Axicabtagene Ciloleucel for Non-Hodgkin's Lymphoma
(ZUMA-5 Trial)
Trial Summary
What is the purpose of this trial?
This study will enroll approximately 160 adult participants who have relapsed or refractory (r/r) iNHL to be infused with the study treatment, axicabtagene ciloleucel, to see if their disease responds to this experimental product and if this product is safe. Axicabtagene ciloleucel is made from the participants own white blood cells which are genetically modified and grown to fight cancer. An objective response rate of 70% is targeted.
Research Team
Kite Study Director
Principal Investigator
Kite, A Gilead Company
Eligibility Criteria
Adults with relapsed or refractory indolent Non-Hodgkin Lymphoma, specifically follicular lymphoma or marginal zone lymphoma that worsened after at least two prior treatments. Participants must have measurable disease, no CNS lymphoma involvement, and be able to stop current therapies before leukapheresis. They should be in good physical condition (ECOG 0-1) and not pregnant or breastfeeding.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Leukapheresis
Participants undergo leukapheresis to collect white blood cells for manufacturing
Conditioning Chemotherapy
Participants receive conditioning chemotherapy with cyclophosphamide and fludarabine for 3 days
Treatment
Participants are infused with axicabtagene ciloleucel and monitored in a hospital for a minimum of 7 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants transition to a long-term follow-up study for the remainder of the 15-year follow-up assessments
Treatment Details
Interventions
- Axicabtagene Ciloleucel
- Cyclophosphamide
- Fludarabine
Axicabtagene Ciloleucel is already approved in United States, European Union for the following indications:
- Large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy
- Relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy
- Relapsed or refractory follicular lymphoma after two or more lines of systemic therapy
- Diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy
- Relapsed or refractory DLBCL and primary mediastinal large B-cell lymphoma, after two or more lines of systemic therapy
- Relapsed or refractory follicular lymphoma after three or more lines of systemic therapy
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Who Is Running the Clinical Trial?
Kite, A Gilead Company
Lead Sponsor