作者
Michael R Bishop, Michael Dickinson, Duncan Purtill, Pere Barba, Armando Santoro, Nada Hamad, Koji Kato, Anna Sureda, Richard Greil, Catherine Thieblemont, Franck Morschhauser, Martin Janz, Ian Flinn, Werner Rabitsch, Yok-Lam Kwong, Marie J Kersten, Monique C Minnema, Harald Holte, Esther HL Chan, Joaquin Martinez-Lopez, Antonia MS Müller, Richard T Maziarz, Joseph P McGuirk, Emmanuel Bachy, Steven Le Gouill, Martin Dreyling, Hideo Harigae, David Bond, Charalambos Andreadis, Peter McSweeney, Mohamed Kharfan-Dabaja, Simon Newsome, Evgeny Degtyarev, Rakesh Awasthi, Christopher Del Corral, Giovanna Andreola, Aisha Masood, Stephen J Schuster, Ulrich Jäger, Peter Borchmann, Jason R Westin
发表日期
2022/2/17
期刊
New England Journal of Medicine
卷号
386
期号
7
页码范围
629-639
出版商
Massachusetts Medical Society
简介
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 …
引用总数
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MR Bishop, M Dickinson, D Purtill, P Barba, A Santoro… - New England Journal of Medicine, 2022