known active CNS involvement, prior solid organ transplant, active autoimmune disease requiring systemic immunosuppressive meds and active or chronic Hep B, C, HIV infection. PI: Samaniego, Felipe Contact: jennramos@mdanderson.org Phone: 713-563-5426
Protocol Eligibility Requirements for 2020-0452 Inclusion: ECOG of 0-1 Hgb ≥8 g/dL, Plt ≥75×109/L, ANC ≥1.0×109/L, AST, ALT, GGT, and alkaline phosphatase ≤2.5× ULN, Serum total bilirubin ≤1.5× ULN, calculated or measured creatinine clearance ≥40 mL/min. Exclusion: Known active CNS involvement prior solid organ transplant active autoimmune disease requiring systemic immunosuppressive meds active or chronic Hep B, C, HIV infection
Protocol Summary for 2020-0452
View more available MCL protocols?
Yes
venetoclax and acalabrutinib treated r/rMCL
Protocol Number: 2018-0935 Slots available for MCL:
Key Information:
PI:
Wang, Michael
Contact:
Pedersen, Archie
Phone:
(713) 792-2860
Pager:
(713)
Protocol Key Eligibility Requirements for 2018-0935
Inclusion:
Exclusion:
Protocol Fact Sheet for 2018-0935
Protocol Abstract for 2018-0935
**Pending data from team
VLS-101 (antibody drug conjugate) for Hem Malignancies
Protocol Number: 2018-0996 Slots available for MCL:
5 out of 15 Key Information:
PI:
Wang, Michael
Contact:
Fischer, Kim
Phone:
(713) 563-4319
Pager:
(713) 606-4456
Protocol Key Eligibility Requirements for 2018-0996
Inclusion:
Age 18 or older ECOG 0-2 Histological diagnosis of MCL, FL, MZL, DLBCL, or RTL Presence of measurable lymphadenopathy or extranodal malignancy Adequate bone marrow function without hematopoietic support Adequate hepatic profile Adequate Renal Function Adequate coagulation profile Exclusion Criteria Malignancy involving the central nervous system Significant cardiovascular disease Significant screening ECG abnormalities Candidacy for hematopoietic stem cell transplantation or CAR T cell therapy, with access to HSCT or CAR T cells and a willingness to undergo such therapy Prior therapy with a TOT1-directed therapy or with a MMAE-containing drug Use of string inhibitor or inducer of CYP3A4 within 7 days prior to start of study therapy Use of a drug known to prolong the QT interval within 7 days prior to the start of study
Protocol Summary for 2018-0996
Protocol Abstract for 2018-0996
A Multicenter, Open-label, Expanded Access Study of KTE-X19 for the Treatment of Subjects with Relapsed/Refractory B-Cell Malignancies
Zuma 18
Protocol Number: 2019-0940 Slots available for MCL:
13 out of 20 Key Information:
PI:
Wang, Michael
Contact:
Badillo, Maria
Phone:
(713) 745-2714
Pager:
(713) 404-4313
Protocol Key Eligibility Requirements for 2019-0940
Inclusion: Exclusion:
**Pending data from team
Protocol Summary for 2019-0940
Protocol Abstract for 2019-0940
**Pending data from team
EXPLORE Xenografts to Personalize Therapies (PDX) in relapsed MCL
Protocol Number: 2017-0051 Slots available for MCL: 3 OUT OF 10 Key Information: PI: Wang, Michael
Contact: Badillo, Maria
Phone: (713) 745-2714
Pager: (713) 404-4313
Protocol Eligibility Requirements for 2017-0051
Inclusion:
Confirmed MCL tissue diagnosis. Patients must have relapsed/progressed after any therapy for MCL. Bi-dimensional measurable disease (bone marrow or GI only involvement is acceptable). Reasonable expectation that the patient can wait 3 - 6 months for generation of PDX data for subsequent treatment selection. The patient PDXs must have generated informative mouse xenograft data during Part 1 to participate in Part 2. The patient condition remains suitable for the selected therapy. If the patient receives prior therapy with a given agent (X) and progressed, but the testing in Part 1 found this agent to be effective in a combination, the patient remains eligible for this combination that includes agent X. Patients must have adequate organ function for drugs(s) or combination being utilized (dependent on the drug (s) being given)
Exclusion:
Known HIV infection. Patients with active hepatitis B infection (not including patients with prior hepatitis B vaccination; or positive serum Hepatitis B antibody). Known hepatitis C infection is allowed as long as there is no active disease and is cleared by GI consultation. Ineligible to participate in any Part 2 if any of the ff: Tumors do not engraft in the mice or do not respond to any of the selected agents and Tumors do not engraft in the mice or do not respond to any of the selected agents In Cohort 2, if disease progression occurs before Part 1 data are available, then they will be transferred to Cohort 1. Part 1 data contradict clinical judgment. The investigator should discuss with the PI and use the best discretion.
Protocol Summary for 2017-0051
**Pending data from team
Protocol Abstract for 2017-0051
Phase II Trial to assess the Efficacy of Ultra Low Radiation Dose delivered prior or after chemotherapy free targeted therapy for the Treatment of R/R MCL
Protocol Number: 2018-0348 Slots available for MCL: 71 out of 80
Key Information: *RadOnc Study* Radiation before or after SOC chemotherapy-free targeted therapy, immunotherapy or DR2IVE
PI: Bouthaina, Dabaja Contact: HEMERadOncResearch@mdanderson.org
Protocol Eligibility Requirements for 2018-0348
R/R with >=2 prior lines of therapy & progressive disease s/p any ibrutinib therapy. ECOG<2. Adequate bone marrow reserve, liver & renal function. Exclude where radiation field incudes marrow volume > 40%.
Protocol Abstract for 2018-0348
Protocol Summary for 2018-0348
Please Note: no fact sheet because this is considered a radiation-only study. A Phase 1 Safety and Efficacy Study of ADI-001 Anti-CD20 CAR-engineered Allogeneic Gamma Delta (γδ) T Cells in Adults with B Cell Malignancies, in Monotherapy and Combination with IL-2
Protocol Number: 2020-1137 Slots available for MCL: 2
Key Information:
2 prior lines of systemic therapy, including an anthracycline or alkylator and at least 1 BTK inhibitor and anti-CD20 monoclonal antibody. PI: Neelapu, Sattva Contact: Johncy, Swapna Phone: (713) 792-8251
Protocol Key Eligibility Requirements for: 2020-1137 Inclusion Patients with R/R B cell malignancies including DLBCL,HGBCL,MCL,FL,MZL, PMBCL, Burkitts Lymphoma. Prior therapies:MCL - 2 prior lines of systemic therapy, including an anthracycline or alkylator and at least 1 BTK inhibitor and anti-CD20 monoclonal antibody. Large B cell lymphomas including DLBCL, HGBCL, tFL, and PMBCL- 2 prior lines of therapy, including an anthracycline and anti-CD20 monoclonal antibody therapy. FL and MZL- 2 prior lines of systemic therapy, including an alkylator and an anti-CD20 monoclonal antibody therapy. Monotherapy with anti CD20 monoclonal antibody will not be considered as a line of therapy. Exclusion CNS Involvement ASCT within 45 days of screening
Known CD20 negative tumor Active uncontrolled fungal, bacterial, viral, protozoal, or other infection.
Any form of primary immunodeficiency (e.g., severe combined immunodeficiency disease). History of human immunodeficiency virus (HIV) infection. Active hepatitis B or hepatitis C.
Protocol Summary for 2020-1137
Phase 3 Study of Ibrutinib in Combination with Venetoclax in Subjects with Mantle Cell Lymphoma
Protocol Number: 2017-0238 Slots available for MCL: CLOSED TO NEW PATIENT ENTRY
Key Information: PI: Wang, Michael Contact: McClain, Chloe Phone: (713) 794-1392 Pager: (713) 404-6976
Protocol Key Eligibility Requirements for 2017-0238
Inclusion:
MCL with cyclin D1 in association with other relevant markers (eg, CD19, CD20, PAX5, CD5) or evidence of t(11;14), as assessed by CGs, FISH, or PCR At least 1 measurable site of disease that is >/= 2.0 cm LDi and measurable in 2 perpendicular dimensions per computed tomography (CT). Men and women ≥65 years of age, or if less than 65 years of age must have a TP53 mutation Adequate fresh or paraffin embedded tissue. LABS: ANC >1000 cells/mm^3 (1.0 x 10^9/L) Plt count >50,000 cells/mm^3 (50 x 10^9/L) Hgb >8.0 g/dL; Adequate hepatic and renal function defined as: AST/ALT < /=3.0 x ULN. CrCl >/=30 mL/min (Bili < /=1.5 x ULN, PT/ INR < 1.5 x ULN and aPTT < 1.5 x ULN
Exclusion:
CNS lymphoma. Blastoid variant of MCL Concurrent enrollment in another therapeutic investigational study or prior therapy, including ibrutinib or other BTK inhibitors Prior treatment with venetoclax or other BCL2 inhibitors Known HIV or active with hep C virus (HCV) or hep B. Subjects who are positive for hep B core antibody, HBsAg, or hep C antibody must have a negative PCR before enrollment. Those who are PCR positive will be excluded. Unable to swallow capsules or tablets, or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction.
Protocol Summary for 2017-0238
Protocol Abstract for 2017-0238
A Phase 3 Randomized, Open-Label, Multicenter Study Comparing Zanubrutinib (BGB-3111) plus Rituximab Versus Bendamustine plus Rituximab in Patients with Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation Protocol Number: 2019-0469 Slots available for MCL:
30
Key Information:
Newly diagnosed elderly MCL patient PI:
Wang, Michael
Contact:
Nava, Diana
Phone:
(713) 792-4255
Protocol Key Eligibility Requirements for: 2019-0469 Inclusion Exclusion
**Pending data from team
Protocol Fact Sheet for: 2019-0469
Protocol Abstract for: 2019-0469
A Phase 1/2a, Open-Label, Dose Escalation Trial of GEN3017 With Expansion Cohorts in Relapsed or Refractory CD30+ Classical Hodgkin Lymphoma and CD30+ Non- Hodgkin Lymphoma
Protocol Number: 2023-0613 Slots available for T-cell: 5 slots of 5 open
Key Information:
PI: Ahmed, Sairah Contact: releonard@mdanderson.org Phone:
An Open-Label, Phase 2 Trial of Nanatinostat in Combination with Valganciclovir in Patients with Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas (NAVAL-1)
Protocol Number: 2021-0463 Slots available for T-cell: 10 slots open Key Information:
1.EBV+ diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) 2. Extranodal NK/T-cell lymphoma (ENKTL) 3. Peripheral T-cell lymphoma (PTCL), including PTCL-NOS and angioimmunoblastic T-cell lymphoma (AITL): • 3a: Nanatinostat monotherapy • 3b: Nanatinostat + valganciclovir 4. Hodgkin lymphoma (HL) 5. Post-transplant lymphoproliferative disorder (PTLD) 6. Lymphomas associated with human immunodeficiency virus (HIV) infection (HIV-L): Plasmablastic, Burkitt, Hodgkin and DLBCL 7. EBV+ lymphomas other than the above PI: Nair, Ranjit Contact: Jenna Wixom Phone: (713) 416-3951
Protocol Key Eligibility Requirements for: 2021-0463
Protocol Abstract for 2021-0463
A Single-arm, Phase II Study to Evaluate the Efficacy and Safety of Linperlisib (YY-20394) Monotherapy in Patients with Relapsed or Refractory Peripheral T/NK Cell Lymphoma
Protocol Number: 2022-0235 Slots available for T-cell: 15 slots open Key Information:
. Diagnosis of one of the following histologic subtypes of PTCL, (PTCL-NOS) (AITL) (ALCL) ALK positive or ALK negative (NKTCL)(MEITL). • 1 or > line of systemic therapy. • Not a candidate for autologous or allogeneic transplantation. • For patients with CD30+ PTCL, progressed on or are ineligible or intolerant to brentuximab vedotin. • Has radiographically measurable disease as per Lugano Criteria with at least one measurable disease lesion > 1.5 cm
PI: Nair, Ranjit Contact: Thomas, Merlin Phone: (713) 745-6948
Protocol Key Eligibility Requirements for: 2022-0235
Protocol Abstract for 2022-0235
An open-label, multi-center, non-randomized phase I dose escalation study to investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ONO-4685 given as monotherapy in patients with relapsed or refractory T-cell Lymphoma
Protocol Number: 2021-1033 Slots available for T-Cell: Have to request from sponsor
Key Information:
Accepts relapsed refractory PTCL, CTCL Must have had 2 or greater lines of therapy CD30 positive must have received BV as prior tx No prior treatment with anti PD-1, anti PDL1 anticytotoxic T lymphocyte associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways PI: Iyer, Swaminathan Contact: Paras, Catherine Phone: 713-404-7848 Email: cparas@mdanderson.org
Protocol Key Eligibility Requirements for 2021-1033
Protocol Summary for 2021-1033
A Phase 1-2, Open-Label Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Activity of Tolinapant in Combination with Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Subjects with Relapsed/Refractory Peripheral T-cell Lymphoma
Protocol Number: 2022-0698 Slots available for T-Cell: Slot to be requested before consenting
Slot : Slot to be requested before consenting
Key Information:
R/R PTCL Two lines of treatment Measurable disease CD30+ must have received or ineligible for BV ECOG 0-2 Histology:
Subtypes-NKTCL, EATL MEITL,HSTCL,SPTCL,PTCL-NOS, AITL, FTCL,ALCL, Nodal peripheral T-cell. PI: Malpica Castillo, Luis E Contact: Lal, Ana Phone: 7137455078 Pager: klal@mdanderson.org
Protocol Key Eligibility Requirements for 2022-0698
Protocol Summary for 2022-0698
A Phase 1, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD70 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX130) in Adult Subjects With R/R T or B Cell Malignancies Protocol Number: 2020-0238 Slots available for T-Cell:
1 OUT OF 10 Key Information:
Must have CD70-expressing tumor DLBCL must have failed a treatment attempt with autologous CD19 CAR T cell therapy PTCL-NOS, leukemic and lymphomatous ATLL, or AITL should have failed ≥1 lines of systemic therapy ALCL should have failed, be ineligible for, or have refused combination chemotherapy and therapy with brentuximab vedotin in combination or as single agent ALK− ALCL should have failed a minimum of 1 prior line of therapy ALK+ ALCL should have failed a minimum of 2 prior lines of therapy MF or SS must have failed at least 2 of the following systemic therapies: Brentuximab vedotin, romidepsin, pralatrexate, mogamulizumab or chemotherapy PI:
Iyer, Swaminathan
Contact:
Tom, Jisha
Phone:
(713) 563-1429
Pager:
(713) 592-2311
Pending ranking for T-Cell (listed top until updated)
Protocol Eligibility Requirements for 2020-0238
Inclusion: Must have CD70-expressing tumor DLBCL must have failed a treatment attempt with autologous CD19 CAR T cell therapy DLBCL must have failed a treatment attempt with autologous CD19 CAR T cell therapy ALCL should have failed, be ineligible for, or have refused combination chemotherapy and therapy with brentuximab vedotin in combination or as single agent ALK− ALCL should have failed a minimum of 1 prior line of therapy, ALK+ ALCL should have failed a minimum of 2 prior lines of therapy MF or SS must have failed at least 2 of the following systemic therapies: Brentuximab vedotin, romidepsin, pralatrexate, mogamulizumab or chemotherapy. ECOG 0-1 Platelet count >25,000/mm3 and ANC >500/mm3 CrCl ≥50 mL/min, AST and ALT <3 x ULN, Total bilirubin <2 x ULN
Exclusion: Prior treatment with anti-CD70 targeting agents Prior allogeneic SCT Less than 60 days from autologous SCT at time of screening and with unresolved serious complications For DLBCL, prior treatment with CAR T cells or other modified T or natural killer (NK) cells except autologous CD19 CAR T cells Prior use of antitumor agents, including radiotherapy, 14 days prior to enrollment Active CNS manifestation of underlying disease in screening imaging Present or past malignant effusion that is or was symptomatic Present or past malignant effusion that is or was symptomatic
Protocol Summary for 2020-0238
Protocol Abstract for 2020-0238 View more available T-Cell protocols?
Yes
Concurrent Chemotherapy and Radiation Therapy for Newly Diagnosed Patients with Stage I/II Nasal NK Cell lymphoma
Protocol Number: 2013-0367 Slots available for T-Cell: 27 out of 40
Key Information: *RadOnc Study* Radiation (50.4-54Gy) + 3 inpatient cycles of DeVIC. No randomization.
PI: Bouthaina, Dabaja Contact: HEMERadOncResearch@mdanderson.org
Protocol Key Eligibility Requirements for 2013-0367
LABS: ANC > 1000, Bilirubin < /= 1.5 ULN ALT < /= 2 x ULN, AST < /= 2xULN, CrCl >/= 50ml/min, LVEF >= 50% No active infection No pre-existing cardiovascular disease requiring ongoing treatment: CHF, cardiomyopathy, uncontrolled arrhythmia; unstable angina, recent MI (w/in 6 mos.). No prior radiation at primary disease site if re-treatment would exceed known dose tolerance limits.
Protocol Summary for 2013-0367
Protocol Abstract for 2013-0367
An Expanded Access Program to Provide Sugemalimab for the Treatment of Relapsed or Refractory Extranodal Natural Killer/T-Cell Lymphoma (R/R ENKTL)
Protocol Number: 2021-0971 Slots available for T-cell: 10 slots
Key Information:
PI: Nair, Ranjit Contact: Thomas, Merlin Phone: 713-203-2025
Phase 1, Open-Label Study of Autologous SIRPα-low Macrophages (SIRPant- M) Administered by Intratumoral Injection Alone or in Combination with Focal External-Beam Radiotherapy in Participants with Relapsed or Refractory Non- Hodgkin's Lymphoma
Protocol Number: 2023-0610 Slots available for FL: 6 of 6 Slot
Key Information:
PI: Strati, Paolo Contact: Laurel Deaton Phone: fldeaton@mdanderson.org
A Phase 3 Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects with Relapsed/Refractory Follicular Lymphoma Protocol Number: 2022-0298 Slots available for FL: 10 Out of 10
Key Information:
Phase 3 randomized study for R/R gr 1-3a FL (POD24 or ≥ 2 prior lines of systemic therapy). Subjects will be randomized to receive either axi-cel or SOCT (R2, BR, or R-CHOP).
PI: Nastoupil, Loretta Contact: Ly Dsouza Phone: 832-817-8154 Email: ldsouza@mdanderson.org
Protocol Key Eligibility Requirements for 2022-0298
Protocol Summary for 2022-0298
A Phase 3 Randomized, Open-Label, Multicenter Study of Zanubrutinib (BGB-3111) Plus Anti-CD20 Antibodies Versus Lenalidomide Plus Rituximab in Patients With Relapsed/Refractory Follicular or Marginal Zone Lymphoma Protocol Number: 2023-0335 Slots available for FL: Open
Key Information:
Previously treated with 1+ prior line systemic therapy. Previously treated with 1+ prior line systemic therapy.
PI: Nastoupil, Loretta Contact: Lauren Wynn Phone: 346-722-0275 Email: lrwynn@mdanderson.org
Protocol Summary for 2023-0335
A Phase 1/2, Open-label Study of Valemetostat in Combination with Rituximab and Lenalidomide in Relapsed or Refractory Follicular Lymphoma Protocol Number: 2022-0551 Slots available for FL: 12 Out of 12
Key Information:
Previously treated with at least 1 prior Anti CD20 therapy followed by relapsed, refractory or progressive disease.
PI: Nastoupil, Loretta Contact: Lauren Wynn Phone: 346-722-0275 Email: lrwynn@mdanderson.org
Protocol Key Eligibility Requirements for 2022-0551
Protocol Summary for 2022-0551
A Phase I/II Open Label, Single Center, Study of the Combination of ALX148, Rituximab and Lenalidomide in Patients with Indolent and Aggressive B-cell Non-Hodgkin Lymphoma
Protocol Number: 2021-0226 Slots available for FL: 24 OUT OF 24 Phase II is open Key Information: Phase II: Frontline treatment of indolent B-NHL; no prior systemic treatment, high tumor burden disease, Stage III or IV, ECOG 0-1Phase II: Frontline treatment of indolent B-NHL; no prior systemic treatment, high tumor burden disease, Stage III or IV, ECOG 0-1
PI: Strati, Paolo Contact: Davidson, Jeffry Phone: 713-745-5095 Pager:
Protocol Key Eligibility Requirements for: 2021-0226
Protocol Fact Sheet for: 2021-0226
A Phase 2, Open-label, Multicenter Study of the Safety and Efficacy of TAK-007 in Adult Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Protocol Number: 2021-0583 Slots available for FL: 1 of 1 Slot
Key Information:
Study drug: TAK-007 (cryopreserved cord blood NK CAR).
TAK-007 is a cryopreserved cord blood NK CAR
Accepts R/R large B-cell lymphoma subtypes, FL gr 1-3b, and MZL after 2 lines of systemic therapy
PI: Strati, Paolo Contact: Laurel Deaton Phone: fldeaton@mdanderson.org
Protocol Eligibility Requirements for 2021-0583 Major Inclusion Criteria: 1. R/R refractory CD19 expressing disease after at least 2 lines of therapy: a. LBCL, including subtypes defined by the WHO and FL gr 3b. (must have prior anti-CD20 mAb and an anthracycline containing chemotherapy regimen and failed or be ineligible for high-dose chemotherapy and ASCT) b. FL and MZL (must have prior anti-CD20 mAb and an alkylating agent) 2. ECOG 0 or 1 3. ANC >500; plts >50; eGFR ≥30 mL/min 4. LVEF ≥40% 5. No evidence of clinically relevant pericardial effusion, and no acute clinically significant ECG findings. 6. Absence of Grade ≥2 pleural effusion. Baseline O2 sat >92% on RA
Major Exclusion Criteria: 1. CNS lymphoma, BL, MCL, LPL, or Richter's 2. Hx of anti-CD19 therapy 3. Hx of malignancy other than nonmelanoma skin cancer, carcinoma in situ, low-grade tumors deemed to be cured and not treated with systemic therapy unless disease free for ≥3 years 4. Auto or allo SCT within 3 months 5. Active infection. 6. Active HIV, HBV, HCV, or Covid-19 infection at screening 7. Clinically relevant CNS disorder 8. Clinically significant cardiac condition within 12 months 9. DVT or PE within 6 months 10. Hx of autoimmune disease or solid organ transplantation, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years.
Protocol Summary for 2021-0583
A Multicenter, Phase 1, Open-label, Dose-escalation and Expansion Study of TNB-486, a Bispecific Antibody Targeting CD19 in Subjects with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
Protocol Number: 2021-0091 Slots available for FL: 2 OUT OF 2
Key Information:
Subject has biopsy proven B-NHL Subject has biopsy proven RR DLBCL or HGBL Subject has biopsy proven RR FL (Grade 1-3a) Subject has biopsy proven RR FL Subject has greater than 1 measurable disease site(s) as defined in the RECIL 2017 classification Subject has received at least 2 lines of therapy to which the subject has been either refractory or has subsequently relapsed. In order to be eligible for this study subjects must not be candidates for treatment regimens known to provide clinical benefit in B-NHL. PI: Nair, Ranjit Contact: Ana Lal Phone: (713) 745-5078
A Phase 1/2 Open-label, Multicenter Study Evaluating the Safety and Efficacy of KITE-363, an Autologous Anti-CD19/CD20 CAR T-cell Therapy, in Subjects With Relapsed and/or Refractory B-cell Lymphoma
Protocol Number: 2020-1136 Slots available for FL: 1 OUT OF 10
Key Information:
Currently in dose escalation phase, slots are staggered . PI: Loretta Nastoupil Contact: Ly, Dsouza Phone: (832)-817-8154
Protocol Eligibility Requirements for 2020-1136 Inclusion:
Exclusion:
Protocol Summary for 2020-1136
CC-99282 (next gen cereblon inhibitor)+/- Rituximab for R/R NHL
Protocol Number: 2018-1160 Slots available for FL: 20
Key Information:
multiple arms available. 0.2mg and 0.4mg 14/28 days (14 days on 14 days off) protocol is currently enrolling R/R DLBCL and R/R FL only. PART B Dose expansion 2 prior lines or DLBCL 1 prior line AND not eligible for SCT ANC > 1.5, plt >75, CrCl > 60 ECOG 0-2 no symptomatic CNS involvement PI: Nastoupil, Loretta Contact: Averill, Barbara Phone: (713) 745-9910 Pager: (713) 404-7577
Protocol Eligibility Requirements for 2018-1160
Inclusion:
DLBCL, FL, MCL, PCNSL with relapsed/refractory disease with at least 2 prior lines of therapy. Measurable disease ECOG 0-2 ANC >/= 1.5 x 109/L without growth factor support for 7 days (14 days if pegfilgastrim), Hgb > 8 g/dL, plt >75 x 109/L without transfusion for 7 days, Estimated serum creatinine clearance of > 50 mL/min
Exclusion Criteria
Life expectancy >2 months prior CAR-T or other T-cell targeting treatment < 4 weeks prior to starting CC-99282 prior therapy with CRBN-modulating drug (eg, lenalidomide, avadomide/CC-122, pomalidomide) < 4 weeks prior to starting CC-99282 symptomatic CNS involvement of disease (does not apply to PCNSL subjects) Peripheral neuropathy NCI CTCAE Grade 2 Subject had prior autologous SCT < 3 months prior to starting CC-99282 and any treatment-related toxicity is unresolved (grade > 1) Subject had prior allogeneic SCT with either standard or reduced intensity conditioning < 6 months prior to starting CC-99282 and any treatment-related toxicity is unresolved (grade > 1) Prior radiotherapy within one month prior to starting study drug
Protocol Summary for 2018-1160
Protocol Abstract for 2018-1160
A Phase 1 Safety and Efficacy Study of ADI-001 Anti-CD20 CAR-engineered Allogeneic Gamma Delta (γδ) T Cells in Adults with B Cell Malignancies, in Monotherapy and Combination with IL-2
Protocol Number: 2020-1137 Slots available for FL:
1
Key Information:
2 prior lines of systemic therapy, including an anthracycline or alkylator and at least 1 BTK inhibitor and anti-CD20 monoclonal antibody. PI:
Neelapu, Sattva
Contact:
Johncy, Swapna
Phone:
(713) 792-8251
Protocol Key Eligibility Requirements for: 2020-1137 Inclusion Patients with R/R B cell malignancies including DLBCL,HGBCL,MCL,FL,MZL, PMBCL, Burkitts Lymphoma. Prior therapies:MCL - 2 prior lines of systemic therapy, including an anthracycline or alkylator and at least 1 BTK inhibitor and anti-CD20 monoclonal antibody. Large B cell lymphomas including DLBCL, HGBCL, tFL, and PMBCL- 2 prior lines of therapy, including an anthracycline and anti-CD20 monoclonal antibody therapy. FL and MZL- 2 prior lines of systemic therapy, including an alkylator and an anti-CD20 monoclonal antibody therapy. Monotherapy with anti CD20 monoclonal antibody will not be considered as a line of therapy. Exclusion CNS Involvement ASCT within 45 days of screening
Known CD20 negative tumor Active uncontrolled fungal, bacterial, viral, protozoal, or other infection.
Any form of primary immunodeficiency (e.g., severe combined immunodeficiency disease). History of human immunodeficiency virus (HIV) infection. Active hepatitis B or hepatitis C.
Protocol Summary for 2020-1137
A Phase 1, Multicenter, Open-Label Study of CB-010, a CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy in Patients with Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma Protocol Number: 2020-1041
Slots available for FL:
5 OUT OF 5
Key Information:
Phase 1 study of CB-010, a CRISPR-edited allogeneic anti-CD19 CAR-T cell therapy in R/R B-cell NHL (DLBCL, tFL, PMBCL, HGBCL, MCL, FL, and MZL) PI:
Nastoupil, Loretta
Contact:
Dsouza, Ly
Phone:
832-817-8154
Protocol Eligibility Requirements for 2020-1041
Inclusion: DLBCL, HGBL, tFL, PMBCL Prior therapy must include anti-CD20 Ab and anthracycline and 1 or more of the following: Primary refractory diseaseNo response to second or more lines of therapy Refractory post ASCT FL or MZL Failed an anti-CD20 Ab and alkylating agent Best response to most recent therapy was PD MCL Failed anti-CD20 Ab, alkylating agent, and BTKi ECOG of 0 or 1 Oxygen saturation > 92% on room air with ≤ Grade 1 dyspnea Cardiac ejection fraction > 50% and no evidence of pericardial effusion or clinically significant ECG findings Laboratory parameters as follows: Serum albumin ≥ 3.0 g/dL; ALT/AST ≤ 2.5 × ULN; ANC ≥ 1000/uL; Platelet count ≥ 75,000/uL; Serum creatinine ≤ 1.5 × ULN, or calculated creatine clearance > 60 mL/min by Cockcroft Gault formula or estimated glomerular filtration rate > 60 mL/min/1.73 m2; Total bilirubin ≤ 1.5 mg/dL
Exclusion: History of prior therapy with an anti-CD19 targeting agent Active acute or chronic GvHD requiring therapy History of allogeneic stem cell transplantation ASCT within 8 weeks of informed consent Clinically significant CNS dysfunction or disease. Current thyroid disorder (including hyperthyroidism). Hypothyroidism controlled with a stable dose of hormone replacement therapy is permitted History of HIV. Active hepatitis B or C virus infection. Requirement for urgent therapy because of tumor mass effects such as bowel obstruction or blood vessel compression Presence of pleural, peritoneal or pericardial catheter Clinically significant pleural effusion History of significant cardiac disease within 12 months of enrollment Concurrent or previous other malignancy within 2 years of study entry, except curatively treated malignancies. History of autoimmune disease resulting in end organ injury or requiring within the last 2 years systemic immunosuppressive or disease modifying agents
Protocol Summary for 2020-1041
Phase 1 Open-label, Multicenter Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of IGM-2323 in R/R NHL
Protocol Number: 2019-0644 Slots available for FL: 30 OUT OF 30 CNPE
Key Information:
DOSE ESCALATION must be CD20+ 2 prior lines FL, DLBCL, or other histology ECOG 0-1 excludes double, triple hit and Richter's transformation PI: Nastoupil, Loretta Contact: Averill, Barbara Phone: (713) 745-9910 Pager: (713) 404-7577
Protocol Key Eligibility Requirements for: 2019-0644 Inclusion Histologically confirmed FL Grades 1-3a, or Grade 3b. Or Histologically confirmed DLBCL or trFL. Or Additional CD20-positive NHL R/R to at least 2 prior systemic treatment regimens Not eligible for aHSCT, due to chemoresistant disease, medically unfit for transplant, or unwilling to proceed, and there is no readily available standard therapy expected to improve survival. Medical fitness criteria include cardiac ejection fraction > 50%, Creatinine < LLN, Pulmonary function tests of FEV1/DLCO > 70% predicted, and successful mobilization of CD34+ cells. Eligibility will be assessed by the treating physician and rationale for assessment will be recorded. Unwillingness to proceed per the patient will be documented through the informed consent process, after aHSCT risks and benefits are clearly described to the patient and the subject has been made aware of all therapeutic options. At least 1 bi-dimensionally measurable lesion (> / = 1.5 cm) in longest dimension by CT scan. ECOG Status of 0 or 1. LABS: ANC > / = 1000/mm3; Total hemoglobin > / = 9 g/dL without transfusion within 21 days prior to first dose of IGM-2323; Platelet count > / = 75,000/mm2 without transfusion within 14 days prior to the first dose of IGM-2323; Serum Cr < ULN, or estimated CrCL > / = 50 mL/min; ALT/AST < / = 3 x ULN; Total bilirubin < / = 1.5 mg/dL, (except in subj with Gilbert's Syndrome < / = 1.5 mg/dL of direct bilirubin). Cardiac ejection fraction > / = 50%, by ECHO or MUGA. Baseline oxygen saturation > 92% on room air. No clinically significant pleural effusion. Subjects treated with alemtuzumab, fludarabine, cladribine, or pentostatin within 6 months before the first dose of IGM-2323 may be enrolled only with Medical Monitor approval.
