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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03483103
Recruitment Status : Completed
First Posted : March 30, 2018
Results First Posted : December 29, 2022
Last Update Posted : January 13, 2023
Sponsor:
Information provided by (Responsible Party):
Juno Therapeutics, a Subsidiary of Celgene

Tracking Information
First Submitted Date  ICMJE March 23, 2018
First Posted Date  ICMJE March 30, 2018
Results First Submitted Date  ICMJE September 23, 2022
Results First Posted Date  ICMJE December 29, 2022
Last Update Posted Date January 13, 2023
Actual Study Start Date  ICMJE July 26, 2018
Actual Primary Completion Date September 24, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2022)
Overall Response Rate (ORR) [ 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) ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 23, 2018)
Antitumor activity [ Time Frame: Through Month 24 ]
Overall response rate (complete response + partial response) based on "Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification"
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2022)
  • Number of Participants With Any Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From first dose to 90 days following first dose (up to approximately 90 days) ]
    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 [ Time Frame: Baseline and Day 29 ]
    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 [ Time Frame: Baseline and Day 29 ]
    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 [ Time Frame: Baseline and Day 29 ]
    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 [ Time Frame: Baseline and Day 29 ]
    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 [ Time Frame: Baseline and Day 29 ]
    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 [ Time Frame: Baseline and Day 29 ]
    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 [ 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) ]
    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) [ Time Frame: From first dose to up to approximately 24 months ]
    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) [ Time Frame: From first dose to up to approximately 24 months ]
    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) [ Time Frame: From first dose to progressive disease (PD) or death (up to approximately 24 months) ]
    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) [ Time Frame: From first dose to death from any cause, progressive disease (PD), or starting a new anticancer therapy (up to approximately 24 months) ]
    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) [ Time Frame: From first dose to date of death (up to approximately 24 months) ]
    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 [ Time Frame: From first dose to up to 24 months ]
    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 [ Time Frame: From first dose to up to 24 months ]
    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) [ Time Frame: From first dose to up to 24 months ]
    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 [ Time Frame: Baseline and Day 29 ]
    • 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 [ Time Frame: Baseline and Day 29 ]
    • 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 [ Time Frame: Baseline and Day 29 ]
    • 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 [ Time Frame: Baseline and Day 29 ]
    • 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 [ Time Frame: Baseline and Day 29 ]
    • 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 [ Time Frame: Baseline and Day 29 ]
    • 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 [ Time Frame: Baseline and Day 29 ]
    • 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 [ Time Frame: Baseline and Day 29 ]
    • 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 [ Time Frame: Baseline and Day 29 ]
    • 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 [ Time Frame: Baseline and Day 29 ]
    • 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 [ Time Frame: Baseline and Day 29 ]
    • 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 [ Time Frame: Baseline and Day 29 ]
    • 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 [ Time Frame: Baseline and Day 29 ]
    • 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 [ Time Frame: Baseline and Day 29 ]
    • 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 [ Time Frame: Baseline and Day 29 ]
    • 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 [ Time Frame: Baseline and Day 29 ]
    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 [ Time Frame: Baseline and Day 29 ]
    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 [ Time Frame: From first dose after JCAR017 infusion to up to approximately 24 months ]
    The numbers of ICU inpatient days.
  • Numbers of Non-intensive Care Unit (ICU) Inpatient Days [ Time Frame: From first dose after JCAR017 infusion to up to approximately 24 months ]
    Number of non-ICU inpatient days.
  • The Number of Participants That Were Hospitalized For Adverse Events, Prophylaxis, Other [ Time Frame: From first dose after JCAR017 infusion to up to approximately 24 months ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2018)
  • Adverse events [ Time Frame: 90 days ]
    Proportion of subjects experiencing adverse events
  • Laboratory abnormalities [ Time Frame: 90 days ]
    Proportion of subjects experiencing laboratory abnormalities
  • Antitumor activity [ Time Frame: Through Month 24 ]
    Complete response rate based on "Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification"
  • Antitumor activity [ Time Frame: Through Month 24 ]
    Duration of response
  • Pharmacokinetics [ Time Frame: Through Month 24 ]
    Maximum concentration of lisocabtagene maraleucel in blood
  • Pharmacokinetics [ Time Frame: Through Month 24 ]
    Time of the maximum concentration of lisocabtagene maraleucel in blood
  • Pharmacokinetics [ Time Frame: Through Month 24 ]
    Area under the curve of lisocabtagene maraleucel in blood
  • Progression-free survival [ Time Frame: Through Month 24 ]
    Progression-free survival
  • Overall survival [ Time Frame: Through Month 24 ]
    Overall survival
  • Health-related quality of life and health economics and outcomes research [ Time Frame: Through Month 24 ]
    EORTC QLQ-C30
  • Health-related quality of life and health economics and outcomes research [ Time Frame: Through Month 24 ]
    EuroQol instrument EQ-5D-5L
  • Health-related quality of life and health economics and outcomes research [ Time Frame: Through Month 24 ]
    Numbers of intensive care unit inpatient days and non-ICU inpatient days and reasons for hospitalization
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006)
Official Title  ICMJE A Phase 2 Study of Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy in Adult Patients With Aggressive B-cell NHL (017006)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Nonhodgkin
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse
Intervention  ICMJE Biological: lisocabtagene maraleucel
lisocabtagene maraleucel will be administered as a single dose intravenous (IV) injection
Other Names:
  • JCAR017
  • liso-cel
Study Arms  ICMJE Experimental: Treatment
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: Biological: lisocabtagene maraleucel
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 23, 2022)
74
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2018)
56
Actual Study Completion Date  ICMJE December 1, 2022
Actual Primary Completion Date September 24, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03483103
Other Study ID Numbers  ICMJE 017006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Juno Therapeutics, a Subsidiary of Celgene
Original Responsible Party Juno Therapeutics, Inc.
Current Study Sponsor  ICMJE Juno Therapeutics, a Subsidiary of Celgene
Original Study Sponsor  ICMJE Juno Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Juno Therapeutics, a Subsidiary of Celgene
Verification Date January 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP