ZUMA-7
Research type
Research Study
Full title
A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel versus Standard of Care Therapy in Subjects with Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA -7)
IRAS ID
230779
Contact name
Katherine Cwynarski
Contact email
Sponsor organisation
Kite Pharma, Inc.
Eudract number
2017-002261-22
Clinicaltrials.gov Identifier
016278, IND
Duration of Study in the UK
16 years, 9 months, 17 days
Research summary
Non-Hodgkin lymphoma (NHL) is the most common blood cancer accounting for 4% of all new cancers. Diffuse large B-cell lymphoma (DLBCL) is the most common sub-type of NHL. For these cancer patients, when their cancer has come back or not improved within 1 year of rituximab-based chemoimmunotherapy, their prognosis is poor. Research has shown that immunotherapy, which is based on the patients’ immune system responding against the cancer, is a promising approach to treating many types of cancer.
This study involves removing some of the participants’ immune cells, genetically engineering those cells to identify cancer (turning them into the study medication axicabtagene ciloleucel, also called axi-cel) and then putting axi-cel back into the participants’ bodies and studying if this experimental therapy is safe and effective in treating DLBCL, compared to the standard of care (SOC) therapy.
Approximately 350 adult participants with DLBCL which has come back quickly or not been responsive to their first chemoimmunotherapy, will take part. The participants will attend one of 60 sites across North America, Europe and Israel.
Participants will be randomly assigned in a 1:1 ratio to either receive axi-cel or SOC.
The time that the participants will be on the study will vary dependent on their treatment and their response. A participant that completes the whole study from signing the consent through treatment and follow-up, regardless of which treatment, will take approximately 15 years to complete as studies involving genetically engineered cells require long term follow up.
The participants will be required to attend visits at the study site. Visits can last from a few hours to several days depending on the treatment and stage of the treatment. During these visits the participants will undergo various procedures to administer study medication or standard of care therapy and assess disease status.REC name
London - West London & GTAC Research Ethics Committee
REC reference
17/LO/2060
Date of REC Opinion
16 Feb 2018
REC opinion
Further Information Favourable Opinion