Exclusion Known Double/Triple Hit Lymphoma (MYC, and BCL-2 or BCL-6 translocation). CLL, or Richters transformation. Known lack of cancer cell CD20 expression as measured by IHC, flow cytometry, gene expression, or another assay. Current eligibility for ASCT in subjects with R/R DLBCL or R/R trFL. Impending obstruction due to lymphoma, such as superior vena cava syndrome, or any other sensitive site at risk for expanding mass effect. Absolute B-cell lymphocyte count > 5,000/mm3 Prior AlloSCT, solid organ transplant, ASCT within 100 days prior to first IGM 2323 administration Lack of response to prior treatment with CAR-T therapy, subjects with less than 6 months from prior CAR-T therapy to first dose of IGM-2323, and prior CAR-T therapy only allowed with Medical Monitor approval. Prior use of any mAb protein therapeutic, within 3 weeks prior to the first dose of IGM-2323. Prior use of any radioimmunoconjugate or antibody drug conjugate within 4 weeks prior to the first dose of IGM-2323. Prior treatment with systemic immunotherapeutic agents, including but not limited to cytokine therapy and anti-CTLA4, anti-PD-1, anti-PD-L1 therapeutic antibodies within 4 weeks prior to first dose of IGM-2323. Treatment with any chemotherapeutic agent or treatment with any other anti-cancer agent within 3 weeks prior to first IGM-2323 administration. Treatment with radiotherapy within 1 week prior to the first IGM-2323 administration. If subjects have received radiotherapy within 4 weeks prior to the first IGM-2323 administration, subjects must have at least 1 measurable lesion outside of the radiation field. Subjects who have only 1 measurable lesion that was previously irradiated but subsequently progressed are eligible. CNS lymphoma Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease. Subjects with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurologic deficits as judged by the Investigator are allowed. Subjects with a history of epilepsy who have had no seizures in the past 2 years while not receiving any anti-epileptic medications are allowed in the expansion cohorts only. Known active bacterial, viral, fungal, mycobacterial, parasitic or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to the first IGM-2323 administration. Subjects with a history of confirmed progressive multifocal leukoencephalopathy. Known or suspected chronic active Epstein Barr Virus infection Positive serologic or PCR test results for acute or chronic HBV infection. Acute or chronic HCV infection. Subjects who are positive for HCV antibody must be negative for HCV by PCR to be eligible for study participation. Known history of HIV seropositivity. Active autoimmune disease. Received systemic immunosuppressive medications with the exception of corticosteroid treatment < / = 10 mg/day prednisone or equivalent within 2 weeks prior to first dose of IGM-2323. Subj who received acute, low-dose, systemic immunosuppressant meds may be enrolled after discussion w/ and w/ approval of Med Monitor. Use of topical, intranasal, or inhaled corticosteroids permitted. Use of mineralocorticoids for management of orthostatic hypotension permitted. Use of physiologic dose of corticosteroids for management of adrenal insufficiency permitted. Use of corticosteroids to prevent CT contrast dye reaction Presence of an abnormal ECG or history of rhythm disorder that is clinically significant in the Investigator's opinion, including uncontrolled atrial fibrillation/flutter or any unstable arrhythmias, second or third-degree AV Unstable angina, myocardial infarction, cardiac angioplasty or stenting within the last 6 months. Significant congestive heart failure, such as New York Heart Association Class III or IV. Significant active pulmonary disease History of symptomatic DVT or pulmonary embolism within 6 months of enrollment. History of upper extremity line related DVT within 3 months.
Protocol Fact Sheet for 2019-0644
Protocol Abstract for 2019-0644
A Phase 1/2, First in Human, Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Triple-specific T-cell Engager 1A46 in Adult Patients with Advanced CD20 and/or CD19 Positive B-cell Hematologic Malignancies
Protocol Number: 2021-1214 Slots available for FL: 1 out of 1
Key Information:
1A46 is a tri-specific T-cell activating antibody that binds to human CD3, CD19 and CD20. Infusions are weekly for the first 8 cycles (24 weeks) and then once q3 weeks for the next 8 cycles. Patients will be hospitalized for 72 hours following each new dose level (3 total dose levels); subsequent doses may be outpatient. Trial is in dose escalation phase. PI: Ahmed, Sairah Contact: lcebarle@mdanderson.org Phone:
Protocol Fact Sheet for 2021-1214
A Phase 1b Multicenter, Open-label, Study of JNJ-90009530, an Autologous Anti-CD20 CAR-T Cell Therapy in Adult Participants with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Protocol Number: 2023-0706 Slots available for FL: 5 out of 5
Key Information:
Study Treatment: Study drug is JNJ90009530, CD20 directed, autologous CAR-T Conditioning chemotherapy with Fludarabine/Cyclophosphamide Bridging allowed (if needed) following apheresis Key Inclusion: CD20 positive disease R/R disease after at least 2 lines of standard therapy, with measurable disease per Lugano criteria ECOG 0-1 CrCl > 50 mL/min Hgb > 8, ANC > 1, ALC > 0.3, Plt > 50,000 LVEF > 45% Key Exclusion: Active CNS disease (history of treated CNS disease allowed) HHV8+ DLBCL, Burkitt's Previous allogeneic transplant History of stroke, MI, CHF, DVT, PE within 6 months of screening PI: Ahmed, Sairah Contact: releonard@mdanderson.org Phone:
A Phase 1, First-in-Human, Dose Escalation Study of the JNJ-75348780 Bispecific Antibody Targeting CD3 and CD22 in Participants with NHL and CLL
Protocol Number: 2021-0203 Slots available for FL: 0 OUT OF 10 Key Information: Patients with R/R B-cell NHL DLBCL: received or not eligible for high-dose chemotherapy and autologous stem cell transplantation with curative intent. FL/MZL (except MALT) or WM: Previously treated with at least 2 prior line of systemic therapy containing an anti-CD20 antibody. MCL: Previously treated with at least 1 prior line of systemic therapy containing an anti-CD20 antibody. Patients with CLL or SLL: R/R with at least one prior line of systemic therapy containing a BTK inhibitor. ECOG 0-1 Adequate lab parameters without transfusion for at least 7 days prior to first dose of study drug
PI: Chihara, Dai Contact: Amanda Nunmaker Phone: 346-725-2997 Email: AMnunmaker@mdanderson.org
Phase 2 Trial of Obinutuzumab and CC-99282 for Patients with previously untreated high tumor burden Follicular lymphoma
Protocol Number: 2023-0063 Slots available for FL: 36 OUT OF 36
Key Information: Previously untreated high tumor burden FL
Inclusions: - Follicular lymphoma grade 1-3a - Stage II, III, or IV disease - ECOG ≤2 - High tumor disease based on GELF criteria - Measurable disease - Adequate organ and marrow function - Agree to the pregnancy prevention plan for CC-99282
Exclusions: - Known active CNS lymphoma or leptomeningeal disease - Uncontrolled active significant infection, including HIV, Hepatitis C, or Hepatitis B - History of immunodeficiency or concurrent systemic immunosuppressant therapy - Clinically significant cardiovascular disease - QTcF ≥ 470 msec - Prior exposure to CD20 mAb or IMiDs, independently from indication - Known history of symptomatic deep vein thrombosis or pulmonary embolism - Neuropathy >Grade 1
PI: Chihara, Dai Contact: Amanda Nunmaker Phone: 346-725-2997 Email: AMnunmaker@mdanderson.org
A Phase II Study of Acalabrutinib, Lenalidomide and Rituximab (aR2) in Patients with Previously Untreated Follicular Lymphoma
Protocol Number: 2020-0034 Slots available for FL: 14 OUT OF 24 Key Information: Untreated FL grade 1, 2, 3a with measurable disease that meets at least 1 GELF criteria
Revlimid & Rituximab billed to INS; Acalabrutinib provided by sponsor. Bi-dimensionally measurable disease, with at least one nodal lesion >/= 1.5 cm instead of >/= 2.0cm
PI: Strati, Paolo Contact: Lisa Hitchcock-Weber Phone: 713-492-3044 Email: LMHitchcock@mdanderson.org
Protocol Key Eligibility Requirements for: 2020-0034 Inclusion:
Histologically confirmed CD20+ follicular lymphoma, grade 1, 2, or 3a Have had no prior systemic treatment for lymphoma Bi-dimensionally measurable disease, with at least one mass lesion ≥ 1.5 cm in longest diameter by CT, PET/CT, and/or MRI. High tumor burden disease, defined by meeting 1 or more GELF criteria Stage III or IV disease Exclusion:
Known active CNS lymphoma or leptomeningeal disease, except subjects with a history of central nervous system lymphoma treated and in remission > 6 months. Evidence of diffuse large B-cell transformation Grade 3b FL Any prior history of other malignancy besides FL or marginal zone lymphoma, unless the patient has been free of disease for ≥ 5 years and felt to be at low risk for recurrence by the treating physician
Protocol Fact Sheet for: 2020-0034
Randomized Trial of Radiation Therapy with and without Rituximab for patients with Stage I II Follicular Lymphoma grade I/II/IIIa
Protocol Number: 2011-0283 Slots available for FL: 96 OUT OF 130
Key Information:
*RadOnc Study* Newly diagnosed patients with stage I and II follicular lymphoma, pathologically confirmed at MDACC to be grade 1, 2 or 3a that is not double hit+. PI: Bouthaina, Dabaja Contact: HEMERadOncResearch@mdanderson.org
Office Mobile:
Protocol Key Eligibility Requirements for 2011-0283
Inclusion:
Newly diagnosed patients with stage I and II follicular lymphoma, pathologically confirmed at MDACC to be grade 1 or 2 or 3a. Prophylactic use of lamivudine in patients that have antibody +, but no active infection will be up to the treating physician ANC ≥ 1000/mm3, Platelets ≥ 80,000/mm3, Hemoglobin ≥ 8g/dL, Bilirubin ≤ 1.5 times ULN, ALT ≤ 2 times the ULN or AST) ≤ 2 times the ULN, ECOV < /= 3, serum CR < /= 2.5 mg/dL No prior known allergic reaction to monoclonal antibodies
Exclusion: Patients with active Hepatitis B and/or Hepatitis C infection Patients with known HIV infection Patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections are resolved Patients who had previous radiation dose to the site of the current primary disease, which would lead to violation of known radiation tolerance limit of that particular site if treated again Patients with pre-existing cardiovascular disease requiring ongoing treatment. This includes:Congestive heart failure III/IV as defined by NYHA Uncontrolled cardiac arrhythmia Unstable angina pectoris Recent MI (within 6 months)
Protocol Summary for 2011-0283
Protocol Abstract for 2011-0283
A Phase 1, First-in-Human, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-67856633, an Inhibitor of MALT1, in Participants With NHL and CLL
Protocol Number: 2020-0452 Slots available for FL: 15 OUT OF 15 CNPE
Protocol is terminated.
Key Information:
ECOG of 0-1 Labs: Hgb ≥8 g/dL, Plt ≥75×109/L, ANC ≥1.0×109/L, AST, ALT, GGT, and alkaline phosphatase ≤2.5× ULN, Serum total bilirubin ≤1.5× ULN, calculated or measured creatinine clearance ≥40 mL/min. Exclusion: Known active CNS involvement, prior solid organ transplant, active autoimmune disease requiring systemic immunosuppressive meds and active or chronic Hep B, C, HIV infection. PI: Samaniego, Felipe Contact: jennramos@mdanderson.org Phone: 713-563-5426
Protocol Eligibility Requirements for 2020-0452 Inclusion: ECOG of 0-1 Hgb ≥8 g/dL, Plt ≥75×109/L, ANC ≥1.0×109/L, AST, ALT, GGT, and alkaline phosphatase ≤2.5× ULN, Serum total bilirubin ≤1.5× ULN, calculated or measured creatinine clearance ≥40 mL/min. Exclusion: Known active CNS involvement prior solid organ transplant active autoimmune disease requiring systemic immunosuppressive meds active or chronic Hep B, C, HIV infection
Protocol Summary for 2020-0452
View more available FL protocols?
Yes
A PHASE 1B/3 DOUBLE-BLIND, RANDOMIZED, ACTIVE-CONTROLLED, 3-STAGE, BIOMARKER ADAPTIVE STUDY OF TAZEMETOSTAT OR PLACEBO IN COMBINATION WITH LENALIDOMIDE PLUS RITUXIMAB IN SUBJECTS WITH RELAPSED/REFRACTORY FOLLICULAR LYMPHOMA
Protocol Number: 2020-0272 Slots available for FL: 15 slots
Key Information:
FL with at least one prior line of therapy, no prior exposure to revlimid or EZH2 inhibitor allowed protocol now in randomized double blind portion PI: Nastoupil, Loretta Contact: Averill, Barbara Phone: (713) 745-9910
Protocol Eligibility Requirements for 2020-0272
Inclusion: Confirmed FL, grades 1 to 3A. Must have been previously treated with at least 1 prior systemic chemotherapy, immunotherapy, or chemoimmunotherapy Must have documented relapsed, refractory, or PD after treatment with systemic therapy (refractory defined as less than PR or disease progression < 6 months after last dose). measurable disease as defined by the Lugano Classification. ECOG performance status of 0, 1, or 2. Have provided sufficient tumor tissue for EZH2 mutation testing to allow for stratification. If EZH2 mutation status is known from site-specific testing, subjects can be enrolled, but additional tissue will be required for confirmatory testing of EZH2 status at study-specific laboratories. If the archival tumor sample was collected more than one year prior to administration of the first dose (day 1), then a fresh biopsy must be provided. Fresh tumor biopsy is appropriate except for procedures deemed to result in unacceptable risk because of the anatomical location including brain, lung/mediastinum, pancreas, or endoscopic procedures extending beyond the esophagus, stomach, or bowel. Archival tumor biopsy sections are also acceptable. Adequate renal function defined as calculated creatinine clearance ≥40 mL/minute per the Cockcroft and Gault formula or local institutional standard formula. Adequate bone marrow function:ANC ≥750/mm3 (≥0.75 × 109/L) Without growth factor support for at least 14 days. Platelets ≥75,000/mm3 (≥75 × 109/L) Evaluated at least 7 days after last platelet transfusion. Hemoglobin ≥9.0 g/dL May receive transfusion Adequate liver function: Total bilirubin ≤1.5 × the ULN except for unconjugated hyperbilirubinemia of Gilbert's syndrome. ALP (in the absence of bone disease), ALT, and AST ≤3 × ULN (≤5 × ULN if subject has liver metastases). Exclusion: Prior exposure to tazemetostat or other inhibitor(s) of EZH2. Prior exposure to lenalidomide for the treatment of FL. Subjects who have mixed or transformed histology. Has a prior history of T-LBL/ T-ALL. Subjects with uncontrolled leptomeningeal metastases or brain metastases or history of previously treated brain metastases. Significant cardiovascular impairment: history of congestive heart failure greater than NYHA Class II, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months of the first dose of study drug; or cardiac ventricular arrhythmia. Prolongation of corrected QTcF to >480 msec at screening or history of long QT syndrome. Venous thrombosis or pulmonary embolism within the last 3 months before starting tazemetostat. whereas subjects greater than 3 months since deep vein thrombosis/pulmonary embolism are eligible but recommended to receive prophylaxis. Have an active infection requiring systemic therapy. Known hypersensitivity to any component of tazemetostat, lenalidomide, or rituximab. Inability to be treated with a Pneumocystis prophylaxis medication. Subjects who have undergone a solid organ transplant. Subjects with malignancies other than FL. Exception: Subjects with another malignancy who have been disease-free for 5 years, or subjects with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
Protocol Summary for 2020-0272
Protocol Abstract for 2020-0272
CG-806 (Pan-FLT3/BTK Multi-Kinase Inhibitor) for R/R CLL/SLL & NHL
Protocol Number: 2019-0313 Slots available for FL: 15 OUT OF 18 5/5/22 Open for enrollment
Study is on temporary enrollment hold to complete data collection for G3 substudy as all slots have been filled.
No longer requires 2 or more prior lines of therapy, allows for one or more lines of therapy for all subtypes of NHL and CLL. G3 study has 2 slots available for the 200mg slot and cohort 6 is filled but may consider additional patients.
Key Information:
No longer requires 2 or more prior therapies. Only requires one or more prior therapies. ECOG < /= 2 NHL pt must have measurable disease of 1.5cm or greater CLL must have clonal population of lymphocytes in their blood and lymphocytosis > 5 x 10^9cells/L or hepatomegaly or splenomegaly consistent with disease infiltration Prior use of iburutinib allowed enrollment currently on hold and waiting on amendment 7 approval for new formulation. PI: Samaniego, Felipe Contact: Ramos, Jennifer Phone: (713) 563-5426
Protocol Key Eligibility Requirements for 2019-0313
Inclusion: Pathologically documented relapsed or refractory B cell NHL or CLL/SLL who have failed or are intolerant to 2 or more lines of established therapy, or for whom no other treatment options are available in the opinion of the investigator. - Resistance is defined as having failed to achieve a CR or PR with the most recent line of therapy Patients with FL, MZL and WM must require systemic therapy. All patients must have measurable disease. For NHL patients, tumor masses these must be bidimensionally measurable by physical examination, (CT, MRI or PET-CT. When measurable disease consists of peripheral lymph nodes, the target lymph nodes must be >/=1.5 cm in longest diameter. Patients with CLL must have a clonal population of lymphocytes in their blood and a lymphocytotosis of> 5 x 1 0J\9 cells/L. Patients with WM must have a monoclonal immunoglobin identifiable with SPEP whose concentration is elevated above normal limits. Prior use of ibrutinib or other covalent or non-covalent BTK inhibitor is allowed; the patient is eligible even after failing ibrutinib or other covalent or non-covalent BTK inhibitor due to lack of response or adverse events including atrial fibrillation. Patients who have had prior Auto or Allo SCT are eligible as long as they are >90 days post-transplant and do not require systemic immunosuppressive treatment for GVHD. Patients may have received prior radiation but must be >21 days since the last dose of external beam radiation therapy. Life expectancy of at least 2 months ECOG < /= 2 Cardiovascular parameters that must be met within 28 days of study treatment: - QTcF < /=450 msec for males, QTcF < /=470 msec for females Hematologic parameters that must be met within 28 days of study treatment: - ANC>/= 1,000 cells/µL - Platelet count>/= 50,000 cells/µL - If neutropenia or thrombocytopenia is believed to be due to marrow infiltration with malignant cells then there are no lower limits for the absolute neutrophil or platelet count for initiation or re-initiation of study drug retreatment. - INR/PT and aPTT < /=1.5 times ULN Renal & Liver function parameters that must be met within 28 days of study treatment: -All patients must have a CrCl >/= 60 ml/min, Adequate liver function tests (LFT): Total and direct bilirubin < /= 1.5 x the institutional ULN; AL T/AST < /= 2.5 x ULN Exclusion Criteria: Receipt of cytotoxic therapy within the preceding 14 days, or within 5 half-lives for prior noncytotoxic agents, prior to first study treatment administration Unresolved clinically significant toxicities of Grade 2 or higher from prior therapies Treatment with other investigational drugs within 14 days prior to first study treatment administration Patients with GVHD requiring systemic immunosuppressive therapy Patients with a known bleeding diathesis including anti-coagulation with any form of anticoagulant, coagulation factor deficiency, coagulopathy, prior major bleeding episode unrelated to surgery or trauma or stroke. Patients with another active malignancy requiring systemic therapy Leptomeningeal or CNS disease Uncontrolled auto-immune hemolytic anemia Major surgery < /= 14 days prior to signature of ICF and no minor surgery < /= 3 days prior to signature of ICF (with the exception of intravenous (IV) access placement, e.g. Hickman or PICC). Uncontrolled serious illness or medical conditions, which in the Investigator's opinion could hamper understanding of the study by the patient, patient's compliance to study treatment, patient's safety, or interpretation of study results. Need to concurrently take drugs that are substrates or known moderate or strong inhibitors of CYP2C8, CYP2C9, and CYP3A4/5 and drugs associated with a high risk of QT prolongation and torsades de pointes
Protocol Summary for 2019-0313
Protocol Abstract for 2019-0313
A Multicenter, Open-Label, First-In-Human, Multiple Expansion Cohort, Phase 1/2 Study to Evaluate the Safety and Efficacy of DR-01 in Adult Subjects with Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas
Protocol Number: 2022-0437 Slots available for t-cell: NEED PRIOR APPROVAL FROM SPONSOR FOR SLOT AND COHORT Currently enrolling in primary regimen at 6mg/kg cohort
Key Eligibility Criteria:
• ECOG of 0-1 • Subjects must have failed at least two prior systemic regimens and still require therapy • Eligible histologies are as follows: o Primary cutaneous gamma-delta T-cell lymphoma o Primary cutaneous CD8+ aggressive epidermotropic cytotoxic T-cell lymphoma o Hepatosplenic T-cell lymphoma o Subcutaneous panniculitis-like T-cell lymphoma (almost always ab disease) o Aggressive NK-cell leukemia o Systemic Epstein-Barr virus (EBV)1 T-cell lymphoma, if CD8 positive o Hydroa vacciniforme-like lymphoproliferative disorder o Extranodal NK-/T-cell lymphoma, nasal type o Enteropathy-associated T-cell lymphoma o Monomorphic epitheliotropic intestinal T-cell lymphoma o Indolent (CD8+ or NK derived) of the gastrointestinal (GI) tract o Other CD8+/NK cell driven lymphoma not listed above
Laboratory Value
• Prothrombin time or international normalized ratio (INR) ≤1.5 × upper limit of normal (ULN). • Activated partial thromboplastin time ≤1.5 × ULN. • Creatinine clearance (CrCl) ≥50 mL/min (using Cockcroft-Gault • Total bilirubin ≤1.5 × ULN (≤3 × ULN if known Gilbert's disease). • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN (≤5 × ULN if malignant involvement of the liver and approval by the medical monitor • Amylase < 1.5 × ULN
Exclusion Criteria • < 750/mm3 neutrophils • < 50,000/mm3 thrombocytes • Active systemic infection requiring systemic antibiotics, antivirals or antifungals. • Active or suspected malignant central nervous system involvement. • Life-threatening, severe complications of malignancy • Active known second malignancy • Hemophagocytic lymphohistiocytosis (HLH) • Electrocardiogram (ECG) QT interval corrected for heart rate (QTc) >475 msec • History of clinically significant cardiac disease or congestive heart failure • Autologous HSCT within 40 days of C1D1, allogeneic HSCT within 90 days • Any immunosuppressive therapy for GVHD for subjects who are post allogeneic HSCT.
PI: Iyer, Swaminathan Contact: Anita Aickareth Phone: (713) 563-8732
NORM: Nodular Lymphocyte-predominant Hodgkin Lymphoma Patients Treated in a Randomized Phase 2 Trial with Either Rituximab or Mosunetuzumab
Protocol Number: 2022-1065 Slots available for cHL: 62 out of 70 Key Information:
Key Inclusions: - Untreated NLPHL: Stage IB to IV according to Cotswolds - Previously treated NLPHL, any stage - Must have measurable disease. - ECOG ≤2 - Human immunodeficiency virus-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
Key Exclusions: - cHL or composite lymphoma - Transformed NLPHL, concerns of the treating physician of an occult transformation or concerns of the treating physician that the patient needs cytotoxic therapy - Patients with CNS involvement - Prior allogeneic stem cell or solid organ transplantation - Systemic immunosuppressive medications within 2 weeks - Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
PI: Chihara, Dai Contact: Nunmaker, Amanda
Phone: 346-725-2997
An Open-Label, Phase 2 Trial of Nanatinostat in Combination with Valganciclovir in Patients with Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas (NAVAL-1)
Protocol Number: 2021-0463 Slots available for cHL: 10 slots open Key Information:
1.EBV+ diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) 2. Extranodal NK/T-cell lymphoma (ENKTL) 3. Peripheral T-cell lymphoma (PTCL), including PTCL-NOS and angioimmunoblastic T-cell lymphoma (AITL): • 3a: Nanatinostat monotherapy • 3b: Nanatinostat + valganciclovir 4. Hodgkin lymphoma (HL) 5. Post-transplant lymphoproliferative disorder (PTLD) 6. Lymphomas associated with human immunodeficiency virus (HIV) infection (HIV-L): Plasmablastic, Burkitt, Hodgkin and DLBCL 7. EBV+ lymphomas other than the above PI: Nair, Ranjit Contact: Jenna Wixom Phone: (713) 416-3951
Protocol Key Eligibility Requirements for: 2021-0463
Protocol Abstract for 2021-0463
PET adapted Brentuximab Vedotin and Pembrolizumab in Combination with Doxorubicin and Dacarbazine in Classic Hodgkin Lymphoma
Protocol Number: 2022-0492 Slots available for cHL: 25 slot open
Key Information:
Treatment-naïve
HL subjects with Ann Arbor stage III, IV, or stage II with bulky disease (>10cm). 5 days in patient at the beginning of each cycle. 6 cycles.
PI: Lee, Hun Contact: Dr. Jenna Wixom Phone: 713-416-3951
A Phase I/II Open-Label, Multi-center Study to Assess Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD7789, and anti-PD-1 and anti-TIM-3 Bispecific Antibody, in Patients with RR cHL
Protocol Number: 2021-1130 Slots available for cHL: 30 OUT OF 30 CNPE until new cohort is open.
Key Information:
relapsed/refractory classical Hodgkin Lymphoma ECOG ≤1 Failed at least 2 LOT Had at least 3 cycles of prior anti PD-1/PD-L1 PI: Lee, Hun Contact: Dr. Lee, Hun Phone: 713-794-1829 Email: hunlee@mdanderson.org
Protocol Key Eligibility Requirements for 2021-1130
Protocol Summary for 2021-1130 A Phase 1 Safety and Efficacy Study of ADI-001 Anti-CD20 CAR-engineered Allogeneic Gamma Delta (γδ) T Cells in Adults with B Cell Malignancies, in Monotherapy and Combination with IL-2
Protocol Number: 2020-1137 Slots available for MZL:
1
Key Information:
2 prior lines of systemic therapy, including an anthracycline or alkylator and at least 1 BTK inhibitor and anti-CD20 monoclonal antibody. PI:
Neelapu, Sattva
Contact:
Johncy, Swapna
Phone:
(713) 792-8251
Protocol Key Eligibility Requirements for: 2020-1137 Inclusion Patients with R/R B cell malignancies including DLBCL,HGBCL,MCL,FL,MZL, PMBCL, Burkitts Lymphoma. Prior therapies:MCL - 2 prior lines of systemic therapy, including an anthracycline or alkylator and at least 1 BTK inhibitor and anti-CD20 monoclonal antibody. Large B cell lymphomas including DLBCL, HGBCL, tFL, and PMBCL- 2 prior lines of therapy, including an anthracycline and anti-CD20 monoclonal antibody therapy. FL and MZL- 2 prior lines of systemic therapy, including an alkylator and an anti-CD20 monoclonal antibody therapy. Monotherapy with anti CD20 monoclonal antibody will not be considered as a line of therapy. Exclusion CNS Involvement ASCT within 45 days of screening
Known CD20 negative tumor Active uncontrolled fungal, bacterial, viral, protozoal, or other infection.
Any form of primary immunodeficiency (e.g., severe combined immunodeficiency disease). History of human immunodeficiency virus (HIV) infection. Active hepatitis B or hepatitis C.
Protocol Summary for 2020-1137
A Phase 3 Randomized, Open-Label, Multicenter Study of Zanubrutinib (BGB-3111) Plus Anti-CD20 Antibodies Versus Lenalidomide Plus Rituximab in Patients With Relapsed/Refractory Follicular or Marginal Zone Lymphoma Protocol Number: 2023-0335 Slots available for MZL: Open
Key Information:
Previously treated with 1+ prior line systemic therapy. Previously treated with 1+ prior line systemic therapy.
PI: Nastoupil, Loretta Contact: Lauren Wynn Phone: 346-722-0275 Email: lrwynn@mdanderson.org
Protocol Summary for 2023-0335
A Phase I/II Open Label, Single Center, Study of the Combination of ALX148, Rituximab and Lenalidomide in Patients with Indolent and Aggressive B-cell Non-Hodgkin Lymphoma
Protocol Number: 2021-0226 Slots available for MZL: 24 OUT OF 24 Key Information: Phase II: no prior systemic treatment, high tumor burden disease, Stage III or IV, ECOG 0-1
PI: Strati, Paolo Contact: Davidson, Jeffry Phone: (713) 745-5095 Pager:
Protocol Key Eligibility Requirements for: 2021-0226
Protocol Fact Sheet for: 2021-0226
A Phase 2, Open-label, Multicenter Study of the Safety and Efficacy of TAK-007 in Adult Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Protocol Number: 2021-0583 Slots available for MZL: 1 of 1 Slot
Key Information:
Study drug: TAK-007 (cryopreserved cord blood NK CAR).
TAK-007 is a cryopreserved cord blood NK CAR
Accepts R/R large B-cell lymphoma subtypes, FL gr 1-3b, and MZL after 2 lines of systemic therapy
PI: Strati, Paolo Contact: Laurel Deaton Phone: fldeaton@mdanderson.org
Protocol Eligibility Requirements for 2021-0583 Major Inclusion Criteria: 1. R/R refractory CD19 expressing disease after at least 2 lines of therapy: a. LBCL, including subtypes defined by the WHO and FL gr 3b. (must have prior anti-CD20 mAb and an anthracycline containing chemotherapy regimen and failed or be ineligible for high-dose chemotherapy and ASCT) b. FL and MZL (must have prior anti-CD20 mAb and an alkylating agent) 2. ECOG 0 or 1 3. ANC >500; plts >50; eGFR ≥30 mL/min 4. LVEF ≥40% 5. No evidence of clinically relevant pericardial effusion, and no acute clinically significant ECG findings. 6. Absence of Grade ≥2 pleural effusion. Baseline O2 sat >92% on RA
Major Exclusion Criteria: 1. CNS lymphoma, BL, MCL, LPL, or Richter's 2. Hx of anti-CD19 therapy 3. Hx of malignancy other than nonmelanoma skin cancer, carcinoma in situ, low-grade tumors deemed to be cured and not treated with systemic therapy unless disease free for ≥3 years 4. Auto or allo SCT within 3 months 5. Active infection. 6. Active HIV, HBV, HCV, or Covid-19 infection at screening 7. Clinically relevant CNS disorder 8. Clinically significant cardiac condition within 12 months 9. DVT or PE within 6 months 10. Hx of autoimmune disease or solid organ transplantation, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years.
