CA082-1170 - CLL PMR LisoCel vs Investigator Choice
Research type
Research Study
Full title
A Global Phase 3, Randomized, Open-label, Multi-center Trial Designed to Compare the Efficacy and Safety of Lisocabtagene Maraleucel vs Investigator’s Choice Options (idelalisib + rituximab or bendamustine + rituximab) in Adult Participants with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), Whose Disease Has Failed Treatment with Both BTKi and BCL2i Targeted Therapies (A Double Class Exposed Population) Exposed Population)
IRAS ID
1009227
Contact name
GSM-CT Representative
Contact email
Sponsor organisation
Celgene Corporation (a subsidiary of Bristol Myers Squibb Company)
Eudract number
2023-506273-36
Research summary
Chronic Lymphocytic Leukaemia (CLL) or small lymphocytic lymphoma (SLL) remains incurable for many people despite recent advances in treatments. New treatments are urgently needed for people with this disease. Phase 3 studies compare new treatments with currently available treatments. This is a study of the investigational drug Lisocabtagene Maraleucel (Liso-cel) in adults with CLL or SLL, whose disease has returned or whose disease has not responded to previous treatment. The study will compare Liso-cel (Arm A) with the current treatments (investigators choice) of Rituximab and Idelalisib or Rituximab and Bendamustine (Arm B). Participants are randomised to receive either the study drug (Arm A) or the investigators choice (Arm B). Participants and their hospital doctor will know which treatment they are on. For people randomised to Arm B, investigators choice, their doctor will decide whether Rituximab and Idelalisib or Rituximab and Bendamustine is the best treatment for them. 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 complex and specialised process which involves a number of steps and can take several weeks. Liso-cel is administered as an intravenous infusion. Approximately 200 adults will take part in the study world-wide with 14 taking part in the UK. Participants on Arm A will receive Liso-cel whilst participants on Arm B will receive one of the investigator’s choice of treatment regimen. There is the possibility of participants on Arm B to receive liso-cel in the future, if their CLL/SLL comes back.
After completion of the treatment period (2 years), participants will be followed up in the post-treatment phase every 6 months for 5 years.REC name
London - West London & GTAC Research Ethics Committee
REC reference
24/LO/0075
Date of REC Opinion
21 Mar 2024
REC opinion
Further Information Unfavourable Opinion