Relapsed/Refractory Mantle Cell Lymphoma Clinical Trial
— ZUMA-2Official title:
A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma
| Verified date | February 2024 |
| Source | Gilead Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The goal of this clinical study is to test how well the study drug, brexucabtagene autoleucel (KTE-X19), works in participants with relapsed/refractory (r/r) mantle cell lymphoma (MCL).
| Status | Completed |
| Enrollment | 105 |
| Est. completion date | September 22, 2023 |
| Est. primary completion date | July 24, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Key Inclusion Criteria: Up to 5 prior regimens for MCL. Prior therapy must have included: - Anthracycline or bendamustine-containing chemotherapy and - Anti-CD20 monoclonal antibody therapy and - Ibrutinib or acalabrutinib At least 1 measurable lesion Platelet count = 75,000/uL Creatinine clearance (as estimated by Cockcroft Gault) > or = to 60 mL/min Cardiac ejection fraction = 50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings Baseline oxygen saturation >92% on room air. Key Exclusion Criteria: - Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive). A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per standard serological and genetic testing - History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or any autoimmune disease with central nervous system (CNS) involvement - Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Note: Other protocol defined Inclusion/Exclusion criteria may apply. |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Hospitalier Universitaire (CHU) | Bordeaux | |
| France | Hospital Saint Louis | Paris | |
| France | Hopital Haut-Leveque | Pessac | |
| Germany | Universitätsklinik Dresden | Dresden | |
| Germany | Universitaetsklinikum Wuerzburg | Wuerzburg | |
| Netherlands | Academisch Medisch Centrum | Amsterdam | |
| Netherlands | University Medical Center Groningen | Groningen | |
| Netherlands | Erasmus Medical Center | Rotterdam | |
| United States | Winship Cancer Institute of Emory University | Atlanta | Georgia |
| United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
| United States | University of Chicago | Chicago | Illinois |
| United States | Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | Ohio State University | Columbus | Ohio |
| United States | Baylor Charles A. Sammons Cancer Center | Dallas | Texas |
| United States | Sarah Cannon | Denver | Colorado |
| United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
| United States | City of Hope | Duarte | California |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | Banner MD Anderson | Gilbert | Arizona |
| United States | Hackensack University Medical Center | Hackensack | New Jersey |
| United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
| United States | Loyola University Chicago | Maywood | Illinois |
| United States | University of Miami | Miami | Florida |
| United States | Sarah Cannon Research Institute | Nashville | Tennessee |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
| United States | Robert W. Franz Cancer Research Center | Portland | Oregon |
| United States | University of Rochester Medical Center | Rochester | New York |
| United States | University California Los Angeles (UCLA) | Santa Monica | California |
| United States | Swedish Cancer Institute | Seattle | Washington |
| United States | Stanford University | Stanford | California |
| United States | H Lee Moffitt Cancer Center | Tampa | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Kite, A Gilead Company |
United States, France, Germany, Netherlands,
Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organ — View Citation
Locke F, Wang M, Siddiqi T, Castro J, Shah B, Lee H, et al. ZUMA-2: A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-C19 (Anti-CD19 CAR T cells) in Subjects with Relapsed/Refractory Mantle Cell Lymphoma (r/r MCL). American Society Of Clinical On
Michael Wang,1 Javier Munoz,2 Andre Goy,3 Frederick L. Locke,4 Caron A. Jacobson,5 Brian T. Hill,6 John M. Timmerman,7 Houston Holmes,8 Samantha Jaglowski,9 Ian W. Flinn,10 Peter A. McSweeney,11 David B. Miklos,12 John M. Pagel,13 Marie José Kersten,14 No
Wang M, Locke F, Siddiqi T, Castro J, Shah B, Lee H, et al. ZUMA-2: A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-C19 (Anti-CD19 CAR T cells) in Subjects with Relapsed/Refractory Mantle Cell Lymphoma (r/r MCL). European Society for Medical On
Wang M, Locke FL, Munoz J, Goy A, Holmes HE, Siddiqi T, et al. ZUMA-2: Phase 2 Multicenter Study Evaluating Efficacy of Kte-C19 in Patients with Relapsed/Refractory Mantle Cell Lymphoma [Abstract]. J Clin Oncol 2018;36 (Suppl 15):TPS3102.