Protocol Summary for 2021-0583
A Phase 1/2 Open-label, Multicenter Study Evaluating the Safety and Efficacy of KITE-363, an Autologous Anti-CD19/CD20 CAR T-cell Therapy, in Subjects With Relapsed and/or Refractory B-cell Lymphoma
Protocol Number: 2020-1136 Slots available for MZL: 1 OUT OF 10
Key Information:
Currently in dose escalation phase, slots are staggered . PI: Loretta Nastoupil Contact: Ly, Dsouza Phone: (832)-817-8154
Protocol Eligibility Requirements for 2020-1136 Inclusion:
Exclusion:
Protocol Summary for 2020-1136
A Phase 1, Multicenter, Open-Label Study of CB-010, a CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy in Patients with Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma Protocol Number: 2020-1041
Slots available for MZL:
5 OUT OF 5
Key Information:
Phase 1 study of CB-010, a CRISPR-edited allogeneic anti-CD19 CAR-T cell therapy in R/R B-cell NHL (DLBCL, tFL, PMBCL, HGBCL, MCL, FL, and MZL) PI:
Nastoupil, Loretta
Contact:
Dsouza, Ly
Phone:
832-817-8154
Protocol Eligibility Requirements for 2020-1041
Inclusion: DLBCL, HGBL, tFL, PMBCL Prior therapy must include anti-CD20 Ab and anthracycline and 1 or more of the following: Primary refractory diseaseNo response to second or more lines of therapy Refractory post ASCT FL or MZL Failed an anti-CD20 Ab and alkylating agent Best response to most recent therapy was PD MCL Failed anti-CD20 Ab, alkylating agent, and BTKi ECOG of 0 or 1 Oxygen saturation > 92% on room air with ≤ Grade 1 dyspnea Cardiac ejection fraction > 50% and no evidence of pericardial effusion or clinically significant ECG findings Laboratory parameters as follows: Serum albumin ≥ 3.0 g/dL; ALT/AST ≤ 2.5 × ULN; ANC ≥ 1000/uL; Platelet count ≥ 75,000/uL; Serum creatinine ≤ 1.5 × ULN, or calculated creatine clearance > 60 mL/min by Cockcroft Gault formula or estimated glomerular filtration rate > 60 mL/min/1.73 m2; Total bilirubin ≤ 1.5 mg/dL
Exclusion: History of prior therapy with an anti-CD19 targeting agent Active acute or chronic GvHD requiring therapy History of allogeneic stem cell transplantation ASCT within 8 weeks of informed consent Clinically significant CNS dysfunction or disease. Current thyroid disorder (including hyperthyroidism). Hypothyroidism controlled with a stable dose of hormone replacement therapy is permitted History of HIV. Active hepatitis B or C virus infection. Requirement for urgent therapy because of tumor mass effects such as bowel obstruction or blood vessel compression Presence of pleural, peritoneal or pericardial catheter Clinically significant pleural effusion History of significant cardiac disease within 12 months of enrollment Concurrent or previous other malignancy within 2 years of study entry, except curatively treated malignancies. History of autoimmune disease resulting in end organ injury or requiring within the last 2 years systemic immunosuppressive or disease modifying agents
Protocol Summary for 2020-1041
A Phase II Study of Acalabrutinib, Lenalidomide and Rituximab (aR2) in Patients with Previously Untreated Follicular Lymphoma
Protocol Number: 2020-0034 Slots available for MZL: 0 OUT OF 10 Key Information:
Revlimid & Rituximab billed to INS; Acalabrutinib provided by sponsor. Bi-dimensionally measurable disease, with at least one nodal lesion >/= 1.5 cm instead of >/= 2.0cm
PI: Strati, Paolo Contact: Lisa Hitchcock-Weber Phone: 713-492-3044 Email: LMHitchcock@mdanderson.org
Protocol Key Eligibility Requirements for: 2020-0034 Inclusion:
Histologically confirmed CD20+ follicular lymphoma, grade 1, 2, or 3a Have had no prior systemic treatment for lymphoma Bi-dimensionally measurable disease, with at least one mass lesion ≥ 1.5 cm in longest diameter by CT, PET/CT, and/or MRI. High tumor burden disease, defined by meeting 1 or more GELF criteria Stage III or IV disease Exclusion:
Known active CNS lymphoma or leptomeningeal disease, except subjects with a history of central nervous system lymphoma treated and in remission > 6 months. Evidence of diffuse large B-cell transformation Grade 3b FL Any prior history of other malignancy besides FL or marginal zone lymphoma, unless the patient has been free of disease for ≥ 5 years and felt to be at low risk for recurrence by the treating physician
Protocol Fact Sheet for: 2020-0034
A Phase 1, First-in-Human, Dose Escalation Study of the JNJ-75348780 Bispecific Antibody Targeting CD3 and CD22 in Participants with NHL and CLL
Protocol Number: 2021-0203 Slots available for MZL: 0 OUT OF 10 Key Information: Patients with R/R B-cell NHL DLBCL: received or not eligible for high-dose chemotherapy and autologous stem cell transplantation with curative intent. FL/MZL (except MALT) or WM: Previously treated with at least 1 prior line of systemic therapy containing an anti-CD20 antibody. MCL: Previously treated with at least 2 prior line of systemic therapy containing an anti-CD20 antibody. Patients with CLL or SLL: R/R with at least one prior line of systemic therapy containing a BTK inhibitor. ECOG 0-1 Adequate lab parameters without transfusion for at least 7 days prior to first dose of study drug
PI: Chihara, Dai Contact: Amanda Nunmaker Phone: 346-725-2997 Email: AMnunmaker@mdanderson.org
A Phase 1/2, First in Human, Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Triple-specific T-cell Engager 1A46 in Adult Patients with Advanced CD20 and/or CD19 Positive B-cell Hematologic Malignancies
Protocol Number: 2021-1214 Slots available for MZL: 1 out of 1
Key Information:
1A46 is a tri-specific T-cell activating antibody that binds to human CD3, CD19 and CD20. Infusions are weekly for the first 8 cycles (24 weeks) and then once q3 weeks for the next 8 cycles. Patients will be hospitalized for 72 hours following each new dose level (3 total dose levels); subsequent doses may be outpatient. Trial is in dose escalation phase. PI: Ahmed, Sairah Contact: lcebarle@mdanderson.org Phone:
Protocol Fact Sheet for 2021-1214
AN OPEN-LABEL, PHASE I STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS AND PRELIMINARY ANTITUMOR ACTIVITY OF RO7227166 (A CD19 TARGETED 4-1BB LIGAND) IN COMBINATION WITH OBINUTUZUMAB AND IN COMBINATION WITH GLOFITAMAB FOLLOWING A PRETREATMENT DOSE OF OBINUTUZUMAB ADMINISTERED IN PARTICIPANTS WITH RELAPSED/REFRACTORY B-CELL NON-HODGKIN'S LYMPHOMA
Protocol Number: 2022-0602 Slots available for DLBCL: CNPE until July 2024
Key Information:
Measurable lesion >/= 1.5cm R/R/ DLBCL Mandatory Hospitalization Hgb >10, plt >75k PI: Westin, Jason Contact: Awolowo, Kemi Phone: 346-725-1414
Email: orawolowo@mdanderson.org
Pending ranking for MZL (listed top until updated)
A RANDOMIZED, OPEN-LABEL, MULTICENTER PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF MOSUNETUZUMAB IN COMBINATION WITH POLATUZUMAB VEDOTIN IN COMPARISON WITH RITUXIMAB IN COMBINATION WITH GEMCITABINE PLUS OXALIPLATIN IN PARTICIPANTS WITH RELAPSED OR REFRACTORY AGGRESSIVE B-CELL NON-HODGKIN'S LYMPHOMA
Protocol Number: 2023-0274 Slots available for DLBCL: 10 Slot available
Key Information:
PS 0-2 Prior line >/= 1 Ineligible for ASCT Measurable disease > 1.5 cm Platelet count >/= 75 Hgb >/= 9 g/dL Histologies: DLBCL CD20, CD79b
PI: Westin, Jason Contact: Awolowo, Kemi Phone: 346-725-1414
Email: orawolowo@mdanderson.org
Pending ranking for MZL (listed top until updated)
A PHASE IB, OPEN-LABEL, MULTICENTER, SINGLE ARM STUDY EVALUATING THE PRELIMINARY EFFICACY, SAFETY, AND PHARMACOKINETICS OF GLOFITAMAB IN COMBINATION WITH RITUXIMAB PLUS IFOSFAMIDE, CARBOPLATIN ETOPOSIDE PHOSPHATE IN PATIENTS WITH RELAPSED/REFRACTORY TRANSPLANT ELIGIBLE DIFFUSE B-CELL LYMPHOMA
Protocol Number: 2022-0661 Slots available for DLBCL: 15 slots out of 15
Key Information:
Histologically confirmed B-cell lymphoma, DLBCL, HGBCL PI: Fayad, Luis Contact: Player Danika Phone: 713-563-1725
Email: djscott@mdanderson.org
Pending ranking for MZL (listed top until updated)
A Phase II trial of Mosunetuzumab, Polatuzumab, Tafasitamab, and Lenalidomide in Patients with Relapsed B-cell NHL
Protocol Number: 2022-0459 Slots available for DLBCL: 36 of 36
Key Information: Relapsed CD20+ DLBCL . Evidence of progression or lack of response following at least 1 prior treatment
Major inclusion: -Diagnosis of relapsed CD20+ DLBCL -Evidence of progression or lack of response following at least 1 prior treatment -Hemoglobin ≥ 9.0 g/dL, ANC ≥ 1.0 x 10^9/L , Platelet count ≥ 75 x 10 ^9/L -CrCl: ≥ 30ml/min by Cockcroft-Gault formula.
Major Exclusion Criteria: -Prior systemic treatment 4 weeks prior to C1D1. -Prior treatment with Polatuzumab Vedotin, Mosunetuzumab or other CD20-directed bispecific antibodies, tafasitamab, lenalidomide -Autologous SCT within 100 days prior to C1D1 -Prior treatment with CAR-T therapy within 30 days prior to C1D1 -Current eligibility for autologous SCT in patients with R/R DLBCL -Prior allogeneic SCT
PI: Westin, Jason Contact: Tom Jisha Phone: 713-592-2311
Email: jmathews2@mdanderson.org
Pending ranking for MZL (listed top until updated)
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Protocol Abstract for: 2019-0615
CG-806 (Pan-FLT3/BTK Multi-Kinase Inhibitor) for R/R CLL/SLL & NHL
Protocol Number: 2019-0313 Slots available for MZL: 15 OUT OF 18 5/5/22 Open for enrollment
Study is on temporary enrollment hold to complete data collection for G3 substudy as all slots have been filled.
No longer requires 2 or more prior lines of therapy, allows for one or more lines of therapy for all subtypes of NHL and CLL. G3 study has 2 slots available for the 200mg slot and cohort 6 is filled but may consider additional patients.
Key Information:
No longer requires 2 or more prior therapies. Only requires one or more prior therapies. ECOG < /= 2 NHL pt must have measurable disease of 1.5cm or greater CLL must have clonal population of lymphocytes in their blood and lymphocytosis > 5 x 10^9cells/L or hepatomegaly or splenomegaly consistent with disease infiltration Prior use of iburutinib allowed enrollment currently on hold and waiting on amendment 7 approval for new formulation. PI: Samaniego, Felipe Contact: Ramos, Jennifer Phone: (713) 563-5426
Protocol Key Eligibility Requirements for 2019-0313
Inclusion: Pathologically documented relapsed or refractory B cell NHL or CLL/SLL who have failed or are intolerant to 2 or more lines of established therapy, or for whom no other treatment options are available in the opinion of the investigator. - Resistance is defined as having failed to achieve a CR or PR with the most recent line of therapy Patients with FL, MZL and WM must require systemic therapy. All patients must have measurable disease. For NHL patients, tumor masses these must be bidimensionally measurable by physical examination, (CT, MRI or PET-CT. When measurable disease consists of peripheral lymph nodes, the target lymph nodes must be >/=1.5 cm in longest diameter. Patients with CLL must have a clonal population of lymphocytes in their blood and a lymphocytotosis of> 5 x 1 0J\9 cells/L. Patients with WM must have a monoclonal immunoglobin identifiable with SPEP whose concentration is elevated above normal limits. Prior use of ibrutinib or other covalent or non-covalent BTK inhibitor is allowed; the patient is eligible even after failing ibrutinib or other covalent or non-covalent BTK inhibitor due to lack of response or adverse events including atrial fibrillation. Patients who have had prior Auto or Allo SCT are eligible as long as they are >90 days post-transplant and do not require systemic immunosuppressive treatment for GVHD. Patients may have received prior radiation but must be >21 days since the last dose of external beam radiation therapy. Life expectancy of at least 2 months ECOG < /= 2 Cardiovascular parameters that must be met within 28 days of study treatment: - QTcF < /=450 msec for males, QTcF < /=470 msec for females Hematologic parameters that must be met within 28 days of study treatment: - ANC>/= 1,000 cells/µL - Platelet count>/= 50,000 cells/µL - If neutropenia or thrombocytopenia is believed to be due to marrow infiltration with malignant cells then there are no lower limits for the absolute neutrophil or platelet count for initiation or re-initiation of study drug retreatment. - INR/PT and aPTT < /=1.5 times ULN Renal & Liver function parameters that must be met within 28 days of study treatment: -All patients must have a CrCl >/= 60 ml/min, Adequate liver function tests (LFT): Total and direct bilirubin < /= 1.5 x the institutional ULN; AL T/AST < /= 2.5 x ULN Exclusion Criteria: Receipt of cytotoxic therapy within the preceding 14 days, or within 5 half-lives for prior noncytotoxic agents, prior to first study treatment administration Unresolved clinically significant toxicities of Grade 2 or higher from prior therapies Treatment with other investigational drugs within 14 days prior to first study treatment administration Patients with GVHD requiring systemic immunosuppressive therapy Patients with a known bleeding diathesis including anti-coagulation with any form of anticoagulant, coagulation factor deficiency, coagulopathy, prior major bleeding episode unrelated to surgery or trauma or stroke. Patients with another active malignancy requiring systemic therapy Leptomeningeal or CNS disease Uncontrolled auto-immune hemolytic anemia Major surgery < /= 14 days prior to signature of ICF and no minor surgery < /= 3 days prior to signature of ICF (with the exception of intravenous (IV) access placement, e.g. Hickman or PICC). Uncontrolled serious illness or medical conditions, which in the Investigator's opinion could hamper understanding of the study by the patient, patient's compliance to study treatment, patient's safety, or interpretation of study results. Need to concurrently take drugs that are substrates or known moderate or strong inhibitors of CYP2C8, CYP2C9, and CYP3A4/5 and drugs associated with a high risk of QT prolongation and torsades de pointes
Protocol Summary for 2019-0313
Protocol Abstract for 2019-0313
Ultra Low Dose 4 Gy Orbital Radiation for Definitive Therapy of Indolent B Cell Lymphoma
Protocol Number: 2014-1046 Slots available for MZL: 1 OUT OF 53 Key Information: *RadOnc Study* 4 Gy of radiation usually in 2 treatments (boom-boom) to either or both orbits as determined by treating radiation oncologist. 4-week washout period for prior systemic treatment. PI: Pinnix, Chelsea
Contact: Garza, Sabina
Phone: (713) 563-3628
Pager: (713) 404-2213
Protocol Eligibility Requirements for 2014-1046
Indolent B-cell lymphoma-inc. follicular & MALT, mantle cell, no CLL/SLL Biopsy-proven measureable disease Systemic therapy allowed, but not within 4 weeks prior to enrollment Exclude if prior radiation treatment exceeds dosing tolerance
Protocol Summary for 2014-1046
Please Note: there is no fact sheet because this is a radiation-only study.
Protocol Abstract for 2014-1046
Ultra Low Dose 4 Gy Orbital Radiation for Definitive Therapy of Indolent B Cell Lymphoma
Protocol Number: 2014-1046 Slots available for MZL: 1 OUT OF 53 Key Information: *RadOnc Study* 4 Gy of radiation usually in 2 treatments (boom-boom) to either or both orbits as determined by treating radiation oncologist. 4-week washout period for prior systemic treatment. PI: Pinnix, Chelsea
Contact: Garza, Sabrina
Phone: (713) 563-3628
Pager: (713) 404-2213
Protocol Eligibility Requirements for 2014-1046
Indolent B-cell lymphoma-inc. follicular & MALT, mantle cell, no CLL/SLL Biopsy-proven measureable disease Systemic therapy allowed, but not within 4 weeks prior to enrollment Exclude if prior radiation treatment exceeds dosing tolerance
Protocol Summary for 2014-1046
Please Note: there is no fact sheet because this is a radiation-only study.
Protocol Abstract for 2014-1046
A Phase 1, First-in-Human, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-67856633, an Inhibitor of MALT1, in Participants With NHL and CLL
Protocol Number: 2020-0452 Slots available for SLL: 15 OUT OF 15 CNPE
Protocol is terminated.
Key Information:
ECOG of 0-1 Labs: Hgb ≥8 g/dL, Plt ≥75×109/L, ANC ≥1.0×109/L, AST, ALT, GGT, and alkaline phosphatase ≤2.5× ULN, Serum total bilirubin ≤1.5× ULN, calculated or measured creatinine clearance ≥40 mL/min. Exclusion: Known active CNS involvement, prior solid organ transplant, active autoimmune disease requiring systemic immunosuppressive meds and active or chronic Hep B, C, HIV infection. PI: Samaniego, Felipe Contact: jennramos@mdanderson.org Phone: 713-563-5426
Protocol Eligibility Requirements for 2020-0452 Inclusion: ECOG of 0-1 Hgb ≥8 g/dL, Plt ≥75×109/L, ANC ≥1.0×109/L, AST, ALT, GGT, and alkaline phosphatase ≤2.5× ULN, Serum total bilirubin ≤1.5× ULN, calculated or measured creatinine clearance ≥40 mL/min. Exclusion: Known active CNS involvement prior solid organ transplant active autoimmune disease requiring systemic immunosuppressive meds active or chronic Hep B, C, HIV infection
Protocol Summary for 2020-0452
CG-806 (Pan-FLT3/BTK Multi-Kinase Inhibitor) for R/R CLL/SLL & NHL
Protocol Number: 2019-0313 Slots available for SLL: 15 OUT OF 18 5/5/22 Open for enrollment
Study is on temporary enrollment hold to complete data collection for G3 substudy as all slots have been filled.
No longer requires 2 or more prior lines of therapy, allows for one or more lines of therapy for all subtypes of NHL and CLL. G3 study has 2 slots available for the 200mg slot and cohort 6 is filled but may consider additional patients.
