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Prophylactic Corticosteroid Use In Patients Receiving Axicabtagene Ciloleucel For Large B-Cell Lymphoma, Olalekan O. Oluwole, Krimo Bouabdallah, Javier Muñoz, Sophie De Guibert, Julie M. Vose, Nancy L. Bartlett, Yi Lin, Abhinav Deol, Peter A. Mcsweeney, Andre H. Goy, Marie José Kersten, Caron A. Jacobson, Umar Farooq, Monique C. Minnema, Catherine Thieblemont, John M. Timmerman, Patrick Stiff, Irit Avivi, Dimitrios Tzachanis, Jenny J. Kim, Zahid Bashir, Jeff Mcleroy, Yan Zheng, John M. Rossi, Lisa Johnson, Lovely Goyal, Tom Van Meerten

Journal Articles: Internal Medicine

ZUMA-1 (NCT02348216) examined the safety and efficacy of axicabtagene ciloleucel (axi-cel), an autologous CD19-directed chimaeric antigen receptor (CAR)-T cell therapy, in refractory large B-cell lymphoma. To reduce treatment-related toxicity, several exploratory safety management cohorts were added to ZUMA-1. Specifically, cohort 6 investigated management of cytokine release syndrome (CRS) and neurologic events (NEs) with prophylactic corticosteroids and earlier corticosteroid and tocilizumab intervention. CRS and NE incidence and severity were primary end-points. Following leukapheresis, patients could receive optional bridging therapy per investigator discretion. All patients received conditioning chemotherapy (days -5 through -3), 2 × 10⁶ CAR-T cells/kg (day 0) …