CA082-011 Liso-cel Compared to Standard of Care in Adults with Follicular Lymphoma
Research type
Research Study
Full 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)
IRAS ID
1009545
Contact name
GSM-CT Representative
Contact email
Sponsor organisation
Celgene Corporation
Research summary
There has been some progress when trying to treat relapsed/refractory follicular lymphoma (R/R FL), however, there is still a huge need for treatments that can create lasting responses.
Phase 3 studies compare new treatments with currently available treatments. The purpose of this study is to see if Liso-cel is safer and more effective than existing standard of care treatments for people with R/R FL.
Liso-cel is made from the participant’s own T-cells, a type of white blood cell that helps fight infection. The participant’s T-cells are modified in a lab (genetically engineered) to make CAR T-cells. These CAR T-cell can recognise and attack cancer cells. Manufacturing CAR T-cell therapy is a hard and complex process which involves lots of steps and can take several weeks.
There are around 300 participants with R/R FL that will be taking part in this study. Each participant will be randomized in a 1:1 ratio to one of the two following Arms:
• Arm A (SOC): the SOC therapy will be one of three currently available treatment regimens selected by the study doctor.
• Arm B (liso-cel treatment ): this will include bridging therapy (these are treatments aimed to slow the disease while liso-cel is being manufactured and will only be used if needed). This will be followed by lymphodepleting chemotherapy, which is a short course of chemotherapy to kill the current T-cells to replace them with the specialised liso-cel CAR-T cells. Liso-cel will be given as an intravenous infusion.The study is divided into a Screening Period, a Treatment Period, and a Post-treatment Follow-up Period. The expected total study duration is approximately 8 years, including an enrolment period of approximately 31 months. All participants who receive liso-cel, after finishing the study, will continue to be monitored for long-term survival under a separate long-term follow-up (LTFU) protocol for up to 15 years after study drug infusion.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
24/LO/0221
Date of REC Opinion
18 Apr 2024
REC opinion
Further Information Unfavourable Opinion