Back to resultsLisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006)
Primary Purpose
Lymphoma, Non-Hodgkin, Lymphoma, Nonhodgkin, Lymphoma, B-Cell
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
lisocabtagene maraleucel
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring JCAR017, lisocabtagene maraleucel, NHL, chimeric antigen receptor, CAR, CAR T cell, autologous T cell therapy, immunotherapy, cell therapy, liso-cel
Eligibility Criteria
Inclusion Criteria:
- Confirmation of relapsed or refractory aggressive B-cell non-Hodgkin lymphoma of the following histology at relapse: diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS; de novo or transformed follicular lymphoma [tFL]), high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double/triple hit lymphoma [DHL/THL]), and follicular lymphoma Grade 3B per WHO 2016 classification
- Previous treatment must include treatment with a single line of chemoimmunotherapy containing an anthracycline and a CD20-targeted agent
- Subjects must be deemed ineligible for both high-dose chemotherapy and hematopoietic stem cell transplant (based on age, performance status and/or comorbidities) while also having adequate organ function for CAR T cell treatment.
- Positron emission tomography (PET)-positive disease
- Histological confirmation of diagnosis at last relapse. Enough tumor material must be available for central confirmation of diagnosis, otherwise a new tumor biopsy is mandated.
- ECOG performance status of 0, or 1, or 2
- Adequate vascular access for leukapheresis procedure (either peripheral line or surgically-placed line)
- Subjects must agree to use appropriate contraception
- Subjects must agree to not donate blood, organs, semen, and egg cells for usage in other individuals for at least 1 year following lymphodepleting chemotherapy
Exclusion Criteria:
- Subjects with central nervous system (CNS)-only involvement by malignancy (note: subjects with secondary CNS involvement are allowed on study)
- History of another primary malignancy that has not been in remission for at least 2 years.
- Previous treatment with CD19-targeted therapy, with the exception of prior lisocabtagene maraleucel treatment in this protocol for subjects receiving retreatment
- Active hepatitis B or hepatitis C infection at the time of screening
- History of or active human immunodeficiency virus (HIV) infection at the time of screening
- Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of leukapheresis or lisocabtagene maraleucel administration
- History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association, cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease
- History or presence of clinically relevant CNS pathology
- Pregnant or nursing women
- Subject does not meet protocol-specified washout periods for prior treatments
- Prior hematopoietic stem cell transplant
- Progressive vascular tumor invasion, thrombosis, or embolism
- Venous thrombosis or embolism not managed on stable regimen of anticoagulation
- Uncontrolled medical, psychological, familial, sociological, or geographical conditions
Sites / Locations
- Banner MD Anderson Cancer Center
- Scripps Clinic
- UNC School of Medicine
- University of California Los Angeles
- Sutter Hematology and Oncology
- Sutter Medical Center
- Stanford Cancer Genetics Clinic
- Stanford Cancer Center
- The Blood and Marrow Transplant Group of Georgia
- UNC School of Medicine
- Northwestern University Feinberg School of Medicine
- Northwestern University
- University of Chicago
- University of Chicago Comprehensive Cancer Center
- University of Kentucky/Markey Cancer Center
- University of Kentucky
- Norton Cancer Institute - Brownsboro
- UNC School of Medicine
- Johns Hopkins Oncology Center Bunting Blaustein Building
- The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Regional Cancer Care Associates
- UNC School of Medicine
- New York Oncology Hematology - Albany Cancer Center
- New York Oncology Hematology P.C.
- University of Rochester Cancer Center
- University of Rochester Medical Center
- Levine Cancer Institute
- Oncology Hematology Care, Inc.
- Oncology Hematology Care
- Local Institution - 0051
- Providence Cancer Center/Earle A. Chiles Res. Inst.
- Providence Portland Medical Center
- University of Pittsburgh Medical Center Hillman Cancer Center
- Greenville Health System - Cancer Institute - Faris Road
- Greenville Health System
- Local Institution - 0083
- UNC School of Medicine
- Intermountain Healthcare - LDS Hospital Blood and Marrow Transplant
- Intermountain Healthcare - LDS Hospital
- Northwest Medical Specialties
- UNC School of Medicine
- Medical College of Wisconsin, Froedtert Hospital
- UNC School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Lisocabtagene maraleucel at a dose of 100×10^6 CAR+ T cells (50×10^6 CD8+ CAR+ T cells and 50×10^6 CD4+ CAR+ T cells), will be given IV in a single-dose schedule on Day 1 (between 2 and 7 days following the completion of lymphodepleting chemotherapy).
Outcomes
Primary Outcome Measures
Overall Response Rate (ORR)
Overall response rate is the percent of participants with a best overall response (BOR) of either complete response (CR) or partial reasons (PR) based on the Independent Review Committee (IRC) assessment recorded from the time of JCAR017 treatment until disease progression, end of study, the start of another anticancer therapy or JCAR017 retreatment.
CR = Score 1, 2, or 3 with or without a residual mass on the positron emission tomography 5-point scale (PET 5PS). A score of 3 in many patients indicates a good prognosis with standard treatment.
PR = Score 4 or 5b with reduced uptake compared with baseline and residual mass(es) of any size.
PET 5PS = 1- no uptake above background; 2- uptake ≤ mediastinum; 3- uptake > mediastinum but ≤ liver; 4- uptake moderately > liver; 5- uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.
Secondary Outcome Measures
Number of Participants With Any Treatment-Emergent Adverse Events (TEAEs)
A TEAE was defined as an adverse event that started any time from initiation of product administration through and including 90 days following product administration. AEs that occurred after the initiation of subsequent anticancer therapy or product retreatment were not considered as product TEAE. AEs are graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (Version 4.03) (NCI CTCAE) guidelines where Grade 3= Severe, Grade 4= Life-threatening, and 5 = Death.
Change From Baseline of Hematology Laboratory Results: Hemoglobin
Change from baseline in Hematology laboratory analysis. Includes Hemoglobin. Baseline is the last observation collected prior to or on the date of product infusion.
Change From Baseline of Hematology Laboratory Results: Leukocytes, Lymphocytes, Neutrophils, Platelets
Change from baseline in Hematology laboratory analysis. Includes Leukocytes, Lymphocytes, Neutrophils, and Platelets. Baseline is the last observation collected prior to or on the date of product infusion.
Change From Baseline of Chemistry Laboratory Results: Albumin
Change from baseline in Chemistry laboratory analysis. Includes Albumin. Baseline is the last observation collected prior to or on the date of product infusion.
Change From Baseline of Chemistry Laboratory Results: Alanine Aminotransferase, Aspartate Aminotransferase, Lactate Dehydrogenase
Change from baseline in Chemistry laboratory analysis. Includes Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase. Baseline is the last observation collected prior to or on the date of product infusion.
Change From Baseline of Chemistry Laboratory Results: Bilirubin, Creatinine, Direct Bilirubin, Urate
Change from baseline in Chemistry laboratory analysis. Includes Bilirubin, Creatinine, Direct Bilirubin, and Urate. Baseline is the last observation collected prior to or on the date of product infusion.
Change From Baseline of Chemistry Laboratory Results: Calcium Corrected, Magnesium, Phosphate, Potassium, Sodium
Change from baseline in Chemistry laboratory analysis. Includes Calcium Corrected, Magnesium, Phosphate, Potassium, and Sodium. Baseline is the last observation collected prior to or on the date of product infusion.
Complete Response (CR) Rate
Complete response rate (CRR) was defined as the percent of participants with a best overall response (BOR) of complete response (CR) based on the Independent Review Committee (IRC) assessment recorded from the time of JCAR017 treatment until disease progression, end of study, the start of another anticancer therapy or JCAR017 retreatment.
CR = Score 1, 2, or 3 with or without a residual mass on the positron emission tomography 5-point scale (PET 5PS). A score of 3 in many patients indicates a good prognosis with standard treatment.
PET 5PS = 1- no uptake above background; 2- uptake ≤ mediastinum; 3- uptake > mediastinum but ≤ liver; 4- uptake moderately > liver; 5- uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.
Duration of Response (DOR)
Duration of response (DOR) is defined as the time from first complete response(CR) or partial response (PR) to progressive disease (PD) or death, whichever occurred first.
CR = Score 1, 2, or 3 on the positron emission tomography 5-point scale (PET 5PS). A score of 3 indicates a good prognosis with standard treatment.
PR = Score 4 or 5b with reduced uptake compared with baseline and residual mass(es) of any size.
PD = Score 4 or 5b on PET 5PS with an increase in intensity of uptake from baseline and/or new fluorodeoxyglucose-avid foci consistent with lymphoma at interim or end-of-treatment assessment.
PET 5PS = 1-no uptake above background; 2-uptake ≤ mediastinum; 3-uptake > mediastinum but ≤ liver; 4-uptake moderately > liver; 5-uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.
Duration of Response (DOR) in Participants With Complete Response (CR)
DOR for participants with a best overall response of CR was defined as the time from documentation of first response (or CR) to progressive disease (PD) or death, whichever occurred first. The first documentation of CR/PR is the latest of all dates of required measurements to establish the response. The progression date is the earliest date of all assessments that led to a response assessment of PD.
CR = Score 1, 2, or 3 on the positron emission tomography 5-point scale (PET 5PS). A score of 3 indicates a good prognosis with standard treatment.
PD = Score 4 or 5b on PET 5PS with an increase in intensity of uptake from baseline and/or new fluorodeoxyglucose-avid foci consistent with lymphoma at interim or end-of-treatment assessment.
PET 5PS = 1-no uptake above background; 2-uptake ≤ mediastinum; 3-uptake > mediastinum but ≤ liver; 4-uptake moderately > liver; 5-uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.
Progression-Free Survival (PFS)
PFS is defined as the time from JCAR017 infusion to progressive disease (PD) or death. Kaplan-Meier (KM) methodology will be used to analyze PFS.
PD = Score 4 or 5b on the positron emission tomography 5-point scale (PET 5PS) with an increase in intensity of uptake from baseline and/or new fluorodeoxyglucose-avid foci consistent with lymphoma at interim or end-of-treatment assessment.
PET 5PS = 1- no uptake above background; 2- uptake ≤ mediastinum; 3- uptake > mediastinum but ≤ liver; 4- uptake moderately > liver; 5- uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.
Event-Free Survival (EFS)
EFS is defined as the time from JCAR017 infusion to the earliest of the following events: death from any cause, progressive disease (PD), or starting a new anticancer therapy. Kaplan-Meier (KM) methodology will be used to analyze EFS.
PD = Score 4 or 5b on PET 5PS with an increase in intensity of uptake from baseline and/or new fluorodeoxyglucose-avid foci consistent with lymphoma at interim or end-of-treatment assessment.
PET 5PS = 1-no uptake above background; 2-uptake ≤ mediastinum; 3-uptake > mediastinum but ≤ liver; 4-uptake moderately > liver; 5-uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.
Overall Survival (OS)
OS is defined as the time from JCAR017 infusion to the date of death. Kaplan-Meier (KM) methodology will be used to analyze OS.
PK Parameters of JCAR017 in Blood as Assessed by qPCR: Cmax
Pharmacokinetic (PK) analyses were based on quantitative polymerase chain reaction (qPCR).
Cmax = Maximum observed blood concentration.
PK Parameters of JCAR017 in Blood as Assessed by qPCR: Tmax
Pharmacokinetic (PK) analyses were based on quantitative polymerase chain reaction (qPCR). Tmax = Time of maximum observed blood concentration.
PK Parameters of JCAR017 in Blood as Assessed by qPCR: AUC (0-28)
Pharmacokinetic (PK) analyses were based on quantitative polymerase chain reaction (qPCR). AUC (0-28) = Area under the curve for concentration.
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Fatigue Subscale
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
Symptom scale/item higher score represents a high level of symptomatic problem.
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Physical Functioning Subscale
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Cognitive Functioning Subscale
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Global Health/QoL Subscale
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Role Functioning Subscale
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Emotional Functioning Subscale
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Social Functioning Subscale
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Pain Subscale
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
Symptom scale/item higher score represents a high level of symptomatic problem.
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Nausea/Vomiting Subscale
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
Symptom scale/item higher score represents a high level of symptomatic problem.
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Constipation Subscale
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
Symptom scale/item higher score represents a high level of symptomatic problem.
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Diarrhea Subscale
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
Symptom scale/item higher score represents a high level of symptomatic problem.
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Insomnia Subscale
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
Symptom scale/item higher score represents a high level of symptomatic problem.
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Dyspnea Subscale
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
Symptom scale/item higher score represents a high level of symptomatic problem.
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Appetite Loss Subscale
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
Symptom scale/item higher score represents a high level of symptomatic problem.
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Financial Difficulties Subscale
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.
Health-Related Quality of Life (HRQoL) Assessed by the FACT-Lym Subscale
The Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) consists of the FACT-General scale and a 15-item lymphoma-specific additional concerns subscale (LYM). This scale addresses symptoms and functional limitations that are important to lymphoma patients. The LYM items are scored on a 0 ("Not at all") to 4 ("Very much") response scale. Items are aggregated to a single score on a 0-60 scale.
Health-Related Quality of Life (HRQoL) Assessed by the EuroQol Instrument EQ-5D-5L
The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. These health states are converted to a single index value using the crosswalk method to the EQ-5D-3L value set from the United Kingdom (UK). The EQ-5D-5L health states ranged from -.594 for the worst (55555) to 1 for the best (11111) for UK value set with an optimal health state is assigned a score of 1.00, death is assigned a score of 0.00 and negative values representing values as worse than dead. A change of .08 is considered to be a clinically meaningful change in health utility.
Numbers of Intensive Care Unit (ICU) Inpatient Days
The numbers of ICU inpatient days.
Numbers of Non-intensive Care Unit (ICU) Inpatient Days
Number of non-ICU inpatient days.
The Number of Participants That Were Hospitalized For Adverse Events, Prophylaxis, Other
Length of hospitalization stay was reported for up to 24 months post liso-cel infusion. Reasons for hospitalization include adverse events, prophylaxis, and other. Adverse events were reported for up to 90 days post liso-cel infusion.
Full Information
NCT ID
NCT03483103
First Posted
March 23, 2018
Last Updated
January 11, 2023
Sponsor
Juno Therapeutics, a Subsidiary of Celgene
1. Study Identification
Unique Protocol Identification Number
NCT03483103
Brief Title
Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006)
Official Title
A Phase 2 Study of Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy in Adult Patients With Aggressive B-cell NHL (017006)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 26, 2018 (Actual)
Primary Completion Date
September 24, 2021 (Actual)
Study Completion Date
December 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Juno Therapeutics, a Subsidiary of Celgene
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a Phase 2, open-label, multicenter study to determine the efficacy and safety of lisocabtagene maraleucel (JCAR017) in adult subjects who have relapsed from, or are refractory to, a single line of immunochemotherapy for aggressive B-cell non-Hodgkin lymphoma (NHL) and are ineligible for hematopoietic stem cell transplant (based on age, performance status, and/or comorbidities). Subjects will receive treatment with lisocabtagene maraleucel and will be followed for 2 years for safety, pharmacokinetics and biomarkers, disease status, quality of life, and survival.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin, Lymphoma, Nonhodgkin, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse
Keywords
JCAR017, lisocabtagene maraleucel, NHL, chimeric antigen receptor, CAR, CAR T cell, autologous T cell therapy, immunotherapy, cell therapy, liso-cel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Lisocabtagene maraleucel at a dose of 100×10^6 CAR+ T cells (50×10^6 CD8+ CAR+ T cells and 50×10^6 CD4+ CAR+ T cells), will be given IV in a single-dose schedule on Day 1 (between 2 and 7 days following the completion of lymphodepleting chemotherapy).
Intervention Type
Biological
Intervention Name(s)
lisocabtagene maraleucel
Other Intervention Name(s)
JCAR017, liso-cel
Intervention Description
lisocabtagene maraleucel will be administered as a single dose intravenous (IV) injection
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
Overall response rate is the percent of participants with a best overall response (BOR) of either complete response (CR) or partial reasons (PR) based on the Independent Review Committee (IRC) assessment recorded from the time of JCAR017 treatment until disease progression, end of study, the start of another anticancer therapy or JCAR017 retreatment.
CR = Score 1, 2, or 3 with or without a residual mass on the positron emission tomography 5-point scale (PET 5PS). A score of 3 in many patients indicates a good prognosis with standard treatment.
PR = Score 4 or 5b with reduced uptake compared with baseline and residual mass(es) of any size.
PET 5PS = 1- no uptake above background; 2- uptake ≤ mediastinum; 3- uptake > mediastinum but ≤ liver; 4- uptake moderately > liver; 5- uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.
Time Frame
From first dose to disease progression, end of study, the start of another anticancer therapy, or hematopoietic stem cell transplantation (up to approximately 24 months)
Secondary Outcome Measure Information:
Title
Number of Participants With Any Treatment-Emergent Adverse Events (TEAEs)
Description
A TEAE was defined as an adverse event that started any time from initiation of product administration through and including 90 days following product administration. AEs that occurred after the initiation of subsequent anticancer therapy or product retreatment were not considered as product TEAE. AEs are graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (Version 4.03) (NCI CTCAE) guidelines where Grade 3= Severe, Grade 4= Life-threatening, and 5 = Death.
Time Frame
From first dose to 90 days following first dose (up to approximately 90 days)
Title
Change From Baseline of Hematology Laboratory Results: Hemoglobin
Description
Change from baseline in Hematology laboratory analysis. Includes Hemoglobin. Baseline is the last observation collected prior to or on the date of product infusion.
Time Frame
Baseline and Day 29
Title
Change From Baseline of Hematology Laboratory Results: Leukocytes, Lymphocytes, Neutrophils, Platelets
Description
Change from baseline in Hematology laboratory analysis. Includes Leukocytes, Lymphocytes, Neutrophils, and Platelets. Baseline is the last observation collected prior to or on the date of product infusion.
Time Frame
Baseline and Day 29
Title
Change From Baseline of Chemistry Laboratory Results: Albumin
Description
Change from baseline in Chemistry laboratory analysis. Includes Albumin. Baseline is the last observation collected prior to or on the date of product infusion.
Time Frame
Baseline and Day 29
Title
Change From Baseline of Chemistry Laboratory Results: Alanine Aminotransferase, Aspartate Aminotransferase, Lactate Dehydrogenase
Description
Change from baseline in Chemistry laboratory analysis. Includes Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase. Baseline is the last observation collected prior to or on the date of product infusion.
Time Frame
Baseline and Day 29
Title
Change From Baseline of Chemistry Laboratory Results: Bilirubin, Creatinine, Direct Bilirubin, Urate
Description
Change from baseline in Chemistry laboratory analysis. Includes Bilirubin, Creatinine, Direct Bilirubin, and Urate. Baseline is the last observation collected prior to or on the date of product infusion.
Time Frame
Baseline and Day 29
Title
Change From Baseline of Chemistry Laboratory Results: Calcium Corrected, Magnesium, Phosphate, Potassium, Sodium
Description
Change from baseline in Chemistry laboratory analysis. Includes Calcium Corrected, Magnesium, Phosphate, Potassium, and Sodium. Baseline is the last observation collected prior to or on the date of product infusion.
Time Frame
Baseline and Day 29
Title
Complete Response (CR) Rate
Description
Complete response rate (CRR) was defined as the percent of participants with a best overall response (BOR) of complete response (CR) based on the Independent Review Committee (IRC) assessment recorded from the time of JCAR017 treatment until disease progression, end of study, the start of another anticancer therapy or JCAR017 retreatment.
CR = Score 1, 2, or 3 with or without a residual mass on the positron emission tomography 5-point scale (PET 5PS). A score of 3 in many patients indicates a good prognosis with standard treatment.
PET 5PS = 1- no uptake above background; 2- uptake ≤ mediastinum; 3- uptake > mediastinum but ≤ liver; 4- uptake moderately > liver; 5- uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.
Time Frame
From first dose to disease progression, end of study, the start of another anticancer therapy, or hematopoietic stem cell transplant (up to approximately 24 months)
Title
Duration of Response (DOR)
Description
Duration of response (DOR) is defined as the time from first complete response(CR) or partial response (PR) to progressive disease (PD) or death, whichever occurred first.
CR = Score 1, 2, or 3 on the positron emission tomography 5-point scale (PET 5PS). A score of 3 indicates a good prognosis with standard treatment.
PR = Score 4 or 5b with reduced uptake compared with baseline and residual mass(es) of any size.
PD = Score 4 or 5b on PET 5PS with an increase in intensity of uptake from baseline and/or new fluorodeoxyglucose-avid foci consistent with lymphoma at interim or end-of-treatment assessment.
PET 5PS = 1-no uptake above background; 2-uptake ≤ mediastinum; 3-uptake > mediastinum but ≤ liver; 4-uptake moderately > liver; 5-uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.
Time Frame
From first dose to up to approximately 24 months
Title
Duration of Response (DOR) in Participants With Complete Response (CR)
Description
DOR for participants with a best overall response of CR was defined as the time from documentation of first response (or CR) to progressive disease (PD) or death, whichever occurred first. The first documentation of CR/PR is the latest of all dates of required measurements to establish the response. The progression date is the earliest date of all assessments that led to a response assessment of PD.
CR = Score 1, 2, or 3 on the positron emission tomography 5-point scale (PET 5PS). A score of 3 indicates a good prognosis with standard treatment.
PD = Score 4 or 5b on PET 5PS with an increase in intensity of uptake from baseline and/or new fluorodeoxyglucose-avid foci consistent with lymphoma at interim or end-of-treatment assessment.
PET 5PS = 1-no uptake above background; 2-uptake ≤ mediastinum; 3-uptake > mediastinum but ≤ liver; 4-uptake moderately > liver; 5-uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.
Time Frame
From first dose to up to approximately 24 months
Title
Progression-Free Survival (PFS)
Description
PFS is defined as the time from JCAR017 infusion to progressive disease (PD) or death. Kaplan-Meier (KM) methodology will be used to analyze PFS.
PD = Score 4 or 5b on the positron emission tomography 5-point scale (PET 5PS) with an increase in intensity of uptake from baseline and/or new fluorodeoxyglucose-avid foci consistent with lymphoma at interim or end-of-treatment assessment.
PET 5PS = 1- no uptake above background; 2- uptake ≤ mediastinum; 3- uptake > mediastinum but ≤ liver; 4- uptake moderately > liver; 5- uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.
Time Frame
From first dose to progressive disease (PD) or death (up to approximately 24 months)
Title
Event-Free Survival (EFS)
Description
EFS is defined as the time from JCAR017 infusion to the earliest of the following events: death from any cause, progressive disease (PD), or starting a new anticancer therapy. Kaplan-Meier (KM) methodology will be used to analyze EFS.
PD = Score 4 or 5b on PET 5PS with an increase in intensity of uptake from baseline and/or new fluorodeoxyglucose-avid foci consistent with lymphoma at interim or end-of-treatment assessment.
PET 5PS = 1-no uptake above background; 2-uptake ≤ mediastinum; 3-uptake > mediastinum but ≤ liver; 4-uptake moderately > liver; 5-uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.
Time Frame
From first dose to death from any cause, progressive disease (PD), or starting a new anticancer therapy (up to approximately 24 months)
Title
Overall Survival (OS)
Description
OS is defined as the time from JCAR017 infusion to the date of death. Kaplan-Meier (KM) methodology will be used to analyze OS.
Time Frame
From first dose to date of death (up to approximately 24 months)
Title
PK Parameters of JCAR017 in Blood as Assessed by qPCR: Cmax
Description
Pharmacokinetic (PK) analyses were based on quantitative polymerase chain reaction (qPCR).
Cmax = Maximum observed blood concentration.
Time Frame
From first dose to up to 24 months
Title
PK Parameters of JCAR017 in Blood as Assessed by qPCR: Tmax
Description
Pharmacokinetic (PK) analyses were based on quantitative polymerase chain reaction (qPCR). Tmax = Time of maximum observed blood concentration.
Time Frame
From first dose to up to 24 months
Title
PK Parameters of JCAR017 in Blood as Assessed by qPCR: AUC (0-28)
Description
Pharmacokinetic (PK) analyses were based on quantitative polymerase chain reaction (qPCR). AUC (0-28) = Area under the curve for concentration.
Time Frame
From first dose to up to 24 months
Title
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Fatigue Subscale
Description
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
Symptom scale/item higher score represents a high level of symptomatic problem.
Time Frame
Baseline and Day 29
Title
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Physical Functioning Subscale
Description
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.
Time Frame
Baseline and Day 29
Title
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Cognitive Functioning Subscale
Description
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.
Time Frame
Baseline and Day 29
Title
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Global Health/QoL Subscale
Description
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.
Time Frame
Baseline and Day 29
Title
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Role Functioning Subscale
Description
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.
Time Frame
Baseline and Day 29
Title
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Emotional Functioning Subscale
Description
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.
Time Frame
Baseline and Day 29
Title
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Social Functioning Subscale
Description
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.
Time Frame
Baseline and Day 29
Title
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Pain Subscale
Description
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
Symptom scale/item higher score represents a high level of symptomatic problem.
Time Frame
Baseline and Day 29
Title
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Nausea/Vomiting Subscale
Description
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
Symptom scale/item higher score represents a high level of symptomatic problem.
Time Frame
Baseline and Day 29
Title
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Constipation Subscale
Description
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
Symptom scale/item higher score represents a high level of symptomatic problem.
Time Frame
Baseline and Day 29
Title
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Diarrhea Subscale
Description
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
Symptom scale/item higher score represents a high level of symptomatic problem.
Time Frame
Baseline and Day 29
Title
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Insomnia Subscale
Description
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
Symptom scale/item higher score represents a high level of symptomatic problem.
Time Frame
Baseline and Day 29
Title
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Dyspnea Subscale
Description
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
Symptom scale/item higher score represents a high level of symptomatic problem.
Time Frame
Baseline and Day 29
Title
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Appetite Loss Subscale
Description
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
Symptom scale/item higher score represents a high level of symptomatic problem.
Time Frame
Baseline and Day 29
Title
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Financial Difficulties Subscale
Description
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.
Time Frame
Baseline and Day 29
Title
Health-Related Quality of Life (HRQoL) Assessed by the FACT-Lym Subscale
Description
The Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) consists of the FACT-General scale and a 15-item lymphoma-specific additional concerns subscale (LYM). This scale addresses symptoms and functional limitations that are important to lymphoma patients. The LYM items are scored on a 0 ("Not at all") to 4 ("Very much") response scale. Items are aggregated to a single score on a 0-60 scale.
Time Frame
Baseline and Day 29
Title
Health-Related Quality of Life (HRQoL) Assessed by the EuroQol Instrument EQ-5D-5L
Description
The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. These health states are converted to a single index value using the crosswalk method to the EQ-5D-3L value set from the United Kingdom (UK). The EQ-5D-5L health states ranged from -.594 for the worst (55555) to 1 for the best (11111) for UK value set with an optimal health state is assigned a score of 1.00, death is assigned a score of 0.00 and negative values representing values as worse than dead. A change of .08 is considered to be a clinically meaningful change in health utility.
Time Frame
Baseline and Day 29
Title
Numbers of Intensive Care Unit (ICU) Inpatient Days
Description
The numbers of ICU inpatient days.
Time Frame
From first dose after JCAR017 infusion to up to approximately 24 months
Title
Numbers of Non-intensive Care Unit (ICU) Inpatient Days
Description
Number of non-ICU inpatient days.
Time Frame
From first dose after JCAR017 infusion to up to approximately 24 months
Title
The Number of Participants That Were Hospitalized For Adverse Events, Prophylaxis, Other
Description
Length of hospitalization stay was reported for up to 24 months post liso-cel infusion. Reasons for hospitalization include adverse events, prophylaxis, and other. Adverse events were reported for up to 90 days post liso-cel infusion.