Key Information:
No longer requires 2 or more prior therapies. Only requires one or more prior therapies. ECOG < /= 2 NHL pt must have measurable disease of 1.5cm or greater CLL must have clonal population of lymphocytes in their blood and lymphocytosis > 5 x 10^9cells/L or hepatomegaly or splenomegaly consistent with disease infiltration Prior use of iburutinib allowed enrollment currently on hold and waiting on amendment 7 approval for new formulation. PI: Samaniego, Felipe Contact: Ramos, Jennifer Phone: (713) 563-5426
Protocol Key Eligibility Requirements for 2019-0313
Inclusion: Pathologically documented relapsed or refractory B cell NHL or CLL/SLL who have failed or are intolerant to 2 or more lines of established therapy, or for whom no other treatment options are available in the opinion of the investigator. - Resistance is defined as having failed to achieve a CR or PR with the most recent line of therapy Patients with FL, MZL and WM must require systemic therapy. All patients must have measurable disease. For NHL patients, tumor masses these must be bidimensionally measurable by physical examination, (CT, MRI or PET-CT. When measurable disease consists of peripheral lymph nodes, the target lymph nodes must be >/=1.5 cm in longest diameter. Patients with CLL must have a clonal population of lymphocytes in their blood and a lymphocytotosis of> 5 x 1 0J\9 cells/L. Patients with WM must have a monoclonal immunoglobin identifiable with SPEP whose concentration is elevated above normal limits. Prior use of ibrutinib or other covalent or non-covalent BTK inhibitor is allowed; the patient is eligible even after failing ibrutinib or other covalent or non-covalent BTK inhibitor due to lack of response or adverse events including atrial fibrillation. Patients who have had prior Auto or Allo SCT are eligible as long as they are >90 days post-transplant and do not require systemic immunosuppressive treatment for GVHD. Patients may have received prior radiation but must be >21 days since the last dose of external beam radiation therapy. Life expectancy of at least 2 months ECOG < /= 2 Cardiovascular parameters that must be met within 28 days of study treatment: - QTcF < /=450 msec for males, QTcF < /=470 msec for females Hematologic parameters that must be met within 28 days of study treatment: - ANC>/= 1,000 cells/µL - Platelet count>/= 50,000 cells/µL - If neutropenia or thrombocytopenia is believed to be due to marrow infiltration with malignant cells then there are no lower limits for the absolute neutrophil or platelet count for initiation or re-initiation of study drug retreatment. - INR/PT and aPTT < /=1.5 times ULN Renal & Liver function parameters that must be met within 28 days of study treatment: -All patients must have a CrCl >/= 60 ml/min, Adequate liver function tests (LFT): Total and direct bilirubin < /= 1.5 x the institutional ULN; AL T/AST < /= 2.5 x ULN Exclusion Criteria: Receipt of cytotoxic therapy within the preceding 14 days, or within 5 half-lives for prior noncytotoxic agents, prior to first study treatment administration Unresolved clinically significant toxicities of Grade 2 or higher from prior therapies Treatment with other investigational drugs within 14 days prior to first study treatment administration Patients with GVHD requiring systemic immunosuppressive therapy Patients with a known bleeding diathesis including anti-coagulation with any form of anticoagulant, coagulation factor deficiency, coagulopathy, prior major bleeding episode unrelated to surgery or trauma or stroke. Patients with another active malignancy requiring systemic therapy Leptomeningeal or CNS disease Uncontrolled auto-immune hemolytic anemia Major surgery < /= 14 days prior to signature of ICF and no minor surgery < /= 3 days prior to signature of ICF (with the exception of intravenous (IV) access placement, e.g. Hickman or PICC). Uncontrolled serious illness or medical conditions, which in the Investigator's opinion could hamper understanding of the study by the patient, patient's compliance to study treatment, patient's safety, or interpretation of study results. Need to concurrently take drugs that are substrates or known moderate or strong inhibitors of CYP2C8, CYP2C9, and CYP3A4/5 and drugs associated with a high risk of QT prolongation and torsades de pointes
Protocol Abstract for 2019-0313
Protocol Summary for 2019-0313
A Phase 1, First-in-Human, Dose Escalation Study of the JNJ-75348780 Bispecific Antibody Targeting CD3 and CD22 in Participants with NHL and CLL
Protocol Number: 2021-0203 Slots available for SLL/CLL: 0 OUT OF 10 Key Information:MCL: : Patients with R/R B-cell NHL DLBCL: received or not eligible for high-dose chemotherapy and autologous stem cell transplantation with curative intent. FL/MZL (except MALT) or WM: Previously treated with at least 1 prior line of systemic therapy containing an anti-CD20 antibody. MCL: Previously treated with at least 1 prior line of systemic therapy containing an anti-CD20 antibody. Patients with CLL or SLL: R/R with at least one prior line of systemic therapy containing a BTK inhibitor. ECOG 0-1 Adequate lab parameters without transfusion for at least 7 days prior to first dose of study drug
PI: Chihara, Dai Contact: Amanda Nunmaker Phone: 346-725-2997 Email: AMnunmaker@mdanderson.org
A Phase II trial of Rituximab, Lenalidomide, Acalabrutinib, Tafasitamab prior to and with standard chemotherapy for patients with newly diagnosed DLBCL (Smart Stop)
Protocol Number: 2021-0046 Slots available for DLBCL: Total 60 slots, Group1 ARM A&B 30 slots; Group2 ARM C&D 30 slots
Key Information:
Only DLBCL No Prior Treatment No Randomization Only one arm will be active at one time. PI: Westin, Jason Contact: Jisha Tom Email: JMathews2@mdanderson.org
Eligibility Requirements for 2021-0046 Inclusion:
Exclusion:
Protocol Fact Sheet for 2021-0046
A phase Ib, multi-center, open-label dose escalation and expansion platform study of VAY736 as single agent and in combination with select antineoplastic agents in patients with non-Hodgkin Lymphoma (NHL)
Protocol Number: 2021-1001 Slots available for DLBCL: CNPE
Key Information:
1) Need sponsor slot approval prior to consenting 2) At least two prior lines, including an anti-CD20 therapy, but no more than 5 prior lines. 3) Must have measurable disease and ECOG ≤2 4) Must have a site of disease amenable to biopsy
PI: Westin, Jason Contact: Shivon Mathew Email: samathew1@mdanderson.org
Eligibility Requirements for 2021-1001 Inclusion:
Exclusion:
A Phase II Study of Loncastuximab Tesirine as Consolidation Strategy in Patients with Large B-cell Lymphoma who Achieve Partial Remission After CAR T-cell Therapy
Protocol Number: 2022-0147 Slots available for DLBCL: 30 out of 30
Key Information:
Aggressive/Large Cell (Burkitts/DLBCL) Loncastuximab Tesirine as Consolidation Strategy in Patients with Large B-cell Lymphoma who Achieve Partial Response After SOC CAR T-cell Therapy PI: Strati, Paolo Contact: Lara Ebarle Email: lcebarle@mdanderson.org
Pending ranking for FL (listed top until updated)
Protocol Summary for 2022-0147
A Phase 1/2, First in Human, Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Triple-specific T-cell Engager 1A46 in Adult Patients with Advanced CD20 and/or CD19 Positive B-cell Hematologic Malignancies
Protocol Number: 2021-1214 Slots available for DLBCL: 1 out of 1
Key Information:
1A46 is a tri-specific T-cell activating antibody that binds to human CD3, CD19 and CD20. Infusions are weekly for the first 8 cycles (24 weeks) and then once q3 weeks for the next 8 cycles. Patients will be hospitalized for 72 hours following each new dose level (3 total dose levels); subsequent doses may be outpatient. Trial is in dose escalation phase. PI: Ahmed, Sairah Contact: lcebarle@mdanderson.org Phone:
Protocol Fact Sheet for 2021-1214
A Phase 1b Multicenter, Open-label, Study of JNJ-90009530, an Autologous Anti-CD20 CAR-T Cell Therapy in Adult Participants with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Protocol Number: 2023-0706 Slots available for DLBCL: 5 out of 5
Key Information:
Study Treatment: Study drug is JNJ90009530, CD20 directed, autologous CAR-T Conditioning chemotherapy with Fludarabine/Cyclophosphamide Bridging allowed (if needed) following apheresis Key Inclusion: CD20 positive disease R/R disease after at least 2 lines of standard therapy, with measurable disease per Lugano criteria ECOG 0-1 CrCl > 50 mL/min Hgb > 8, ANC > 1, ALC > 0.3, Plt > 50,000 LVEF > 45% Key Exclusion: Active CNS disease (history of treated CNS disease allowed) HHV8+ DLBCL, Burkitt's Previous allogeneic transplant History of stroke, MI, CHF, DVT, PE within 6 months of screening PI: Ahmed, Sairah Contact: releonard@mdanderson.org Phone:
Phase 1, Open-Label Study of Autologous SIRPα-low Macrophages (SIRPant- M) Administered by Intratumoral Injection Alone or in Combination with Focal External-Beam Radiotherapy in Participants with Relapsed or Refractory Non- Hodgkin's Lymphoma
Protocol Number: 2023-0610 Slots available for DLBCL: 6 of 6 Slot
Key Information:
PI: Strati, Paolo Contact: Laurel Deaton Phone: fldeaton@mdanderson.org
Phase 1, Open-Label Study of Autologous SIRPα-low Macrophages (SIRPant- M) Administered by Intratumoral Injection Alone or in Combination with Focal External-Beam Radiotherapy in Participants with Relapsed or Refractory Non- Hodgkin's Lymphoma
Protocol Number: 2023-0610 Slots available for MCL: 6 of 6 Slot
Key Information:
PI: Strati, Paolo Contact: Laurel Deaton Phone: fldeaton@mdanderson.org
Phase 1, Open-Label Study of Autologous SIRPα-low Macrophages (SIRPant- M) Administered by Intratumoral Injection Alone or in Combination with Focal External-Beam Radiotherapy in Participants with Relapsed or Refractory Non- Hodgkin's Lymphoma
Protocol Number: 2023-0610 Slots available for MZL: 6 of 6 Slot
Key Information:
PI: Strati, Paolo Contact: Laurel Deaton Phone: fldeaton@mdanderson.org
Phase 1, Open-Label Study of Autologous SIRPα-low Macrophages (SIRPant- M) Administered by Intratumoral Injection Alone or in Combination with Focal External-Beam Radiotherapy in Participants with Relapsed or Refractory Non- Hodgkin's Lymphoma
Protocol Number: 2023-0610 Slots available for SLL/CLL: 6 of 6 Slot
Key Information:
PI: Strati, Paolo Contact: Laurel Deaton Phone: fldeaton@mdanderson.org
Phase 1, Open-Label Study of Autologous SIRPα-low Macrophages (SIRPant- M) Administered by Intratumoral Injection Alone or in Combination with Focal External-Beam Radiotherapy in Participants with Relapsed or Refractory Non- Hodgkin's Lymphoma
Protocol Number: 2023-0610 Slots available for T-Cell: 6 of 6 Slot
Key Information:
PI: Strati, Paolo Contact: Laurel Deaton Phone: fldeaton@mdanderson.org
A Phase 2, Open-label, Multicenter Study of the Safety and Efficacy of TAK-007 in Adult Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Protocol Number: 2021-0583 Slots available for DLBCL: 1 of 1 Slot
Key Information:
Study drug: TAK-007 (cryopreserved cord blood NK CAR).
TAK-007 is a cryopreserved cord blood NK CAR
Accepts R/R large B-cell lymphoma subtypes, FL gr 1-3b, and MZL after 2 lines of systemic therapy
PI: Strati, Paolo Contact: Laurel Deaton Phone: fldeaton@mdanderson.org
Protocol Eligibility Requirements for 2021-0583 Major Inclusion Criteria: 1. R/R refractory CD19 expressing disease after at least 2 lines of therapy: a. LBCL, including subtypes defined by the WHO and FL gr 3b. (must have prior anti-CD20 mAb and an anthracycline containing chemotherapy regimen and failed or be ineligible for high-dose chemotherapy and ASCT) b. FL and MZL (must have prior anti-CD20 mAb and an alkylating agent) 2. ECOG 0 or 1 3. ANC >500; plts >50; eGFR ≥30 mL/min 4. LVEF ≥40% 5. No evidence of clinically relevant pericardial effusion, and no acute clinically significant ECG findings. 6. Absence of Grade ≥2 pleural effusion. Baseline O2 sat >92% on RA
Major Exclusion Criteria: 1. CNS lymphoma, BL, MCL, LPL, or Richter's 2. Hx of anti-CD19 therapy 3. Hx of malignancy other than nonmelanoma skin cancer, carcinoma in situ, low-grade tumors deemed to be cured and not treated with systemic therapy unless disease free for ≥3 years 4. Auto or allo SCT within 3 months 5. Active infection. 6. Active HIV, HBV, HCV, or Covid-19 infection at screening 7. Clinically relevant CNS disorder 8. Clinically significant cardiac condition within 12 months 9. DVT or PE within 6 months 10. Hx of autoimmune disease or solid organ transplantation, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years.
Protocol Summary for 2021-0583
A Phase 1, Multicenter, Open-Label Study of CB-010, a CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy in Patients with Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
Protocol Number: 2020-1041 Slots available for DLBCL: 15 OUT OF 15 Key Information:
Phase 1 study of CB-010, a CRISPR-edited allogeneic anti-CD19 CAR-T cell therapy in R/R B-cell NHL (DLBCL, tFL, PMBCL, HGBCL, MCL, FL, and MZL) PI: Nastoupil, Loretta Contact: Dsouza, Ly Phone: 832-817-8154
Protocol Eligibility Requirements for 2020-1041
Inclusion: DLBCL, HGBL, tFL, PMBCL Prior therapy must include anti-CD20 Ab and anthracycline and 1 or more of the following: Primary refractory diseaseNo response to second or more lines of therapy Refractory post ASCT FL or MZL Failed an anti-CD20 Ab and alkylating agent Best response to most recent therapy was PD MCL Failed anti-CD20 Ab, alkylating agent, and BTKi ECOG of 0 or 1 Oxygen saturation > 92% on room air with ≤ Grade 1 dyspnea Cardiac ejection fraction > 50% and no evidence of pericardial effusion or clinically significant ECG findings Laboratory parameters as follows: Serum albumin ≥ 3.0 g/dL; ALT/AST ≤ 2.5 × ULN; ANC ≥ 1000/uL; Platelet count ≥ 75,000/uL; Serum creatinine ≤ 1.5 × ULN, or calculated creatine clearance > 60 mL/min by Cockcroft Gault formula or estimated glomerular filtration rate > 60 mL/min/1.73 m2; Total bilirubin ≤ 1.5 mg/dL
Exclusion: History of prior therapy with an anti-CD19 targeting agent Active acute or chronic GvHD requiring therapy History of allogeneic stem cell transplantation ASCT within 8 weeks of informed consent Clinically significant CNS dysfunction or disease. Current thyroid disorder (including hyperthyroidism). Hypothyroidism controlled with a stable dose of hormone replacement therapy is permitted History of HIV. Active hepatitis B or C virus infection. Requirement for urgent therapy because of tumor mass effects such as bowel obstruction or blood vessel compression Presence of pleural, peritoneal or pericardial catheter Clinically significant pleural effusion History of significant cardiac disease within 12 months of enrollment Concurrent or previous other malignancy within 2 years of study entry, except curatively treated malignancies. History of autoimmune disease resulting in end organ injury or requiring within the last 2 years systemic immunosuppressive or disease modifying agents
Protocol Summary for 2020-1041
An Open-Label, Phase 2 Trial of Nanatinostat in Combination with Valganciclovir in Patients with Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas (NAVAL-1)
Protocol Number: 2021-0463 Slots available for DLBCL: 10 slots open Key Information:
1.EBV+ diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) 2. Extranodal NK/T-cell lymphoma (ENKTL) 3. Peripheral T-cell lymphoma (PTCL), including PTCL-NOS and angioimmunoblastic T-cell lymphoma (AITL): • 3a: Nanatinostat monotherapy • 3b: Nanatinostat + valganciclovir 4. Hodgkin lymphoma (HL) 5. Post-transplant lymphoproliferative disorder (PTLD) 6. Lymphomas associated with human immunodeficiency virus (HIV) infection (HIV-L): Plasmablastic, Burkitt, Hodgkin and DLBCL 7. EBV+ lymphomas other than the above PI: Nair, Ranjit Contact: Jenna Wixom Phone: (713) 416-3951
Protocol Key Eligibility Requirements for: 2021-0463
Protocol Abstract for 2021-0463
A multicenter phase 2 study of belantamab mafodotin in relapsed or refractory plasmablastic lymphoma and ALK+ large B-cell lymphoma
Protocol Number: 2021-0181 Slots available for DLBCL: 4 slots open Key Information:
Participants must have relapsed or refractory plasmablastic lymphoma or ALK+ large B-cell lymphoma by WHO criteria Participants must have received prior systemic lymphoma therapy Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter [LDi] to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥15 mm in LDi for nodal disease or >10 mm in LDi for extranodal lesions Must have:
absolute neutrophil count ≥1,000/mcL platelets ≥50,000/mcL hemoglobin ≥ 8.0 g/dL
PI: Nair, Ranjit Contact: Thomas, Merlin Phone: 346-464-4569
A Phase 1 Safety and Efficacy Study of ADI-001 Anti-CD20 CAR-engineered Allogeneic Gamma Delta (γδ) T Cells in Adults with B Cell Malignancies, in Monotherapy and Combination with IL-2
Protocol Number: 2020-1137 Slots available for DLBCL:
1
Key Information:
2 prior lines of systemic therapy, including an anthracycline or alkylator and at least 1 BTK inhibitor and anti-CD20 monoclonal antibody. PI:
Neelapu, Sattva
Contact:
Johncy, Swapna
Phone:
(713) 792-8251
Protocol Key Eligibility Requirements for: 2020-1137 Inclusion Patients with R/R B cell malignancies including DLBCL,HGBCL,MCL,FL,MZL, PMBCL, Burkitts Lymphoma. Prior therapies:MCL - 2 prior lines of systemic therapy, including an anthracycline or alkylator and at least 1 BTK inhibitor and anti-CD20 monoclonal antibody. Large B cell lymphomas including DLBCL, HGBCL, tFL, and PMBCL- 2 prior lines of therapy, including an anthracycline and anti-CD20 monoclonal antibody therapy. FL and MZL- 2 prior lines of systemic therapy, including an alkylator and an anti-CD20 monoclonal antibody therapy. Monotherapy with anti CD20 monoclonal antibody will not be considered as a line of therapy. Exclusion CNS Involvement ASCT within 45 days of screening
Known CD20 negative tumor Active uncontrolled fungal, bacterial, viral, protozoal, or other infection.
Any form of primary immunodeficiency (e.g., severe combined immunodeficiency disease). History of human immunodeficiency virus (HIV) infection. Active hepatitis B or hepatitis C.
