An Adaptive Phase 3, Randomized, Open-Label,Multicenter Study to Compare the Efficacy and Safety ofAxicabtagene Ciloleucel versus Standard of Care Therapy asFirst-Line Therapy in Subjects with High-Risk Large B-CellLymphoma (ZUMA-23)
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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).
Are you Eligible? (Inclusion Criteria)
- Are you 18 years or older? - Have you received only 1 cycle of R-chemotherapy? - Do you have High-Risk Large B-Cell Lymphoma?