Wang M, Munoz J, Goy A, Locke FL, Jacobson CA, Hill BT, Timmerman JM, Holmes H, Jaglowski S, Flinn IW, McSweeney PA, Miklos DB, Pagel JM, Kersten MJ, Milpied N, Fung H, Topp MS, Houot R, Beitinjaneh A, Peng W, Zheng L, Rossi JM, Jain RK, Rao AV, Reagan PM — View Citation
Wang M, Munoz J, Goy A, Locke FL, Jacobson CA, Hill BT, Timmerman JM, Holmes H, Jaglowski S, Flinn IW, McSweeney PA,Miklos DB, Pagel JM, Kersten MJ, Peng W,Zheng L,Rossi JM, Jain RK, Rao AV, Reagan PM
Wang, M.(1); Munoz, J.(2); Goy, A.(3); Locke, F.(4); Jacobson, C.(5); Hill, B.(6); Timmerman, J.(7); Holmes, H.(8); Jaglowski, S.(9); Flinn, I.(10); McSweeney, P.(11); Miklos, D.(12); Pagel, J.(13); Kersten, M. J.(14)(15)
Wang, Michael L., MD(1); Munoz, Javier, MD(2); Goy, Andre, MD(3); Locke, Frederick L., MD(4); Jacobson, Caron A., MD, MMSc(5); Hill, Brian T., MD(6); Timmerman, John M., MD(7); Holmes, Houston, MD(8); Jaglowski, Samantha, MD, MPH(9); Flinn, Ian W., MD, Ph
Wang, Michael(1); Munoz, Javier(2); Goy, Andre(3); Locke, Frederick L.(4); Jacobson, Caron A.(5); Hill, Brian T.(6); Timmerman, John M.(7); Holmes, Houston(8); Jaglowski, Samantha(9); Flinn, Ian W.(10); McSweeney, Peter A.(11); Miklos, David B.(12); Pagel
Wang, Michael; Lundry Locke, Frederick; Munoz, Javier; Goy, Andre; Eccleston Holmes, Houston; Siddiqi, Tanya; Flinn, Ian; McSweeney, Peter A; Michael Reagan, Patrick; Thomas Hill, Brian; Jacobson, Caron A.; Rizzieri, David A.; Heffner, Leonard T.; Mary Ja
Wang, Michael; Rossi, John M.; Munoz, Javier; Goy, Andre; Lundry Locke, Frederick; Michael Reagan, Patrick; Jacobson, Caron A.; Hill, Brian T; Holmes, Houston; Mary Jaglowski, Samantha; Peng, Weimin; Zheng, Lianqing; Fang, Xiang; Xue, Allen; Rao, Arati V.
* Note: There are 12 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With Objective Response (OR) Per the Lugano Classification According to Independent Radiology Review Committee (IRRC) in Cohort 1 | OR: complete metabolic response(CMR),complete radiological response(CRR),partial MR response(PMR),partial RR(PRR).CMR:score 1(no uptake above background)/2(uptake = mediastinum)/3(uptake > mediastinum but = liver)with/without a residual mass on positron emission tomography 5-point scale;no new lesions.CRR:target nodes/nodal masses regressed to = 1.5 cm in longest transverse diameter of lesion(LDi);no extralymphatic sites of disease;absent non-measured lesion(NMLs);organ enlargement regress to normal;no new sites;bone marrow normal by morphology. PMR:score 4(uptake moderately > liver)/5(uptake markedly > liver, new lesions)with reduced uptake compared with baseline and residual mass;no new lesions;responding disease at interim/residual disease at end of treatment (EOT).PRR: = 50% decrease in sum of the product of the diameters(SPD)of up to 6 target measurable nodes and extra-nodal sites;absent/normal, regressed, but no increase of NMLs;spleen regressed by > 50% in length beyond normal. | Up to 2 years | |
| Primary | Percentage of Participants With Objective Response (OR) Per the Lugano Classification According to Independent Radiology Review Committee (IRRC) in Cohort 2 | OR: CMR, CRR, PMR, PRR. CMR: score 1(no uptake above background) / 2(uptake = mediastinum) / 3(uptake > mediastinum but = liver) with/without a residual mass on positron emission tomography 5-point scale; no new lesions. CRR: target nodes/nodal masses regressed to = 1.5 cm in LDi; no extralymphatic sites of disease;absent non-measured lesion NMLs; organ enlargement regress to normal; no new sites; bone marrow normal by morphology. PMR: score 4(uptake moderately > liver) /5 (uptake markedly > liver, new lesions) with reduced uptake compared with baseline and residual mass; no new lesions; responding disease at interim/residual disease at EOT. PRR: = 50% decrease in SPD of up to 6 target measurable nodes and extra-nodal sites; absent/normal, regressed, but no increase of NMLs; spleen regressed by > 50% in length beyond normal. | Up to 2 years | |
| Secondary | Duration of Response (DOR) in Cohort 1 | DOR: time from the first OR to progressive disease (PD)/death. It is determined using Kaplan-Meier (KM) estimates. PD: score 4 (uptake moderately > liver)/ 5 (uptake markedly >liver and/or new lesions) with an increase in intensity of uptake from baseline; new fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma at interim/EOT assessment; new FDG-avid foci consistent with lymphoma rather than another etiology; new/recurrent FDG-avid foci in bone marrow; an individual node/lesion must be abnormal with: LDi > 1.5 cm, increase by = 50% from cross-product of LDi and perpendicular diameter (PPD) nadir, increase in LDi or shortest axis perpendicular to the LDi from nadir, the splenic length must increase by > 50% of the extent of its prior increase beyond baseline. If no prior splenomegaly, the increase must be = 2 cm from baseline; new/recurrent splenomegaly; new or clear progression of pre-existing NMLs; new lesion; new/recurrent bone marrow involvement. | Up to 15 years | |
| Secondary | Duration of Response (DOR) in Cohort 2 | DOR: time from the first OR to PD/death. It is determined using KM estimates. PD: score 4 (uptake moderately > liver)/5 (uptake markedly >liver and/or new lesions) with an increase in intensity of uptake from baseline; new FDG-avid foci consistent with lymphoma at interim/EOT assessment; new FDG-avid foci consistent with lymphoma rather than another etiology; new/recurrent FDG-avid foci in bone marrow; an individual node/lesion must be abnormal with: LDi > 1.5 cm, increase by = 50% from cross-product of LDi and PPD nadir, increase in LDi or shortest axis perpendicular to the LDi from nadir, the splenic length must increase by > 50% of the extent of its prior increase beyond baseline. If no prior splenomegaly, the increase must be = 2 cm from baseline; new/recurrent splenomegaly; new or clear progression of pre-existing NMLs; new lesion; new/recurrent bone marrow involvement. | Up to 15 years | |
| Secondary | Percentage of Participants With Best Objective Response (BOR) as Per Investigator Assessment Determined by International Working Group (IWG) 2007 Criteria in Cohort 1 | BOR consists of (Complete response [CR], Partial response [PR], stable disease [SD], progressive disease [PD] and unknown). CR: disappearance of all detectable clinical evidence; PR: 50% decrease in the sum of the product of diameters (SPD) of up to 6 largest dominant nodal masses and >= 50% decrease in SPD of spleen/liver nodules; PD: appearance of any new lesions or >= 50% increase in SPD of more than one node or >= 50% increase in longest diameter of a previously identified node or >50% increase from nadir in the SPD of any previous lesions; SD: failure to attain CR/PR or PD. | Up to 15 years | |
