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)
Sponsor: |
Kite Pharma Inc |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAU4058 |
U.S. Govt. ID: |
NCT05605899 |
Contact: |
Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu |
The purpose of this study is to find out if the experimental product, axi-cel, is safe and effective in treating your lymphoma, compared to standard of care (SOC) therapy (chemotherapy), which includes either R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone) or DA EPOCH R (dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab). The experimental treatment would involve removing some of your immune cells, genetically engineering those cells to identify cancer, receiving additional therapy while you wait for those cells to be manufactured, and then infusing those cells back and assessing the effect on your cancer. The experimental product, axi-cel, is not approved by the US Food and Drug Administration (FDA). Participants in both treatment arms will be followed for up to approximately 5 years after being randomized into a study treatment group (randomly assigned, like the flip of a coin).
Investigator
Ran Reshef, MD
Are you at least 18 years old? |
Yes |
No |
Have you been diagnosed with High-Risk Large B-Cell Lymphoma? |
Yes |
No |