- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02601313
Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2) (ZUMA-2)
A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study KTE-C19-102 enrolled participants with r/r MCL who have been treated with up to 5 prior regimens including a Bruton's tyrosine kinase inhibitor (BTKi) in Cohort 1 and Cohort 2. However, to fulfill FDA Postmarketing Requirement, Cohort 3 is added to the study. It will include participants with r/r MCL who have been treated with up to 5 prior regimens but have not received prior therapy with a BTKi.
The primary analysis in Cohort 1 and Cohort 2 is already completed. Data for Cohort 3 will be analyzed separately. Therefore, details for Cohort 3 were registered separately (NCT04880434) on ClinicalTrials.gov as this cohort will not be part of the main study analysis.
After the end of KTE-C19-102, subjects who received an infusion of anti-CD19 CAR T cells will complete the remainder of the 15-year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Bordeaux, France
- Centre Hospitalier Universitaire (Chu)
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Paris, France, 75010
- Hospital Saint Louis
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Pessac, France, 44035
- Hôpital Haut-Lévêque
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Dresden, Germany, 01307
- Universitatsklinik Dresden
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Wuerzburg, Germany, 97080
- Universitaetsklinikum Wuerzburg
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Amsterdam, Netherlands
- Academisch Medisch Centrum
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Groningen, Netherlands
- University Medical Center Groningen
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Rotterdam, Netherlands
- Erasmus Medical Center
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Arizona
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Gilbert, Arizona, United States, 85234
- Banner MD Anderson
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California
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Duarte, California, United States, 91010
- City of Hope
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Santa Monica, California, United States, 90404
- University California Los Angeles (UCLA)
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Stanford, California, United States, 94305
- Stanford University
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Colorado
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Denver, Colorado, United States, 80218
- Sarah Cannon
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Florida
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Miami, Florida, United States, 33136
- University of Miami
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Tampa, Florida, United States, 33612
- H Lee Moffitt Cancer Center
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Georgia
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Atlanta, Georgia, United States, 30322
- Winship Cancer Institute of Emory University
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago
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Maywood, Illinois, United States, 60153
- Loyola University Chicago
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Dana-Farber Cancer Institute
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Michigan
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Detroit, Michigan, United States, 48201
- Barbara Ann Karmanos Cancer Institute
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Hackensack University Medical Center
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New York
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Rochester, New York, United States, 14642
- University of Rochester Medical Center
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
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Columbus, Ohio, United States, 43210
- Ohio State University
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Oregon
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Portland, Oregon, United States, 97213
- Robert W. Franz Cancer Research Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
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Nashville, Tennessee, United States, 37203
- Sarah Cannon Research Institute
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Texas
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Dallas, Texas, United States, 75246
- Baylor Charles A. Sammons Cancer Center
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Houston, Texas, United States, 77030
- University of Texas MD Anderson Cancer Center
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Washington
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Seattle, Washington, United States, 98104
- Swedish Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Axicabtagene ciloleucel/brexucabtagene autoleucel (KTE-X19)
Participants with relapsed/refractory mantle cell lymphoma (MCL) will receive conditioning chemotherapy (CTE) consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day intravenous (IV) infusion for 3 days followed by a single infusion of axicabtagene ciloleucel at a targeted dose of 2 x 10^6 anti-CD19 chimeric antigen receptor (CAR) T cells/kg on Day 0 or brexucabtagene autoleucel (KTE-X19) at a targeted dose of 2 x 10^6 CAR T cells/kg, with a maximum dose of 2 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0 in Cohort 1 or brexucabtagene autoleucel at a targeted dose of 0.5 x 10^6 anti-CD19 CAR T cells/kg, with a maximum dose of 0.5 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0 in Cohort 2.
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Administered intravenously
Administered intravenously
A single infusion of brexucabtagene autoleucel (KTE-X19) anti-CD 19 CAR T cells
Other Names:
A single infusion of axicabtagene ciloleucel anti-CD 19 CAR T cells
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants With Objective Response (OR) Per the Lugano Classification According to Independent Radiology Review Committee (IRRC) in Cohort 1
Time Frame: Up to 2 years
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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.
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Up to 2 years
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Percentage of Participants With Objective Response (OR) Per the Lugano Classification According to Independent Radiology Review Committee (IRRC) in Cohort 2
Time Frame: Up to 2 years
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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.
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Up to 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Duration of Response (DOR) in Cohort 1
Time Frame: Up to 15 years
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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.
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Up to 15 years
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Duration of Response (DOR) in Cohort 2
Time Frame: Up to 15 years
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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.
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Up to 15 years
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Percentage of Participants With Best Objective Response (BOR) as Per Investigator Assessment Determined by International Working Group (IWG) 2007 Criteria in Cohort 1
Time Frame: Up to 15 years
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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.
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Up to 15 years
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Percentage of Participants With Best Objective Response (BOR) as Per Investigator Assessment Determined by Lugano Classification in Cohort 2
Time Frame: Up to 15 years
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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.
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Up to 15 years
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Percentage of Participants With Objective Response (OR) as Per Investigator Assessment Determined by International Working Group (IWG) 2007 Criteria in Cohort 1
Time Frame: Up to 15 years
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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.
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Up to 15 years
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Percentage of Participants With Objective Response (OR) as Per Investigator Assessment Determined by Lugano Classification in Cohort 2
Time Frame: Up to 15 years
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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.
