Spots Global Cancer Trial Database for A Study to Evaluate the Efficacy and Safety of Liso-cel Compared to Standard of Care in Adults With Relapsed or Refractory Follicular Lymphoma

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial