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A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma
Gilead Sciences, Inc.
Eligible patients with relapsed/refractory Diffuse Large B-Cell Lymphoma (DLBCL) after first-line rituximab and anthracycline-based chemotherapy, will be randomised 1:1 to receive the investigational therapy (axicabtagene ciloleucel) or standard of care chemotherapy. Patients that are randomised to receive axicabtagene ciloleucel will have a singe intravenous infusion of chimeric antigen receptor (CAR)-transduced autologous T cells, following conditioning chemotherapy. Patients randomised to receive standard of care chemotherapy will be given one of the following regimens - R-ICE, R-DHAP, R-ESHAP, or R-GDP - as selected by the investigator. Standard of care chemotherapy will be followed by high dose therapy (eg, BEAM) and an autologous stem cell transplant for responders.