A Study to Evaluate the Efficacy and Safety of Liso-cel Compared to Standard of Care in Adults With Relapsed or Refractory Follicular Lymphoma
brief summary
The purpose of this study is to evaluate the efficacy and safety of Liso-cel compared to standard of care in adults with Relapsed or Refractory Follicular Lymphoma.
detailed description
The purpose of this phase III study is to evaluate the clinical benefit of liso-cel for the treatment of r/r FL by comparing it to standard of care therapy in patients with r/r FL, with progression-free survival (PFS) as the primary endpoint.
The primary objective is to demonstrate superiority of the Liso-cel treatment strategy over standard of care (SOC) therapy with respect to progression-free survival (PFS) determined by independent review committee (IRC) based on the Lugano response criteria.
Participants randomized to Arm A (Standard of Care) will receive RCHOP, BR, or R2 based on investigator choice and this has to be determined prior to randomization.
Participants randomized to Arm B (Liso-cel treatment) will receive a single infusion CAR-positive viable T-cells.
official title
A Global Randomized Multicenter Phase 3 Trial to Compare the Efficacy and Safety of Lisocabtagene Maraleucel (JCAR017/BMS-986387) to Standard of Care in Adults With Relapsed or Refractory Follicular Lymphoma (TRANSFORM FL)