ZUMA-22
Research type
Research Study
Full title
A Phase 3 Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects with Relapsed/Refractory Follicular Lymphoma
IRAS ID
1005321
Contact name
Sarah Enever
Contact email
Sponsor organisation
Kite Pharma, Inc.
Eudract number
2021-003260-28
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to determine if the experimental IMP, axicel is safe effective for people diagnosed with relapsed/refractory follicular lymphoma compared to standard of care therapy (SOC) which may include Rituximab/Bendamustine (BR),Rituximab/Cyclophosphamide/Doxorubicin/Vincristine/Prednisone (R-CHOP) or Rituximab/Lenalidomide (R2). Production of experimental treatment involves collecting white blood cells (T cells) from the participant and genetically modifying those cells to target and kill cancer cells. Additional therapy (corticosteroid) may be administered while participants wait for those cells to be released. The genetically modified T cells are then infused into the participant, assessing the effect on the cancer cells. If a participant meets the eligibility criteria and are assigned randomly to the experimental treatment group, they will undergo a procedure called leukapheresis. Following the one course of axicel infusion, in the observation period, participants will return 3 months until 1 year and every 4 months for another year to monitor their health and if the disease is responding to the axicel IMP. Following the post IMP assessment period, participants will return every 6 months until 5 years. Because studies involving genetically engineered cells require long-term follow-up, participants may need to be followed in the study for 15 years if they are in the experimental treatment group, starting in this study and later transferring to a Long Term Follow Up (LTFU) study. If a participants is randomly assigned to the SOC group, they will receive 6-12 cycles of a chemotherapy, starting 7 days after the date participants are randomised. Each cycle of SOC will be 3-4 weeks apart. Following post treatment assessment period of the SOC group, participants will return every 6 months until 5 years. This study is organised, funded by the Sponsor Kite Pharma, Inc, & planned to be carried out in US, Europe. A total of 230 patients will be enrolled.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
22/LO/0405
Date of REC Opinion
5 Aug 2022
REC opinion
Further Information Favourable Opinion