Protocol Summary for 2020-1137
A Phase I/II Open Label, Single Center, Study of the Combination of ALX148, Rituximab and Lenalidomide in Patients with Indolent and Aggressive B-cell Non-Hodgkin Lymphoma
Protocol Number: 2021-0226 Slots available for DLBCL: 0 OUT OF 28 Key Information: phase 1 3+3 design max 28 patients; phase II 24 patients Phase I: have failed at least 1 line of therapy; MCL & aggressive b-cell lymphoma 2 prior lines, ANC 1, PLT 75, Hgb 8
PI: Strati, Paolo Contact: Davidson, Jeffry Phone: (713) 745-5095 Pager:
Protocol Key Eligibility Requirements for: 2021-0226
Protocol Fact Sheet for: 2021-0226
A Phase 1b, open label, global, multicenter, dose determination, randomized dose expansion study to determine the maximum tolerated dose, assess the safety and tolerability, pharmacokinetics and preliminary efficacy of iberdomide (CC-220) in combination with R- CHOP-21 and CC-99282 in combination with R-CHOP-21 for subjects with previously untreated, poor risk (IPI 3 to 5), aggressive B-cell lymphoma
Protocol Number: 2021-0369 Slots available for DLBCL: 10 of 10 Slots available
Key Information:
Frequent Mandatory Core & FNA biopsies Frequent CTRC Research Labs IPI 2-5 Measurable disease >1.5cm Hgb>8 & Plt >75K without transfusions or growth factors.. PI: Westin, Jason Contact: Awolowo, Kemi
Phone: 713-745-1414
A randomized trial of fecal microbiota transplantation for remedying antibiotics-induced microbiota dysbiosis in lymphoma patients receiving Axicabtagene Ciloleucel therapy
Protocol Number: 2023-0581 Slots available for DLBCL: 10 Slots available
Key Information:
Fecal Microbiota Transplant Patients planned to undergo standard of care Axicatagene Ciloelucel Therapy Exposed to broad-spectrum antibiotics within last 180 days PI: Saini, Neeraj
Contact: Dent, Kylie
Phone: 713-563-5847
Eligibility Requirements for 2021-0369
Inclusion:
Exclusion:
Protocol Fact Sheet for 2021-0369
A Phase 1, First-in-Human, Dose Escalation Study of the JNJ-75348780 Bispecific Antibody Targeting CD3 and CD22 in Participants with NHL and CLL
Protocol Number: 2021-0203 Slots available for DLBCL: 0 OUT OF 3 Key Information:Patients with R/R B-cell NHL DLBCL: received or not eligible for high-dose chemotherapy and autologous stem cell transplantation with curative intent. ECOG 0-1 Adequate lab parameters without transfusion or growth factors for at least 7 days prior to first dose of study drug No known active CNS involvement No active autoimmune disease No significant cardiovascular disease
PI: Chihara, Dai Contact: Nunmaker, Amanda Phone: 3467252997 Email: amnunmaker@mdanderson.org
Phase 2 Trial of Epcoritamab in combination with Rituximab-mini CVP for Older Unfit/Frail Patients or Anthracycline-Ineligible Adult Patients with Newly Diagnosed Diffuse Large B-cell Lymphoma
Protocol Number: 2023-0031 Slots available for DLBCL: 40 OUT OF 40 Key Information:
Inclusions: - Ineligible for anthracycline-based chemotherapy due to: Age ≥80, Unfit/frail by simplified geriatric scale, EF <50% but ≥30%, or previous cardiotoxic cancer treatment with anthracycline - Stage II bulky, III, or IV disease - Performance status ≤2 on the ECOG scale (PS ≤3 if attributed to lymphoma and improves to ≤2 by pre-phase treatment prior to enrollment) - Measurable disease - Adequate organ and marrow function - Creatinine clearance >45ml/min
Exclusions: - Known CNS lymphoma or leptomeningeal disease - Uncontrolled HIV, Hepatitis B, or Hepatitis C - History of immunodeficiency or concurrent systemic immunosuppressant therapy - Clinically significant cardiovascular disease - QTcF >470 msec - Patients with pericardial effusion - Prior exposure to Epcoritamab - Neuropathy > grade 1
PI: Chihara, Dai Contact: Nunmaker, Amanda Phone: 3467252997 Email: amnunmaker@mdanderson.org
An open-label phase II study to investigate the efficacy, safety, and pharmacokinetics of tirabrutinib in patients with Primary Central Nervous System Lymphoma (PCNSL)
Protocol Number: 2023-0329 Slots available for DLBCL: Part A: Relapsed/Refractory= CNPE; Part B: Newly diagnosed, R-MPV regimen- 0 slots available, MTR regimen- 20 slots
Part A: Relapsed/Refractory PCNSL slots available; Part B: Newly diagnosed, R-MPV regimen- 0 slots available, MTR regimen- 0 slots Key Information: Primary Central Nervous System Lymphoma Newly diagnosed or Relapsed/Refractory
Key Inclusion Criteria: - Measurable brain lesion with a minimum diameter >1.0cm in gadolinium enhanced MRI - ECOG of 0, 1, or 2 - Adequate bone marrow, renal, and hepatic function - Part A: Relapse or refractory PCNSL with at least 1 prior HD-MTX based therapy - Part B: No prior anti-tumor treatments for PCNSL, and are suitable to receive treatment with a HD-MTX containing regimen
Key Exclusion Criteria: - Intraocular PCNSL with no brain lesion - Patients with systemic presence of lymphoma - Prior allogenic stem cell transplant within 6 months - Concomitant systemic corticosteroid on an ongoing basis within 14 days before starting treatment - Concomitant Warfarin, Vitamin K antagonists, or antiplatelet therapy on an ongoing basis - Poorly controlled comorbidity (severe heart disease, lung disease, liver disease, hepatic impairment) - Active infection - QTcF >480 or requirement for ongoing treatment with concomitant medications that prolong the QT interval - Patient with bleeding diathesis
PI: Chihara, Dai Contact: Nunmaker, Amanda Phone: 3467252997 Email: amnunmaker@mdanderson.org
A Phase 1/1b, Open-label Multi-center Two-part Study of SETD2 Inhibitor EZM0414 in Subjects with Relapsed/refractory Multiple Myeloma and Relapsed/refractory Diffuse Large B Cell Lymphoma
Protocol Number: 2021-0915 Slots available for DLBCL: Approval by sponsor Key Information:
- sufficient organ and marrow function - No history of CNS lymphoma - No Cardiac impairment - R/R with at least 2 prior lines - must have measurable disease
PI: Chihara, Dai Contact: Ogunlere Anuoluwa Phone: Email: AOOgunlere@mdanderson.org
Protocol Summary for 2021-0915
A Multicenter, Open-label Feasibility Study of Daratumumab with Dose-Adjusted EPOCH in Newly Diagnosed Plasmablastic Lymphoma with or without HIV
Protocol Number: 2021-1088 Slots available for DLBCL: 5 slots available
Key Information:
Daratumumab + EPOCH for patients diagnosed with plasmablastic lymphoma. Patients that have already had one cycle of EPOCH are still eligible if we can start them on Dara+EPOCH within 21-28 days of their first cycle. HIV+ allowed.
PI: Chihara, Dai Contact: Wixom, Jenna Phone: 713-416-3951 Email: JMWixom@mdanderson.org
Protocol Eligibility Requirements for 2021-1088 Inclusion:
Exclusion:
A Phase 1/2 Open-label, Multicenter Study Evaluating the Safety and Efficacy of KITE-363, an Autologous Anti-CD19/CD20 CAR T-cell Therapy, in Subjects With Relapsed and/or Refractory B-cell Lymphoma
Protocol Number: 2020-1136 Slots available for DLBCL: 1 OUT OF 10
Key Information:
Currently in dose escalation phase, slots are staggered . PI: Loretta Nastoupil Contact: Ly, Dsouza Phone: (832)-817-8154
Protocol Eligibility Requirements for 2020-1136 Inclusion:
Exclusion:
Protocol Summary for 2020-1136
A Phase 1, First-in-Human, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-67856633, an Inhibitor of MALT1, in Participants With NHL and CLL
Protocol Number: 2020-0452 Slots available for DLBCL: 15 OUT OF 15 CNPE
Protocol is terminated.
Key Information:
ECOG of 0-1 Labs: Hgb ≥8 g/dL, Plt ≥75×109/L, ANC ≥1.0×109/L, AST, ALT, GGT, and alkaline phosphatase ≤2.5× ULN, Serum total bilirubin ≤1.5× ULN, calculated or measured creatinine clearance ≥40 mL/min. Exclusion: Known active CNS involvement, prior solid organ transplant, active autoimmune disease requiring systemic immunosuppressive meds and active or chronic Hep B, C, HIV infection. PI: Samaniego, Felipe Contact: jennramos@mdanderson.org Phone: 713-563-5426
Protocol Eligibility Requirements for 2020-0452 Inclusion: ECOG of 0-1 Hgb ≥8 g/dL, Plt ≥75×109/L, ANC ≥1.0×109/L, AST, ALT, GGT, and alkaline phosphatase ≤2.5× ULN, Serum total bilirubin ≤1.5× ULN, calculated or measured creatinine clearance ≥40 mL/min. Exclusion: Known active CNS involvement prior solid organ transplant active autoimmune disease requiring systemic immunosuppressive meds active or chronic Hep B, C, HIV infection
Protocol Summary for 2020-0452
A Phase II Study to Determine the Response Kinetics, Safety and Efficacy of Brentuximab Vedotin and Nivolumab Alone and Combined with Rituximab, Cyclophosphamide, Doxorubicin and Prednisone for Patients with Untreated Primary Mediastinal Large B-cell Lymphoma
Protocol Number: 2020-0686 Slots available for DLBCL: Key Information:
PI: Nair, Ranjit Contact: Lal, Ana Phone: 713-745-5078
Protocol Eligibility Requirements for 2020-0686
Inclusion:
> 1% of CD30 expression of PMBL No prior treatment except prior limited-field radiotherapy, a short course (up to 7 days) of glucocorticoids ≤100mg daily, and/or cyclophosphamide (wash-out of a 10 days required) Stage of Patients: Stages II, III, IV, and stage I ≥ 5 cm in the greatest dimension ANC >1000/mm3 and platelets >100,000/mm3 unless deemed related to lymphoma involvement in the bone marrow
Protocol Summary for 2020-0686
Protocol Abstract for 2020-0686 CC-99282 (next gen cereblon inhibitor)+/- Rituximab for R/R NHL
Protocol Number: 2018-1160 Slots available for DLBCL: 20
Key Information:
multiple arms available. 0.2mg and 0.4mg 14/28 days (14 days on 14 days off) protocol is currently enrolling R/R DLBCL and R/R FL only. PART B Dose expansion 2 prior lines or DLBCL 1 prior line AND not eligible for SCT ANC > 1.5, plt >75, CrCl > 60 ECOG 0-2 no symptomatic CNS involvement PI: Nastoupil, Loretta Contact: Averill, Barbara Phone: (713) 745-9910 Pager: (713) 404-7577
Protocol Eligibility Requirements for 2018-1160
Inclusion:
DLBCL, FL, MCL, PCNSL with relapsed/refractory disease with at least 2 prior lines of therapy. Measurable disease ECOG 0-2 ANC > 1.5 x 109/L without growth factor support for 7 days (14 days if pegfilgastrim), Hgb > 8 g/dL, plt > 75 x 109/L without transfusion for 7 days, Estimated serum creatinine clearance of > 50 mL/min Exclusion Criteria
Life expectancy > 2 months prior CAR-T or other T-cell targeting treatment < 4 weeks prior to starting CC-99282 prior therapy with CRBN-modulating drug (eg, lenalidomide, avadomide/CC-122, pomalidomide) < 4 weeks prior to starting CC-99282 symptomatic CNS involvement of disease (does not apply to PCNSL subjects) Peripheral neuropathy NCI CTCAE Grade 2 Subject had prior autologous SCT < 3 months prior to starting CC-99282 and any treatment-related toxicity is unresolved (grade > 1) Subject had prior allogeneic SCT with either standard or reduced intensity conditioning ? 6 months prior to starting CC-99282 and any treatment-related toxicity is unresolved (grade > 1) Prior radiotherapy within one month prior to starting study drug
Protocol Summary for 2018-1160
Protocol Abstract for 2018-1160
View more available DLBCL (not CAR-T) protocols?
Yes
CG-806 (Pan-FLT3/BTK Multi-Kinase Inhibitor) for R/R CLL/SLL & NHL
Protocol Number: 2019-0313 Slots available for DLBCL: 15 OUT OF 18; 5/5/22 Open for enrollment
Study is on temporary enrollment hold to complete data collection for G3 substudy as all slots have been filled.
No longer requires 2 or more prior lines of therapy, allows for one or more lines of therapy for all subtypes of NHL and CLL. G3 study has 2 slots available for the 200mg slot and cohort 6 is filled but may consider additional patients .
Key Information:
No longer requires 2 or more prior therapies. Only requires one or more prior therapies. ECOG < /= 2 NHL pt must have measurable disease of 1.5cm or greater CLL must have clonal population of lymphocytes in their blood and lymphocytosis > 5 x 10^9cells/L or hepatomegaly or splenomegaly consistent with disease infiltration Prior use of iburutinib allowed enrollment currently on hold and waiting on amendment 7 approval for new formulation. PI: Samaniego, Felipe Contact: Ramos, Jennifer Phone: (713) 563-5426
Protocol Key Eligibility Requirements for 2019-0313
Inclusion: Pathologically documented relapsed or refractory B cell NHL or CLL/SLL who have failed or are intolerant to 2 or more lines of established therapy, or for whom no other treatment options are available in the opinion of the investigator. - Resistance is defined as having failed to achieve a CR or PR with the most recent line of therapy Patients with FL, MZL and WM must require systemic therapy. All patients must have measurable disease. For NHL patients, tumor masses these must be bidimensionally measurable by physical examination, (CT, MRI or PET-CT. When measurable disease consists of peripheral lymph nodes, the target lymph nodes must be >/=1.5 cm in longest diameter. Patients with CLL must have a clonal population of lymphocytes in their blood and a lymphocytotosis of> 5 x 1 0J\9 cells/L. Patients with WM must have a monoclonal immunoglobin identifiable with SPEP whose concentration is elevated above normal limits. Prior use of ibrutinib or other covalent or non-covalent BTK inhibitor is allowed; the patient is eligible even after failing ibrutinib or other covalent or non-covalent BTK inhibitor due to lack of response or adverse events including atrial fibrillation. Patients who have had prior Auto or Allo SCT are eligible as long as they are >90 days post-transplant and do not require systemic immunosuppressive treatment for GVHD. Patients may have received prior radiation but must be >21 days since the last dose of external beam radiation therapy. Life expectancy of at least 2 months ECOG < /= 2 Cardiovascular parameters that must be met within 28 days of study treatment: - QTcF < /=450 msec for males, QTcF < /=470 msec for females Hematologic parameters that must be met within 28 days of study treatment: - ANC>/= 1,000 cells/µL - Platelet count>/= 50,000 cells/µL - If neutropenia or thrombocytopenia is believed to be due to marrow infiltration with malignant cells then there are no lower limits for the absolute neutrophil or platelet count for initiation or re-initiation of study drug retreatment. - INR/PT and aPTT < /=1.5 times ULN Renal & Liver function parameters that must be met within 28 days of study treatment: -All patients must have a CrCl >/= 60 ml/min, Adequate liver function tests (LFT): Total and direct bilirubin < /= 1.5 x the institutional ULN; AL T/AST < /= 2.5 x ULN Exclusion Criteria: Receipt of cytotoxic therapy within the preceding 14 days, or within 5 half-lives for prior noncytotoxic agents, prior to first study treatment administration Unresolved clinically significant toxicities of Grade 2 or higher from prior therapies Treatment with other investigational drugs within 14 days prior to first study treatment administration Patients with GVHD requiring systemic immunosuppressive therapy Patients with a known bleeding diathesis including anti-coagulation with any form of anticoagulant, coagulation factor deficiency, coagulopathy, prior major bleeding episode unrelated to surgery or trauma or stroke. Patients with another active malignancy requiring systemic therapy Leptomeningeal or CNS disease Uncontrolled auto-immune hemolytic anemia Major surgery < /= 14 days prior to signature of ICF and no minor surgery < /= 3 days prior to signature of ICF (with the exception of intravenous (IV) access placement, e.g. Hickman or PICC). Uncontrolled serious illness or medical conditions, which in the Investigator's opinion could hamper understanding of the study by the patient, patient's compliance to study treatment, patient's safety, or interpretation of study results. Need to concurrently take drugs that are substrates or known moderate or strong inhibitors of CYP2C8, CYP2C9, and CYP3A4/5 and drugs associated with a high risk of QT prolongation and torsades de pointes
Protocol Summary for 2019-0313
Protocol Abstract for 2019-0313
VLS-101 (antibody drug conjugate) for Hem Malignancies Protocol Number: 2018-0996 Slots available for DLBCL:
5 OUT OF 15 Key Information:
PI:
Wang, Michael
Contact:
Fischer, Kim
Phone:
(713) 563-4319
Pager:
(713) 606-4456
Protocol Key Eligibility Requirements for 2018-0996
Inclusion:
Age 18 or older ECOG 0-2 Histological diagnosis of MCL, FL, MZL, DLBCL, or RTL Presence of measurable lymphadenopathy or extranodal malignancy Adequate bone marrow function without hematopoietic support Adequate hepatic profile Adequate Renal Function Adequate coagulation profile
Exclusion Criteria Malignancy involving the central nervous system Significant cardiovascular disease Significant screening ECG abnormalities Candidacy for hematopoietic stem cell transplantation or CAR T cell therapy, with access to HSCT or CAR T cells and a willingness to undergo such therapy Prior therapy with a TOT1-directed therapy or with a MMAE-containing drug Use of string inhibitor or inducer of CYP3A4 within 7 days prior to start of study therapy Use of a drug known to prolong the QT interval within 7 days prior to the start of study
Protocol Summary for 2018-0996
Protocol Abstract for 2018-0996
Phase 1 Open-label, Multicenter Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of IGM-2323 in R/R NHL
Protocol Number: 2019-0644 Slots available for DLBCL: 30 OUT OF 30 CNPE
Key Information:
DOSE ESCALATION must be CD20+ 2 prior lines FL, DLBCL, or other histology ECOG 0-1 excludes double, triple hit and Richter's transformation PI: Nastoupil, Loretta Contact: Averill, Barbara Phone: (713) 745-9910 Pager: (713) 404-7577
Protocol Key Eligibility Requirements for: 2019-0644 Inclusion Histologically confirmed FL Grades 1-3a, or Grade 3b. Or Histologically confirmed DLBCL or trFL. Or Additional CD20-positive NHL R/R to at least 2 prior systemic treatment regimens Not eligible for aHSCT, due to chemoresistant disease, medically unfit for transplant, or unwilling to proceed, and there is no readily available standard therapy expected to improve survival. Medical fitness criteria include cardiac ejection fraction > 50%, Creatinine < LLN, Pulmonary function tests of FEV1/DLCO > 70% predicted, and successful mobilization of CD34+ cells. Eligibility will be assessed by the treating physician and rationale for assessment will be recorded. Unwillingness to proceed per the patient will be documented through the informed consent process, after aHSCT risks and benefits are clearly described to the patient and the subject has been made aware of all therapeutic options. At least 1 bi-dimensionally measurable lesion (> / = 1.5 cm) in longest dimension by CT scan. ECOG Status of 0 or 1. LABS: ANC > / = 1000/mm3; Total hemoglobin > / = 9 g/dL without transfusion within 21 days prior to first dose of IGM-2323; Platelet count > / = 75,000/mm2 without transfusion within 14 days prior to the first dose of IGM-2323; Serum Cr < ULN, or estimated CrCL > / = 50 mL/min; ALT/AST < / = 3 x ULN; Total bilirubin < / = 1.5 mg/dL, (except in subj with Gilbert's Syndrome < / = 1.5 mg/dL of direct bilirubin). Cardiac ejection fraction > / = 50%, by ECHO or MUGA. Baseline oxygen saturation > 92% on room air. No clinically significant pleural effusion. Subjects treated with alemtuzumab, fludarabine, cladribine, or pentostatin within 6 months before the first dose of IGM-2323 may be enrolled only with Medical Monitor approval.
