A global randomized multicenter Phase 3 trial 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)
Categories (click each to see list of all clinical trials associated with that category): Lymphoma/Chronic lymphocytic leukemia (CLL)
Current Status: Open to accrual
Phase: III
Principal Investigator: Lunning, Matthew
Eligibility: https://clinicaltrials.gov/ct2/show/NCT03575351#eligibility
Summary
Primary Objective:
To compare the efficacy in subjects treated with JCAR017 versus subjects treated according to
standard of care (SOC) defined as event-free survival (EFS)
Key Secondary Objectives:
To compare additional parameters of efficacy in subjects treated with JCAR017 versus subjects
treated according to SOC defined as complete response rate (CRR), progression-free survival
(PFS), and overall survival (OS)
Secondary Objectives:
To compare other parameters of efficacy, defined as duration of response (DOR), overall
response rate (ORR), and PFS on next line of treatment (PFS-2)
To compare efficacy rates (EFS, PFS, OS) at 6, 12 and 24 months after randomization
To compare safety defined as type and frequency of adverse events (AEs), serious
adverse events (SAEs), and laboratory abnormalities
To compare the safety and efficacy in clinical, histological and molecular subgroups
To compare health-related quality of life (HRQoL)
To compare hospital resource utilization (HRU)
To describe the rate of completion of high dose chemotherapy (HDCT) and
hematopoietic stem cell transplant (HSCT)
To assess the response 3 months after HSCT