A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas (TRANSFORM)
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|ClinicalTrials.gov Identifier: NCT03575351|
Recruitment Status : Recruiting
First Posted : July 2, 2018
Last Update Posted : December 27, 2018
The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.
This is a randomized, open-label, parallel-group, multi-center trial in adult subjects with Relapsed or refractory (R/R) aggressive Non-Hodgkin lymphoma (NHL) to compare safety and efficacy between the standard of care (SOC) strategy versus JCAR017 (also known as lisocabtagene maraleucel or liso-cel). Subjects will be randomized to either receive SOC (Arm A) or to receive JCAR017 (Arm B).
All subjects randomized to Arm A will receive Standard of care (SOC) salvage therapy (R-DHAP, RICE or R-GDP) as per physician's choice before proceeding to High dose chemotherapy (HDCT) and Hematopoietic stem cell transplant (HSCT).
Subjects from Arm A may be allowed to cross over and receive JCAR017 upon confirmation of an EFS event.
Subjects randomized to Arm B will receive Lymphodepleting (LD) chemotherapy followed by JCAR017 infusion.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, Non-Hodgkin||Drug: Standard of Care Genetic: JCAR017||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||182 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Global Randomized Multicenter Phase 3 Trial of JCAR017 Compared to Standard of Care in Adult Subjects With High-risk, Second-line, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas (TRANSFORM).|
|Actual Study Start Date :||October 23, 2018|
|Estimated Primary Completion Date :||October 14, 2022|
|Estimated Study Completion Date :||January 13, 2023|
Active Comparator: Arm A - Standard of Care (SOC)
Subjects should receive SOC (R-DHAP, R-ICE or R-GDP) followed by HDCT (BEAM) and HSCT. Standard of care regimen will be administered as per investigator decision.
Drug: Standard of Care
Standard of Care
Experimental: Arm B - JCAR017
Lymphodepleting chemotherapy with intravenous (IV) fludarabine (30 mg/m2/day for 3 days) plus cyclophosphamide IV (300 mg/m2/day for 3 days) (flu/cy) concurrently followed by JCAR017 infusion.
Other Name: lisocabtagene maraleucel or liso-cel
- Event-free survival (EFS) [ Time Frame: Approximately 3 years ]Time from randomization to death from any cause, progressive disease (PD), as assessed by the independent review committee (IRC) or start of new antineoplastic therapy, whichever occurs first
- Complete response rate (CRR) [ Time Frame: Approximately 3 years ]Percentage of subjects achieving a complete response (CR) according to the Lugano Classification assessed by the IRC
- Progression-free survival (PFS) [ Time Frame: Approximately 3 years ]Time from randomization to PD, SD at 1st response assessment as per protocol schedule, as per IRC review or death from any cause, whichever occurs first
- Overall survival (OS) [ Time Frame: Approximately 4.5 years ]Time from randomization to time of death due to any cause
- Overall response rate (ORR) [ Time Frame: Approximately 3 years ]Percentage of subjects achieving an objective response of partial response (PR) or better according to the Lugano Classification as assessed by IRC review
- Duration of response (DOR) [ Time Frame: Approximately 3 years ]Time from first response to disease progression, start of new antineoplastic therapy or death from any cause
- PFS on next line of treatment (PFS-2) [ Time Frame: Approximately 3 years ]Time from randomization to second objective disease progression or death from any cause, whichever is first.
- Adverse Events (AEs) [ Time Frame: Approximately 3 years ]Type, frequency and severity of adverse events (AEs), serious adverse events (SAE), and laboratory abnormalities (overall and in clinical, histological and molecular subgroups)
- HRQoL parameters assessed by European Organisation for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC-QLQ-C30) [ Time Frame: Approximately 3 years ]European Organisation for Research and Treatment of Cancer - Quality of Life C30 questionnaire: The EORTC QLQ-C30 questionnaire will be used as a measure of health-related quality of life.
- HRQoL parameters assessed by EQ-5D-5L [ Time Frame: Approximately 3 years ]European Quality of Life-5 Dimensions health state classifier to 5 Levels questionnaire: EQ-5D is a standardized measure of health status developed by the EuroQol Group to provide a simple, generic measure of health for clinical and economic appraisal.
- HRQoL parameters assessed by FACT-Lym "Additional concerns" subscale [ Time Frame: Approximately 3 years ]Functional Assessment of Cancer Therapy-Lymphoma "Additional concerns" subscale: Only the LYM subscale will be administered in this study. This scale addresses symptoms and functional limitations (15 item) that are important to lymphoma patients.
- Reasons for hospital resource utilization [ Time Frame: Approximately 3 years ]Will be assessed based on reasons for hospitalization
- Rate of hematopoietic stem cell transplant (HSCT) [ Time Frame: Approximately 3 years ]Rate of completion of HDCT and HSCT
- Frequency of hospital resource utilization [ Time Frame: Approximately 3 years ]Will be assessed based on frequency of hospitalizations calculated as, inpatient days, intensive care unit (ICU) days, outpatient visits days
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03575351
|Contact: Associate Director Clinical Trial Disclosureemail@example.com|
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|Study Director:||Alessandro Crotta, MD||Celgene|