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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)
This is a randomized, open-label, parallel-group, multi-center trial in adult patients 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). Patients will be randomized to either receive SOC (Arm A) or to receive JCAR017 (Arm B).
The primary of objective of the study is to compare the efficacy in subjects treated with JCAR017 versus subjects treated according to standard of care (SOC) defined as event-free survival (EFS). The key secondary objectives are to compare the 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). The secondary objectives are: -to compare other parameters of efficacy, defined as duration of response (DOR), overall response rate (ORR), PFS on next line of treatment (PFS-2) -to compare efficacy rates (EFS, PFS, OS) at 6, 12, 24, and 36 months after randomization -to compare the 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 The exploratory objectives are: -to assess the effect of JCAR017 attributes on safety, pharmacokinetics (PK), and antitumor activity -to evaluate the immune responses directed against JCAR017 -to evaluate the role of tumor and the tumor microenvironment in mechanisms of response and resistance to JCAR017 -to evaluate the tumor and the tumor microenvironment in subjects treated according to SOC for correlates of efficacy within the SOC arm and for subjects who cross over to JCAR017 -to describe the effect of treatments directed at severe cytokine release syndrome (sCRS) and neurotoxicity and duration and severity of these events and whether these safety features are affected by initial SOC treatment for subjects that cross over to JCAR017 -to assess the safety and efficacy for subjects who crossed over to JCAR017
JCAR017 (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)
> Between 18 years 75 years of age at the time of signing the informed consent form (ICF).
> Participants not eligible for hematopoietic stem cell transplantation (HSCT).