Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006)

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

A Phase 2 Study of Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy in Adult Patients With Aggressive B-cell NHL (017006)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03483103
• Other study ID #: 017006
• Status: Completed
• Phase: Phase 2
• Start date: July 27, 2018
• Est. completion date: December 1, 2022

Study information

• Verified date: November 2023
• Source: Juno Therapeutics, a Subsidiary of Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: December 1, 2022
• Est. primary completion date: September 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Non-Hodgkin
• Lymphoma, Nonhodgkin

Intervention

Biological:
• lisocabtagene maraleucel
lisocabtagene maraleucel will be administered as a single dose intravenous (IV) injection

Locations

Country	Name	City	State
United States	New York Oncology Hematology - Albany Cancer Center	Albany	New York
United States	New York Oncology Hematology P.C.	Albany	New York
United States	Local Institution - 0019	Atlanta	Georgia
United States	The Blood and Marrow Transplant Group of Georgia	Atlanta	Georgia
United States	UNC School of Medicine	Atlanta	Georgia
United States	Johns Hopkins Oncology Center Bunting Blaustein Building	Baltimore	Maryland
United States	Local Institution - 0009	Baltimore	Maryland
United States	The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	Local Institution - 0021	Charlotte	North Carolina
United States	Local Institution - 0003	Chicago	Illinois
United States	Local Institution - 0016	Chicago	Illinois
United States	Northwestern University	Chicago	Illinois
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	University of Chicago Comprehensive Cancer Center	Chicago	Illinois
United States	Local Institution - 0039	Cincinnati	Ohio
United States	Oncology Hematology Care	Cincinnati	Ohio
United States	Oncology Hematology Care, Inc.	Cincinnati	Ohio
United States	Local Institution - 0083	Dallas	Texas
United States	UNC School of Medicine	Dallas	Texas
United States	Local Institution - 0052	East Brunswick	New Jersey
United States	Regional Cancer Care Associates	East Brunswick	New Jersey
United States	UNC School of Medicine	East Brunswick	New Jersey
United States	Banner MD Anderson Cancer Center	Gilbert	Arizona
United States	Local Institution - 0043	Gilbert	Arizona
United States	Greenville Health System	Greenville	South Carolina
United States	Greenville Health System - Cancer Institute - Faris Road	Greenville	South Carolina
United States	Local Institution - 0037	Greenville	South Carolina
United States	Scripps Clinic	La Jolla	California
United States	Local Institution - 0046	Lexington	Kentucky
United States	University of Kentucky	Lexington	Kentucky
United States	University of Kentucky/Markey Cancer Center	Lexington	Kentucky
United States	UNC School of Medicine	Los Angeles	California
United States	University of California Los Angeles	Los Angeles	California
United States	Local Institution - 0064	Louisville	Kentucky
United States	Norton Cancer Institute - Brownsboro	Louisville	Kentucky
United States	UNC School of Medicine	Louisville	Kentucky
United States	Local Institution - 0055	Milwaukee	Wisconsin
United States	Medical College of Wisconsin, Froedtert Hospital	Milwaukee	Wisconsin
United States	UNC School of Medicine	Milwaukee	Wisconsin
United States	Local Institution - 0029	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center Hillman Cancer Center	Pittsburgh	Pennsylvania
United States	Local Institution - 0051	Portland	Oregon
United States	Providence Cancer Center/Earle A. Chiles Res. Inst.	Portland	Oregon
United States	Providence Portland Medical Center	Portland	Oregon
United States	Local Institution - 0090	Rochester	New York
United States	University of Rochester Cancer Center	Rochester	New York
United States	University of Rochester Medical Center	Rochester	New York
United States	Sutter Hematology and Oncology	Sacramento	California
United States	Sutter Medical Center	Sacramento	California
United States	Intermountain Healthcare - LDS Hospital	Salt Lake City	Utah
United States	Intermountain Healthcare - LDS Hospital Blood and Marrow Transplant	Salt Lake City	Utah
United States	Local Institution - 0074	Salt Lake City	Utah
United States	Local Institution - 0092	Stanford	California
United States	Stanford Cancer Center	Stanford	California
United States	Stanford Cancer Genetics Clinic	Stanford	California
United States	Northwest Medical Specialties	Tacoma	Washington
United States	UNC School of Medicine	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Juno Therapeutics, a Subsidiary of Celgene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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.	From first dose to 90 days following first dose (up to approximately 90 days)
Secondary	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.	Baseline and Day 29
Secondary	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.	Baseline and Day 29
Secondary	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.	Baseline and Day 29
Secondary	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.	Baseline and Day 29
Secondary	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.	Baseline and Day 29
Secondary	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.	Baseline and Day 29
Secondary	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.	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)
Secondary	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.	From first dose to up to approximately 24 months
Secondary	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.	From first dose to up to approximately 24 months
Secondary	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.	From first dose to progressive disease (PD) or death (up to approximately 24 months)
Secondary	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.	From first dose to death from any cause, progressive disease (PD), or starting a new anticancer therapy (up to approximately 24 months)
Secondary	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.	From first dose to date of death (up to approximately 24 months)
Secondary	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.	From first dose to up to 24 months
Secondary	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.	From first dose to up to 24 months
Secondary	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.	From first dose to up to 24 months
Secondary	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.	Baseline and Day 29
Secondary	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.	Baseline and Day 29
Secondary	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.	Baseline and Day 29
Secondary	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.	Baseline and Day 29
Secondary	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.	Baseline and Day 29
Secondary	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.	Baseline and Day 29
Secondary	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.	Baseline and Day 29
Secondary	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.	Baseline and Day 29
Secondary	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.	Baseline and Day 29
Secondary	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.	Baseline and Day 29
Secondary	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.	Baseline and Day 29
Secondary	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.	Baseline and Day 29
Secondary	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.	Baseline and Day 29
Secondary	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.	Baseline and Day 29
Secondary	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.	Baseline and Day 29
Secondary	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.	Baseline and Day 29
Secondary	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.	Baseline and Day 29
Secondary	Numbers of Intensive Care Unit (ICU) Inpatient Days	The numbers of ICU inpatient days.	From first dose after JCAR017 infusion to up to approximately 24 months
Secondary	Numbers of Non-intensive Care Unit (ICU) Inpatient Days	Number of non-ICU inpatient days.	From first dose after JCAR017 infusion to up to approximately 24 months
Secondary	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.	From first dose after JCAR017 infusion to up to approximately 24 months

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting