Addition of autologous stem-cell transplantation to an ibrutinib-containing first-line treatment in patients aged 18–65 years with mantle cell lymphoma (TRIANGLE): 4·5-year follow-up of a three-arm, randomised, open-label, phase 3 superiority trial of the European MCL Network

作者：Martin Dreyling, Martin Dreyling, Jeanette Doorduijn, Eva Soca Giné, Mats Jerkeman, Jan Walewski, Martin Hutchings, Ulrich Mey, Jon Riise, Marek Trneny, Vibeke K J Vergote, Ofer Shpilberg, MG Silva, Sirpa Leppä, Linmiao Jiang, Stephan Stilgenbauer, Andrea Kerkhoff, Ron D Jachimowicz, Georg Heß, Tom van Meerten, Stefan Wirths, Peter Herhaus, Urban Novak, Judith Dierlamm, Mathias Hänel, Christine Hanoun, Kristina Sonnevi, Carlo Visco, Daniela Donnarumma, Andrés J M Ferreri, Caterina Patti, Piero Maria Stefani, Christiane Pott, Wolfram Klapper, Christian Schmidt, Michael Unterhalt, Tobias Tix, Marco Ladetto, Eva Hoster, Alexandra Albertsson Lindblad, Virginia Amador, Guilherme Brasil Duffles Amarante, Luca Arcaini, Rebecca Auer, Igor Aurer, Avigdor Abraham, Irit Avivi, Enver Aydilek, Sandra Bašić-Kinda, Silvia Bea, Úna Bhreathnach, Mark Bishton, Sebastian Böttcher, Paul Bröckelmann, Peter‐Martin Bruch, Barbara Burroni, Juan Carlos Caballero Hernaez, José Cabeçadas, Mary Callanan, Elias Campo, Vit Campr, Morgane Cheminant, Jianbang Chiang, Annalisa Chiappella, David Chiron, Sergio Cogliatti, Dolors Colomer, Sergio Cortelazzo, Francesca Cordero, Giorgio Alberto Croci, Mette Dahl, Marie‐Hélène Delfau‐Larue, Fatih Demırkan, Michael Dickinson, Sascha Dietrich, Monika Długosz-Danecka, Jeanette Doorduijn, Snježana Dotlić, Barbara Dreta, Martin Dreyling, Martin Dreyling, Sara Ek, Ezzat ElHassadi, Zachary D. Epstein‐Peterson, Dr Toby Eyre, Martin Fehr, Simone Ferrero, E Forsgren, Elise Genuardi, Daniele Grimaldi, Eva Soca Giné, Ingrid Glimelius, Döndü Gözel, MG Silva, Rashmi S. Goswami, Katja Gutmair, Eliza Hawkes, Olivier Hermine, Stephanie Herold, Elisabeth Hoenig, Georg Hess, Eva Hoster, Martin Hutchings, Sunil Iyengar, Marta Illenyi, Ron Jachimowic, Haaber Christensen Jacob, Mats Jerkeman, Linmiao Jiang, Wojciech Jurczak, Sophie Kaltenbach, Mouhamad Khouja, Won Seog Kim, Eva Kimby, Wolfram Klapper, Pavel Klener, Sofia Klint, Anita Kumar, John Kuruvilla, Marco Ladetto, Agnes List, Lavanya Lokhande, Yannick Le Bris, Steven Le Gouill, Georg Lenz, David Lewis, Kim Linton, Cathalina Lisson, Armando López Guillermo, Elisa Lucchini, Marco Lucioni, Elizabeth Macintyre, Kami J. Maddocks, Danielle Maitrepierre, Ana Marín‐Niebla, Amira Marouf, Maurizio Martelli, Peter Martin, Joana Matos Rodrigues de, Christopher Melani, Ulrich Mey, Michael Mian, Szabolcs Modok, Riccardo Moia, Filipa Moita, Anna Nikkarinen, James Nolan, Urban Novak, Anke Ohler, Lina Olsson, German Ott, Marco Paulli, Simone Pernice, Patricia Pérez Galán, Kathrin Philipp‐Abbrederis, Christiane Pott, Jan Preetesh, Fiona Quinn, Leticia Quintanilla-Martinez de Fend, Tysel Phillips, Simone Ragaini, Hilka Rauert‐Wunderlich, Sarah Reinke, Vincent Ribrag, Oshrat Rokah, Irina-Gabriele Rosu, Emmanuelle Robert-Eydoux, Joanna Romejko-Jarosinska, Mark Roschewski, Andreas Rosenwald, Gaël Roué, Silvia Ruiz, Martina Rudelius, Grzegorz Rymkiewicz, Birgitta Sander, Clémentine Sarkozy, Gabriel Scheubeck, Christian Schmidt, Maria Teresa Scupoli, Ofer Shpilberg, Björn Silkenstedt, Elisabeth Silkenstedt, Linda Simon, Christine Stephan, Michał Szymczyk, Rita Tavarozzi, Benoît Tessoulin, Catherine Thieblemont, Lorenz Thurner, Marie‐Kristin Tilch, Maria Chiara Tisi, Tobias Tix, Marek Trneny, Aurore Touzard, Selvin Tove, Gloria Turri, Michael Unterhalt, Elisabeth Vandenberghe, Vincent H.J. Van der Velden, Tom van Meerten, Theodoros Vassilakopoulos, Vibeke Vergote, Diego Villa, Carlo Visco, Umberto Vitolo, Andrej Vranovský, Vladan Vucinic, Karin I.N. Fahl Wader, Jan Walewski, Oliver Weigert, Michael Williams, Sabine Witt, Kazuhito Yamamoto, Francesco Zaja · 发表于：The Lancet · 年份：2026 · DOI：10.1016/s0140-6736(26)00362-4 · 被引用次数：9 · 研究领域：Chronic Lymphocytic Leukemia Research、Lymphoma Diagnosis and Treatment、Cutaneous lymphoproliferative disorders research

Background Adding ibrutinib to standard, first-line immunochemotherapy improves failure-free survival in adult patients aged 18–65 years with mantle cell lymphoma, according to the first results from the TRIANGLE trial. With prolonged follow-up, we investigated whether the addition of autologous stem-cell transplantation (ASCT) to an ibrutinib-containing regimen improves failure-free survival, and evaluated effects on overall survival. Methods We conducted a three-arm, randomised, open-label, phase 3 superiority trial (TRIANGLE) in 165 secondary or tertiary clinical centres, with experience in mantle cell lymphoma treatment and the capability to perform ASCT or an association with such a centre, in 13 European countries and Israel. Patients aged 18–65 years with untreated, stage II–IV mantle cell lymphoma and suitable for ASCT were randomly assigned (1:1:1) to control group A or experimental groups A + I or I. Randomisation was done using computer-generated random numbers and stratified by study groups and Mantle Cell Lymphoma International Prognostic Index risk groups. Treatment in group A consisted of six alternating, 21-day cycles of R-CHOP (intravenous rituximab 375 mg/m 2 on day 0 or 1, cyclophosphamide 750 mg/m 2 on day 1, doxorubicin 50 mg/m 2 on day 1, vincristine 1·4 mg/m 2 on day 1 [up to a maximum of 2 mg], and oral prednisone 100 mg on days 1–5) and R-DHAP or R-DHAOx (intravenous rituximab 375 mg/m 2 on day 0 or 1, intravenous or oral dexamethasone 40 mg on days 1...