Outcomes
lymphoma, toxicities, death, CRS
DISEASE PROGRESSION, ADVERSE EFFECTS, DISEASE, EVENT, ADVERSE EFFECTS, SECONDARY, LYMPHOMA, PMR
The primary end point was investigator-assessed CMR at 3 months from the axi-cel infusion according to the Lugano response criteriaSecondary efficacy end points included investigator-assessed ORR at 3 months from the axi-cel infusion, investigator-assessed CMR at 6 months from the axi-cel infusion and the best investigator-assessed ORR and CMR. CMR and ORR at 3 months from the axi-cel infusion were also assessed by a central review panel formed by two readers and an adjudicator. Other secondary efficacy outcomes included the best ORR and best CMR as assessed by the central review panel, DOR, EFS from leukapheresis, PFS from infusion and OS from infusion. DOR, EFS and PFS were investigator-assessed. DOR was defined as the time from attainment of PMR or CMR to the date of first documented disease progression/relapse or death from any cause. EFS was defined as the time between leukapheresis and any event preventing axi-cel infusion if axi-cel was never infused, or death, disease progression or instauration of a new lymphoma therapy for lymphoma progression after axi-cel infusion. PFS was defined as the time from axi-cel infusion to disease progression or death from any cause. OS was defined as the time from axi-cel infusion to death from any cause. The estimated rates of EFS, PFS and OS at 6 and 12 months were further evaluated.Safety was evaluated as the incidence, nature and severity of adverse effects. Adverse effects of special interest were related to CAR-T cell toxicities and included CRS and ICANS. Mortality during the study was summarized by cause of death.