Time Frame
From first dose after JCAR017 infusion to up to approximately 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmation of relapsed or refractory aggressive B-cell non-Hodgkin lymphoma of the following histology at relapse: diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS; de novo or transformed follicular lymphoma [tFL]), high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double/triple hit lymphoma [DHL/THL]), and follicular lymphoma Grade 3B per WHO 2016 classification
Previous treatment must include treatment with a single line of chemoimmunotherapy containing an anthracycline and a CD20-targeted agent
Subjects must be deemed ineligible for both high-dose chemotherapy and hematopoietic stem cell transplant (based on age, performance status and/or comorbidities) while also having adequate organ function for CAR T cell treatment.
Positron emission tomography (PET)-positive disease
Histological confirmation of diagnosis at last relapse. Enough tumor material must be available for central confirmation of diagnosis, otherwise a new tumor biopsy is mandated.
ECOG performance status of 0, or 1, or 2
Adequate vascular access for leukapheresis procedure (either peripheral line or surgically-placed line)
Subjects must agree to use appropriate contraception
Subjects must agree to not donate blood, organs, semen, and egg cells for usage in other individuals for at least 1 year following lymphodepleting chemotherapy
Exclusion Criteria:
Subjects with central nervous system (CNS)-only involvement by malignancy (note: subjects with secondary CNS involvement are allowed on study)
History of another primary malignancy that has not been in remission for at least 2 years.
Previous treatment with CD19-targeted therapy, with the exception of prior lisocabtagene maraleucel treatment in this protocol for subjects receiving retreatment
Active hepatitis B or hepatitis C infection at the time of screening
History of or active human immunodeficiency virus (HIV) infection at the time of screening
Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of leukapheresis or lisocabtagene maraleucel administration
History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association, cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease
History or presence of clinically relevant CNS pathology
Pregnant or nursing women
Subject does not meet protocol-specified washout periods for prior treatments
Prior hematopoietic stem cell transplant
Progressive vascular tumor invasion, thrombosis, or embolism
Venous thrombosis or embolism not managed on stable regimen of anticoagulation
Uncontrolled medical, psychological, familial, sociological, or geographical conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Scripps Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
UNC School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Sutter Hematology and Oncology
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Sutter Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Stanford Cancer Genetics Clinic
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
The Blood and Marrow Transplant Group of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
UNC School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Kentucky/Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Norton Cancer Institute - Brownsboro
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
UNC School of Medicine
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Johns Hopkins Oncology Center Bunting Blaustein Building
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Regional Cancer Care Associates
City
East Brunswick
State/Province
New Jersey
ZIP/Postal Code
08816
Country
United States
Facility Name
UNC School of Medicine
City
East Brunswick
State/Province
New Jersey
ZIP/Postal Code
08816
Country
United States
Facility Name
New York Oncology Hematology - Albany Cancer Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
New York Oncology Hematology P.C.
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
University of Rochester Cancer Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Oncology Hematology Care, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Oncology Hematology Care
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Local Institution - 0051
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Providence Cancer Center/Earle A. Chiles Res. Inst.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
University of Pittsburgh Medical Center Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Greenville Health System - Cancer Institute - Faris Road
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Greenville Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Local Institution - 0083
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-7208
Country
United States
Facility Name
UNC School of Medicine
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Intermountain Healthcare - LDS Hospital Blood and Marrow Transplant
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
Intermountain Healthcare - LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
Northwest Medical Specialties
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
UNC School of Medicine
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Medical College of Wisconsin, Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
UNC School of Medicine
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35839786
Citation
Sehgal A, Hoda D, Riedell PA, Ghosh N, Hamadani M, Hildebrandt GC, Godwin JE, Reagan PM, Wagner-Johnston N, Essell J, Nath R, Solomon SR, Champion R, Licitra E, Fanning S, Gupta N, Dubowy R, D'Andrea A, Wang L, Ogasawara K, Thorpe J, Gordon LI. Lisocabtagene maraleucel as second-line therapy in adults with relapsed or refractory large B-cell lymphoma who were not intended for haematopoietic stem cell transplantation (PILOT): an open-label, phase 2 study. Lancet Oncol. 2022 Aug;23(8):1066-1077. doi: 10.1016/S1470-2045(22)00339-4. Epub 2022 Jul 12.
Results Reference
derived
PubMed Identifier
34515338
Citation
Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting
Learn more about this trial
Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006)
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