ZUMA-23
Research type
Research Study
Full title
An Adaptive Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Axicabtagene Ciloleucel versus Standard of Care Therapy as First-Line Therapy in Subjects with High- Risk Large B-Cell Lymphoma (ZUMA-23)
IRAS ID
1006193
Contact name
Olga Nikolajeva
Contact email
Sponsor organisation
Kite Pharma, Inc.
Eudract number
2022‐501489‐24
Clinicaltrials.gov Identifier
Research summary
The purpose of the KT-US-484-0136 study, sponsored by Kite Pharma Inc, is to compare the efficacy and safety of Axicabtagene ciloleucel (Axi-cel) against Standard of Care Therapy (SoCT) as first-line therapy in participants with high-risk large B-cell lymphoma. R-CHOP remains the standard regimen for large B-cell lymphoma (LBCL), including high-risk and advanced-stage patients. However, approximately 40% of patients are refractory after R-CHOP therapy (the cancer does not respond to treatment) or relapse (the cancer returns). Axi-cel is manufactured using the participant’s own blood cells which is genetically modified to target lymphoma cells. It is currently used in patients with relapsed LBCL. In this study, we are examining if Axi-cel is more effective than standard R-CHOP chemotherapy in patients with high-risk LBCL who have not previously received therapy. This will primarily be assessed by comparing clinical outcomes (event-free survival) in patients treated with Axi-cel and those with R-CHOP. Other outcomes including survival, side-effects, and quality of life will also be assessed. Participants will be randomly assigned to receive either Axi-cel or SoCT in a 1:1 ratio. Participants allocated Axi-cel will first undergo leukapheresis (a process where white blood cells are collected from the participant’s blood), optional bridging therapy (a temporary therapy while the participant’s Axi-cel is being manufactured), and lymphodepletion chemotherapy (treatment, but to increase the efficacy of Axi-cel by modulating the participant’s immune system). The participants will then receive a single infusion of Axi-cel and remain in hospital for at least 7 days for close monitoring. Participants allocated the SoCT will receive a total of 6 cycles of treatment. All participants will be followed for approximately 5 years. Participants receiving Axi-cel will continue to be followed up for approximately 10 more years. Between 200 and 400 patients will participate in the study.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
23/LO/0041
Date of REC Opinion
4 Sep 2023
REC opinion
Further Information Favourable Opinion