(Funded by Kite Pharma and the Leukemia and Lymphoma Society Therapy Acceleration Program ZUMA-1 number, NCT02348216.) Introduction In this multicenter study, patients with refractory large B-cell lymphoma who received CAR T-cell therapy with axi-cel had high levels of durable response, with a safety profile that included myelosuppression, the cytokine release syndrome, and neurologic events. Higher CAR T-cell levels in blood were associated with response. Three of the patients died during treatment. Grade 3 or higher cytokine release syndrome and neurologic events occurred in 13% and 28% of the patients, respectively. The most common adverse events of grade 3 or higher during treatment were neutropenia (in 78% of the patients), anemia (in 43%), and thrombocytopenia (in 38%). The overall rate of survival at 18 months was 52%. The objective response rate was 82%, and the complete response rate was 54%.With a median follow-up of 15.4 months, 42% of the patients continued to have a response, with 40% continuing to have a complete response. ResultsĪmong the 111 patients who were enrolled, axi-cel was successfully manufactured for 110 (99%) and administered to 101 (91%). Secondary end points included overall survival, safety, and biomarker assessments. The primary end point was the rate of objective response (calculated as the combined rates of complete response and partial response). Patients received a target dose of 2×10 6 anti-CD19 CAR T cells per kilogram of body weight after receiving a conditioning regimen of low-dose cyclophosphamide and fludarabine. In this multicenter, phase 2 trial, we enrolled 111 patients with diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, or transformed follicular lymphoma who had refractory disease despite undergoing recommended prior therapy. In a phase 1 trial, axicabtagene ciloleucel (axi-cel), an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, showed efficacy in patients with refractory large B-cell lymphoma after the failure of conventional therapy. Original Article Axicabtagene Ciloleucel CAR T-Cell Therapy in Refractory Large B-Cell Lymphoma List of authors. The most trusted, influential source of new medical knowledge and clinical best practices in the world.
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