Results
aggressive B cell non-Hodgkin lymphoma
ADVERSE EVENTS, SECONDARY
The primary end point was investigator-assessed complete metabolic response (CMR) at 3 months from the axi-cel infusion. Secondary end points were objective response rate (ORR) at 3 months from the axi-cel infusion, CMR at 6 months from the axi-cel infusion, best ORR, best CMR, duration of response (DOR), EFS from leukapheresis, PFS from infusion, OS from infusion and the incidence, nature and severity of adverse events. Additional planned secondary end points not reported in this manuscript include health-related quality of life and the cell product characteristics and cellular kinetics of axi-cel.In the initial study protocol, we calculated that a sample size of 40 patients with aggressive B cell non-Hodgkin lymphoma that was refractory to or had relapsed no more than 12 months after first-line chemoimmunotherapy and who were ineligible for HDCT/ASCT based on a physician’s assessment was sufficient to test the efficacy of axi-cel infusion. Our initial part of the study (