Background:Patient outcomes are poor for aggressive B-cell non-Hodgkin's lymphomas not responding to or progressing within 12 months after first-line therapy.Tisagenlecleucel is an anti-CD19 chimeric antigen recep...Background:Patient outcomes are poor for aggressive B-cell non-Hodgkin's lymphomas not responding to or progressing within 12 months after first-line therapy.Tisagenlecleucel is an anti-CD19 chimeric antigen receptor T-cell therapy approved for diffuse large B-cell lymphoma after at least two treatment lines.Methods:We conducted an international phase 3 trial involving patients with aggressive lymphoma that was refractory to or progressing within 12 months after first-line therapy.Patients were randomly assigned to receive tisagenlecleucel with optional bridging therapy(tisagenlecleucel group)or salvage chemotherapy and autologous hematopoietic stem-cell transplantation(HSCT)(standard-care group).The primary end point was event-free survival,defined as the time from randomization to stable or progressive disease at or after the week 12 assessment or death.Crossover to receive tisagenlecleucel was allowed if a defined event occurred at or after the week 12 assessment.Other end points included response and safety.展开更多
文摘Background:Patient outcomes are poor for aggressive B-cell non-Hodgkin's lymphomas not responding to or progressing within 12 months after first-line therapy.Tisagenlecleucel is an anti-CD19 chimeric antigen receptor T-cell therapy approved for diffuse large B-cell lymphoma after at least two treatment lines.Methods:We conducted an international phase 3 trial involving patients with aggressive lymphoma that was refractory to or progressing within 12 months after first-line therapy.Patients were randomly assigned to receive tisagenlecleucel with optional bridging therapy(tisagenlecleucel group)or salvage chemotherapy and autologous hematopoietic stem-cell transplantation(HSCT)(standard-care group).The primary end point was event-free survival,defined as the time from randomization to stable or progressive disease at or after the week 12 assessment or death.Crossover to receive tisagenlecleucel was allowed if a defined event occurred at or after the week 12 assessment.Other end points included response and safety.