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Up to 15 years
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Progression Free Survival (PFS) in Cohort 1
Time Frame: Up to 15 years
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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.
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Up to 15 years
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Progression Free Survival (PFS) in Cohort 2
Time Frame: Up to 15 years
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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.
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Up to 15 years
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Overall Survival in Cohort 1
Time Frame: Up to 15 years
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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.
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Up to 15 years
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Overall Survival in Cohort 2
Time Frame: Up to 15 years
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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.
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Up to 15 years
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Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Time Frame: Up to 15 years
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Up to 15 years
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Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade
Time Frame: Up to 15 years
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Up to 15 years
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Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade
Time Frame: Up to 15 years
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Up to 15 years
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Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade
Time Frame: Up to 15 years
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Up to 15 years
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Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade
Time Frame: Up to 15 years
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Up to 15 years
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Percentage of Participants With Anti-CD19 CAR Antibodies
Time Frame: Up to 15 years
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Up to 15 years
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Peak Anti-CD19 CAR T-Cell (Brexucabtagene Autoleucel) Level (Maximum Observed Plasma Concentration) in Blood
Time Frame: Up to 15 years
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Up to 15 years
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Peak Serum Levels of C-Reactive Protein (CRP) in Blood
Time Frame: Up to 15 years
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Up to 15 years
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Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-Gamma (IFN-γ), 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-α) in Blood
Time Frame: Up to 15 years
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Up to 15 years
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Peak Serum Levels of Ferritin, Interleukin-2 Receptor Alpha (IL-2Rα), Intercellular Adhesion Molecule-1 (ICAM-1), Perforin, Vascular Cell Adhesion Molecule-1 (VCAM-1) in Blood
Time Frame: Up to 15 years
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Up to 15 years
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Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score
Time Frame: Baseline, Week 4, Month 3, and Month 6
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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.
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Baseline, Week 4, Month 3, and Month 6
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Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score
Time Frame: Baseline, Week 4, Month 3, and Month 6
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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.
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Baseline, Week 4, Month 3, and Month 6
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Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score
Time Frame: Baseline, Week 4, Month 3, and Month 6
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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.
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Baseline, Week 4, Month 3, and Month 6
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Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score
Time Frame: Baseline, Week 4, Month 3, and Month 6
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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.
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Baseline, Week 4, Month 3, and Month 6
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Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score
Time Frame: Baseline, Week 4, Month 3, and Month 6
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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.
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Baseline, Week 4, Month 3, and Month 6
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Change Over Time in EQ-5D Visual Analogue Scale (VAS) Score
Time Frame: Baseline, Week 4, Month 3, and Month 6
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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.
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Baseline, Week 4, Month 3, and Month 6
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Kite Study Director, Kite, A Gilead Company
Publications and helpful links
General Publications
- 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 Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo Espanol de Medula Osea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. doi: 10.1200/JCO.2013.54.8800.
- 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 Oncology (ASCO) Annual Meeting 2016.
- 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 Oncology (ESMO) Congress 2016;Abstract 3305
- 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. KTE-X19 CAR T-Cell Therapy in Relapsed or Refractory Mantle-Cell Lymphoma. N Engl J Med. 2020 Apr 2;382(14):1331-1342. doi: 10.1056/NEJMoa1914347.
- 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.; Bot, Adrian
- 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, John M.(13); José Kersten, Marie(14); Peng, Weimin(15); Zheng, Lianqing(15); Rossi, John M.(15); Jain, Rajul K.(15); Rao, Arati V.(15); Reagan, Patrick M.(16)
- 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)
- 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 Noel Milpied,15 Henry Fung,16 Max S. Topp,17 Roch Houot,18 Amer Beitinjaneh,19 Weimin Peng,20 Lianqing Zheng,20 John M. Rossi,20 Rajul K. Jain,20 Arati V. Rao,20 and Patrick M. Reagan21
- 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, 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, PhD(10); McSweeney, Peter A., MD(11); Miklos, David B., MD, PhD(12); Pagel, John M., MD, PhD, DSc(13); Jose Kersten, Marie, MD, PhD(14); Peng, Weimin, MS(15); Zheng, Lianqing, PhD(15); Rossi, John M., MS(15); Jain, Rajul K., MD(15); Rao, Arati V., MD(15); Reagan, Patrick M, MD(16)
- 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 Jaglowski, Samantha; Bernard Miklos, David; Shaughnessy, Paul; Unabia, Sherry; Rossi, John M.; Jiang, Yizhou; Jain, Rajul K.
- Wang M, Jain P, Chi TL, Chen SE, Heimberger A, Weathers SP, Zheng L, Rao AV, Rossi JM. Management of a patient with mantle cell lymphoma who developed severe neurotoxicity after chimeric antigen receptor T-cell therapy in ZUMA-2. J Immunother Cancer. 2020 Oct;8(2):e001114. doi: 10.1136/jitc-2020-001114.
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Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, Mantle-Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Immunological
- Cyclophosphamide
- Fludarabine
- Axicabtagene ciloleucel
- Brexucabtagene autoleucel
Other Study ID Numbers
- KTE-C19-102
- 2015-005008-27 (EudraCT Number)
- 2023-506641-35 (Other Identifier: European Medicines Agency)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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