| Secondary | Percentage of Participants With Best Objective Response (BOR) as Per Investigator Assessment Determined by Lugano Classification in Cohort 2 | BOR consists of CR (CMR/CRR), PR (PMR/PRR), SD, PD and not done. CMR/CRR and PMR/PRR are defined in Outcome Measure (OM) 1. PD is defined in OM 3. SD/no metabolic response (NMR): a score 4 (uptake moderately greater than [>] liver) or 5 (uptake markedly >liver and/ or new lesions) with no significant change in FDG uptake compared to baseline (screening), at an interim time point or end of treatment; no new sites of disease should be observed.Not done: no assessment at the time of analysis. | Up to 15 years | |
| Secondary | Percentage of Participants With Objective Response (OR) as Per Investigator Assessment Determined by International Working Group (IWG) 2007 Criteria in Cohort 1 | OR: CR or PR. CR: disappearance of all detectable clinical evidence; typically FDG-avid lymphoma (a post-treatment residual mass of any size is permitted if it is PET negative); variably FDG-avid lymphomas/FDG avidity unknown (all lymph nodes and nodal masses must have regressed to normal size); spleen and/or liver should be normal size and not be palpable; bone marrow aspirate and biopsy must show no evidence of disease. PR: 50% decrease in the SPD of up to 6 largest dominant nodal masses and = 50% decrease in SPD of spleen/liver nodules; no increase in size of nodes, liver, or spleen and no new sites of disease; splenic and hepatic nodules must regress by = 50% in the SPD; if participant has persistent bone marrow involvement and otherwise meets criteria for CR, will then be considered a PR; typically FDG-avid lymphoma (the post-treatment PET scan should be positive in at least 1 previously involved site. | Up to 15 years | |
| Secondary | Percentage of Participants With Objective Response (OR) as Per Investigator Assessment Determined by Lugano Classification in Cohort 2 | OR: CMR, CRR, PMR, PRR. CMR: score 1(no uptake above background) / 2(uptake = mediastinum) / 3(uptake > mediastinum but = liver) with/without a residual mass on positron emission tomography 5-point scale; no new lesions. CRR: target nodes/nodal masses regressed to = 1.5 cm in LDi ;no extralymphatic sites of disease;absent NMLs; organ enlargement regress to normal; no new sites;bone marrow normal by morphology. PMR: score 4 (uptake moderately > liver) /5 (uptake markedly > liver, new lesions) with reduced uptake compared with baseline and residual mass; no new lesions; responding disease at interim/residual disease at EOT. PRR: = 50% decrease in SPD of up to 6 target measurable nodes and extra-nodal sites;absent/normal, regressed, but no increase of NMLs; spleen regressed by > 50% in length beyond normal. | Up to 15 years | |
| Secondary | Progression Free Survival (PFS) in Cohort 1 | PFS was defined as the time from the brexucabtagene autoleucel infusion date to the date of PD or death from any cause. PD: a score 4 (uptake moderately > liver) or 5 (uptake markedly >liver and/or new lesions) with an increase in intensity of uptake from baseline; new FDG-avid foci consistent with lymphoma at interim or end of treatment assessment; new FDG-avid foci consistent with lymphoma rather than another etiology (eg, infection, inflammation); new or recurrent FDG-avid foci in bone marrow. PFS was determined using the KM estimates. | Up to 15 years | |
| Secondary | Progression Free Survival (PFS) in Cohort 2 | PFS was defined as the time from the brexucabtagene autoleucel infusion date to the date of PD or death from any cause. PD: a score 4 (uptake moderately > liver) or 5 (uptake markedly >liver and/or new lesions) with an increase in intensity of uptake from baseline; new FDG-avid foci consistent with lymphoma at interim or end of treatment assessment; new FDG-avid foci consistent with lymphoma rather than another etiology (eg, infection, inflammation); new or recurrent FDG-avid foci in bone marrow. PFS was determined using the KM estimates. | Up to 15 years | |
| Secondary | Overall Survival in Cohort 1 | Overall survival was defined as the time from brexucabtagene autoleucel infusion to the date of death from any cause. Overall survival was determined using the KM estimates. | Up to 15 years | |
| Secondary | Overall Survival in Cohort 2 | Overall survival was defined as the time from brexucabtagene autoleucel infusion to the date of death from any cause. Overall survival was determined using the KM estimates. | Up to 15 years | |
| Secondary | Percentage of Participants Experiencing Treatment-Emergent Adverse Events | Up to 15 years | ||