Exclusion Known Double/Triple Hit Lymphoma (MYC, and BCL-2 or BCL-6 translocation). CLL, or Richters transformation. Known lack of cancer cell CD20 expression as measured by IHC, flow cytometry, gene expression, or another assay. Current eligibility for ASCT in subjects with R/R DLBCL or R/R trFL. Impending obstruction due to lymphoma, such as superior vena cava syndrome, or any other sensitive site at risk for expanding mass effect. Absolute B-cell lymphocyte count > 5,000/mm3 Prior AlloSCT, solid organ transplant, ASCT within 100 days prior to first IGM 2323 administration Lack of response to prior treatment with CAR-T therapy, subjects with less than 6 months from prior CAR-T therapy to first dose of IGM-2323, and prior CAR-T therapy only allowed with Medical Monitor approval. Prior use of any mAb protein therapeutic, within 3 weeks prior to the first dose of IGM-2323. Prior use of any radioimmunoconjugate or antibody drug conjugate within 4 weeks prior to the first dose of IGM-2323. Prior treatment with systemic immunotherapeutic agents, including but not limited to cytokine therapy and anti-CTLA4, anti-PD-1, anti-PD-L1 therapeutic antibodies within 4 weeks prior to first dose of IGM-2323. Treatment with any chemotherapeutic agent or treatment with any other anti-cancer agent within 3 weeks prior to first IGM-2323 administration. Treatment with radiotherapy within 1 week prior to the first IGM-2323 administration. If subjects have received radiotherapy within 4 weeks prior to the first IGM-2323 administration, subjects must have at least 1 measurable lesion outside of the radiation field. Subjects who have only 1 measurable lesion that was previously irradiated but subsequently progressed are eligible. CNS lymphoma Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease. Subjects with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurologic deficits as judged by the Investigator are allowed. Subjects with a history of epilepsy who have had no seizures in the past 2 years while not receiving any anti-epileptic medications are allowed in the expansion cohorts only. Known active bacterial, viral, fungal, mycobacterial, parasitic or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to the first IGM-2323 administration. Subjects with a history of confirmed progressive multifocal leukoencephalopathy. Known or suspected chronic active Epstein Barr Virus infection Positive serologic or PCR test results for acute or chronic HBV infection. Acute or chronic HCV infection. Subjects who are positive for HCV antibody must be negative for HCV by PCR to be eligible for study participation. Known history of HIV seropositivity. Active autoimmune disease. Received systemic immunosuppressive medications with the exception of corticosteroid treatment < / = 10 mg/day prednisone or equivalent within 2 weeks prior to first dose of IGM-2323. Subj who received acute, low-dose, systemic immunosuppressant meds may be enrolled after discussion w/ and w/ approval of Med Monitor. Use of topical, intranasal, or inhaled corticosteroids permitted. Use of mineralocorticoids for management of orthostatic hypotension permitted. Use of physiologic dose of corticosteroids for management of adrenal insufficiency permitted. Use of corticosteroids to prevent CT contrast dye reaction Presence of an abnormal ECG or history of rhythm disorder that is clinically significant in the Investigator's opinion, including uncontrolled atrial fibrillation/flutter or any unstable arrhythmias, second or third-degree AV Unstable angina, myocardial infarction, cardiac angioplasty or stenting within the last 6 months. Significant congestive heart failure, such as New York Heart Association Class III or IV. Significant active pulmonary disease History of symptomatic DVT or pulmonary embolism within 6 months of enrollment. History of upper extremity line related DVT within 3 months.
Protocol Abstract for 2019-0644
Protocol Fact Sheet for 2019-0644
A SINGLE-ARM, OPEN-LABEL, PHASE 1/2 STUDY EVALUATING THE SAFETY, EFFICACY, AND CELLULAR KINETICS/PHARMACODYNAMICS OF ALLO--501A, AN ANTI-CD19 ALLOGENEIC CAR T CELL THERAPY IN SUBJECTS WITH RELAPSED/REFRACTORY LARGE B-CELL LYMPHOMA (LBCL)
Protocol Number: 2020-0184 Slots available for CLL: 1 Key Information:
Need to fail 2 lines of treatment PI: Neelapu, Sattva Contact: Binoy, Swapna Phone: (832) 454-5666
A SINGLE-ARM, OPEN-LABEL, PHASE 1/2 STUDY EVALUATING THE SAFETY, EFFICACY, AND CELLULAR KINETICS/PHARMACODYNAMICS OF ALLO--501A, AN ANTI-CD19 ALLOGENEIC CAR T CELL THERAPY IN SUBJECTS WITH RELAPSED/REFRACTORY LARGE B-CELL LYMPHOMA (LBCL)
Protocol Number: 2020-0184 Slots available for DLBCL:
1
Key Information:
Prefer post SOC relapse & FL 3B PI:
Neelapu, Sattva
Contact:
Johncy, Swapna
Phone:
(832) 454-5666
Protocol Key Eligibility Requirements for: 2020-0184
Inclusion: It is allogeneic CD19 CAR T. DLBCL, PMBCL, transformed FL, high-grade BCL, FL 3B Must have received at least 2 lines of prior therapies. ANC >/= 1000 and Platelet count >50k Will take post anti CD 19 CAR T Therapy if relapse is CD19+ Exclusion: CNS & Cardiac lymphoma ASCT within 6 weeks or ALLO SCT within 3 months of screening Active uncontrolled fungal, bacterial, viral, protozoal, or other infection. Any form of primary immunodeficiency (e.g., severe combined immunodeficiency disease). History of human immunodeficiency virus (HIV) infection. Active hepatitis B or hepatitis C.
Protocol Fact Sheet for 2020-0184
Protocol Abstract for 2020-0184
View more available DLBCL (3+L CAR-T) protocols?
Yes
A Multicenter, Phase 1, Open-label, Dose-escalation and Expansion Study of TNB-486, a Bispecific Antibody Targeting CD19 in Subjects with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
Protocol Number: 2021-0091 Slots available for DLBCL: 0 OUT OF 2
Key Information:
Subject has biopsy proven B-NHL Subject has biopsy proven RR DLBCL or HGBL Subject has biopsy proven RR FL (Grade 1-3a) Subject has biopsy proven RR FL Subject has greater than 1 measurable disease site(s) as defined in the RECIL 2017 classification Lymphoma (B-NHL) who have received 2 or more prior lines of therapy and who are not appropriate candidates for treatment regimens known to provide clinical benefit in B-NHL will be enrolled. • diffuse large B-cell Lymphoma • primary mediastinal B-cell lymphoma), high-grade B-cell lymphoma ( • transformed indolent NHL including Richter's transformation • mantle cell lymphoma (MCL) • follicular lymphoma (FL, Grade 1-3) marginal zone lymphoma (MZL) PI: Nair, Ranjit Contact: Ana Lal Phone: (713) 745-5078
Protocol Eligibility Requirements for 2021-0091
Inclusion: Received 2 or more prior lines of therapy DLBCL including subtypesprimary mediastinal B-cell lymphoma high-grade B-cell lymphoma (HGBL; including subtypes such as HGBL with MYC and BCL2 and/or BCL6 rearrangements) transformed indolent NHL including Richter's transformation mantle cell lymphoma (MCL) follicular lymphoma (FL, Grade 1-3), marginal zone lymphoma (MZL) B-NHL disease is CD19-positive. CD19 positivity is defined as expression of CD19 on ≥ 50% of tumor cells ECOG 0,1,2 Laboratory parameters as follows: (ANC) ≥ 1000/mm3; platelets ≥ 50,000/mm3; hemoglobin ≥ 8.0 g/dL; estimated glomerular filtration rate (eGFR) ≥ 50 mL/min as estimated by the MDRD formula Exclusion: Diagnosed with or treated for another malignancy, requiring treatment. History of CNS involvement by their B-NHL. Subject has a history of leukemic presentation of their B-NHL, except for MCL or MZL. Active infection Peripheral autologous SCT within 12 weeks, or an allogeneic SCT within 1 year. Major cardiac abnormalities. On chronic immunosuppressive therapy (eg > 10 mg prednisone/day).
Protocol Summary for 2021-0091
A Phase I Study of FT516 as Monotherapy in R/R AML and in Combination with Monoclonal Antibodies in R/R B-Cell Lymphoma
Protocol Number: 2019-0615 Slots available for DLBCL: 1 OUT OF 1 Key Information:
NK Cell protocol. Eligible patients include patients who relapse after CAR T (including CD19 negative relapse). those that can't wait 2-3 for manufacturing of autologous CAR T patients with co-morbid health conditions LVEF >40%, CrCl >50 ml/min required. PI: Strati, Paolo Contact: Laurel Deaton
Email: fldeaton@mdanderson.org
Protocol Key Eligibility Requirements for: 2019-0615 Inclusion
Regimen A (FT516 monotherapy):
Primary Refractory AML De Novo AML: no CR after 2 or more induction attempts; if >60 years of age, only 1 induction attempt is required. 7+3 followed by 5+2 counts as 2 induction attempts Secondary AML (from MDS or treatment related): no CR after 1 or more induction attempt Relapsed AML defined as not in CR after 1 or more re-induction attempts; if >60 years of age, prior re-induction therapy is not required. Subjects with relapse following allogeneic HSCT will not be required to undergo re-induction therapy For hypomethylating agents, e.g., decitabine or azacitidine as single agent or in combination to count as an induction/re-induction attempt, the subject must have completed a minimum of 2 months of treatment without attaining CR For targeting agents, e.g., sorafenib or venetoclax as single agent or in combination to count as an induction/re-induction attempt, the subject must have completed a minimum of 2 months of treatment without attaining CR Regimen B (FT516 + rituximab or obinutuzumab):
Histologically documented B-cell lymphoma expected to express CD20 Relapsed/refractory disease following at least 1 prior systemic immunochemotherapy regimen, and for whom there is no available therapy expected to improve survival At least 1 bi-dimensionally measurable lesion (>1.5 cm in longest dimension by CT scan) For subjects with >1 measurable lesion, agreement to undergo a biopsy from a safely accessible site per Investigator assessment for exploratory biomarker assessments Presence of measurable disease Exclusion Females who are pregnant or breastfeeding ECOG Status >/=2 Evidence of insufficient organ function as determined by any one of the following: AML: no count restrictions for neutrophils or platelets Lymphoma: neutrophils < 1000/µL; or platelets < 75,000/µL Estimated creatinine clearance < 50 mL/minute by Cockcroft-Gault method or other standard institutional method Total bilirubin >1.5 xULN, not applicable for subjects with Gilbert's syndrome AST >3 x ULN, or ALT >3 x ULN, not applicable if determined to be directly due to underlying malignancy Receipt of any biological therapy, chemotherapy, or radiation (except palliative radiation, rituximab or obinutuzumab) within 2 weeks prior to Cycle 1 Day 1 or five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to Cycle 1 Day 1. For subjects with r/r AML, maintenance hydroxyurea for blast control up to the initiation of lympho-conditioning is permitted. Currently receiving or likely to require systemic immunosuppressive therapy (e.g., prednisone >5 mg daily) for any reason from Day -5 to Day 29, with the exception of corticosteroids as a premedication required for obinutuzumab in Regimen B Prior allogeneic HSCT or allogeneic CAR-T within 6 months of Cycle 1 Day 1, or ongoing requirement for systemic graft-versus-host therapy Receipt of an allograft organ transplant CNS involvement by malignancy. Subjects with prior CNS involvement with their malignancy must have completed effective treatment of their CNS disease at least 3 months prior to Day 1 with no evidence of disease clinically and at least stable findings on relevant CNS imaging. AML subjects with known prior history of CNS involvement should have a LP as part of eligibility screening. Clinically significant cardiovascular disease including any of the following: stroke or myocardial infarction within 6 months prior to first study medication; unstable angina or congestive heart failure of New York Heart Association Grade 2 or higher; cardiac ejection fraction < 40% Clinically significant infections including: HIV, HBV, HCV Live vaccine < 6 weeks prior to start of lympho-conditioning Known allergy to the following FT516 components: albumin (human) or DMSO Presence of any medical or psycho-social issues that are likely to interfere with safe study conduct, or that may cause increased risk to subject Any medical condition or clinical laboratory abnormality that per Investigator or Medical Monitor judgement precludes safe participation in and completion of the study, or which could affect compliance with protocol conduct or interpretation of results Additional Exclusion Criteria for Regimen A: FT516 monotherapy: Diagnosis of promyelocytic leukemia with t(15:17) translocation
Protocol Fact Sheet for: 2019-0615
Protocol Abstract for: 2019-0615
Phase II study of Dose-Reduced Consolidation Radiation Therapy in Patients with Diffuse Large B-cell Lymphoma
Protocol Number: 2019-0513 Slots available for DLBCL: 21 OUT OF 30
Key Information: *RadOnc Study*
Stage I-IV only DLBCL, NOS < 10 weeks s/p at least 3 (total 3 to 6) cycles of a rituximab containing, anthracycline-based chemotherapy regimen (R-CHOP preferred but not mandated) PI: Pinnix, Chelsea Contact: Mathai, Rony
Email: HEMERadOncResearch@mdanderson.org Office Mobile: (832) 468-1765 Office Phone: (713) 794-5072
Protocol Eligibility Requirements for 2019-0513 Inclusion
Histologic documentation of stage I-IV DLBCL NOS including GCB and non GCB subtypes and those with a double expressor phenotype. Also eligible are stage I-IV HGBL with MYC and BCL2 and/or BCL6 rearrangements and HGBL, NOS. Completion of at least 3 cycles of a rituximab-containing, anthracycline-based combination. chemotherapy regimen (R-CHOP preferred but not mandated). Negative post-chemotherapy PET-CT scan or negative interim PET-CT scan performed within 2 weeks of the final cycle of chemoimmunotherapy. ANC ≥ 1000 and platelet count ≥ 40,000. Exclusion Primary CNS lymphoma, primary cutaneous DLBCL, leg type, T-cell/histiocyterich large B-cell lymphoma, primary mediastinal (thymic) large B-cell lymphoma, or other distinct non- Hodgkin lymphomas arising from large B-cells included in the WHO classification. Any absolute contraindications to irradiation.
Protocol Abstract for 2019-0513