| Secondary | Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade | Up to 15 years | ||
| Secondary | Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade | Up to 15 years | ||
| Secondary | Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade | Up to 15 years | ||
| Secondary | Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade | Up to 15 years | ||
| Secondary | Percentage of Participants With Anti-CD19 CAR Antibodies | Up to 15 years | ||
| Secondary | Peak Anti-CD19 CAR T-Cell (Brexucabtagene Autoleucel) Level (Maximum Observed Plasma Concentration) in Blood | Up to 15 years | ||
| Secondary | Peak Serum Levels of C-Reactive Protein (CRP) in Blood | Up to 15 years | ||
| Secondary | Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-Gamma (IFN-?), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-7, IL-8,IL-10, IL-15, and Tumor Necrosis Factor-Alpha (TNF-a) in Blood | Up to 15 years | ||
| Secondary | Peak Serum Levels of Ferritin, Interleukin-2 Receptor Alpha (IL-2Ra), Intercellular Adhesion Molecule-1 (ICAM-1), Perforin, Vascular Cell Adhesion Molecule-1 (VCAM-1) in Blood | Up to 15 years | ||
| Secondary | Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score | The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant is asked for a three-level assessment of their health on the current day: "no problems" (1), "some problems" (2), "extreme problems" (3). EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state). Positive numbers indicate improvement from baseline. The percentage of participants with each level of problem are reported. | Baseline, Week 4, Month 3, and Month 6 | |
| Secondary | Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score | The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant is asked for a three-level assessment of their health on the current day: "no problems" (1), "some problems" (2), "extreme problems" (3). EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state). Positive numbers indicate improvement from baseline. The percentage of participants with each level of problem are reported. | Baseline, Week 4, Month 3, and Month 6 | |
| Secondary | Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score | The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant is asked for a three-level assessment of their health on the current day: "no problems" (1), "some problems" (2), "extreme problems" (3). EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state). Positive numbers indicate improvement from baseline. The percentage of participants with each level of problem are reported. | Baseline, Week 4, Month 3, and Month 6 | |
| Secondary | Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score | The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant is asked for a three-level assessment of their health on the current day: "no problems" (1), "some problems" (2), "extreme problems" (3). EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state). Positive numbers indicate improvement from baseline. The percentage of participants with each level of problem are reported. | Baseline, Week 4, Month 3, and Month 6 | |
| Secondary | Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score | The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant is asked for a three-level assessment of their health on the current day: "no problems" (1), "some problems" (2), "extreme problems" (3). EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state). Positive numbers indicate improvement from baseline. The Percentage of participants with each level of problem are reported. | Baseline, Week 4, Month 3, and Month 6 | |
| Secondary | Change Over Time in EQ-5D Visual Analogue Scale (VAS) Score | EQ-5D is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-consists of two components: a health state profile and an optional visual analogue scale (VAS). The EQ5D-VAS records the participant's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. EQ-5D-VAS: range 0 to 100. A higher score indicates better self-reported health status. A positive change indicates an improvement. | Baseline, Week 4, Month 3, and Month 6 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06253663 -
Study of KTE-X19 in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
|
Phase 2 | |
| Completed |
NCT01838434 -
Lenalidomide With or Without Idelalisib in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma
|
Phase 1 | |
| Completed |
NCT03886831 -
A Study of PRT543 in Participants With Advanced Solid Tumors and Hematologic Malignancies
|
Phase 1 | |
| Active, not recruiting |
NCT04880434 -
Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 3)
|
Phase 2 | |
| Completed |
NCT02460276 -
A Trial of Ibrutinib, Lenalidomide and Rituximab for Patients With Relapsed/Refractory Mantle Cell Lymphoma
|
Phase 2 |