https://m2.mtmt.hu/ hun 2026-05-31 09:17 JournalArticle 31386187 VALIDATED true Hématologie, Hospices Civils de Lyon and Université de Lyon, Lyon, France Medizinische Klinik und Poliklinik II, Universitätsklinik Würzburg, Würzburg, Germany Department of Hematology, Institut Catalá d'Oncologia, Hospital Duran i Reynals, Institut d'Investigacio Biomedica de Bellvitge, Barcelona, Spain Service d'Hématologie Clinique et de Thérapie Cellulaire, Centres Hospitalier Universitaire Estaing, Clermont-Ferrand, France Maria Skłodowska-Curie National Institute of Oncology, Kraków, Poland Università degli Studi di Perugia, Azienda Ospedaliera Santa Maria di Terni, Terni, Italy 1st Department of Internal Medicine, Semmelweis University, Budapest, Hungary Department of Hemato-Oncology, Palacký University and University Hospital, Olomouc, Czech Republic Division of Hematology, Department of Translational Medicine, Università del Piemonte Orientale Amedeo Avogadro, Novara, Italy Department of Haematology, Université Catholique de Louvain, CHU UCL Namur, Yvoir, Belgium Molecular and Clinical Cancer Medicine, University of Liverpool and The Clatterbridge Cancer Centre, Liverpool, United Kingdom Department of Medicine III, University Hospital Groβhadern, Ludwig Maximilians University, Munich, Germany MorphoSys, Planegg, Germany Department of Internal Medicine, Arthur G James Comprehensive Cancer Center, The Ohio State University, Columbus, OH, United States Cited By :122 Export Date: 19 April 2022 CODEN: LOANB Correspondence Address: Salles, G.; Hospices Civils de Lyon, France; email: gilles.salles@chu-lyon.fr Chemicals/CAS: creatinine, 19230-81-0, 60-27-5; gamma glutamyltransferase, 85876-02-4; lenalidomide, 191732-72-6; tafasitamab, 1422527-84-1; Antibodies, Monoclonal, Humanized; Lenalidomide; tafasitamab 0 false 2026-05-20T02:46:06.967+0000 2020-12-23T12:34:15.619+0000 2020-07-22T13:14:59.480+0000 true 10071338 Molnár-Taga Márta /api/admin/10071338 Admin true 2025-06-16T17:30:45.639+0000 2025-06-16T17:30:45.639+0000 2020-10-13T08:53:20.625+0000 true 10062250 Molnár-Taga Márta /api/admin/10062250 Admin true 10062250 2020-12-08T02:50:24.792+0000 true 565 WoS import /api/admin/565 Admin true true false true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle true 10000059 Article true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle /api/subtype/10000059 Szakcikk SubType 101 true 10000059 true 1 /api/category/1 Category true 1 Salles, G. Tafasitamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, phase 2 study true true /api/journal/10001287 REVIEWED true false 10001287 false 10001287 true 1470-2045 1474-5488 Journal FOREIGN 21 7 978 988 978 11 2020 Background: Patients with relapsed or refractory diffuse large B-cell lymphoma who are ineligible for autologous stem-cell transplantation have poor outcomes and few treatment options. Tafasitamab (MOR208) is an Fc-enhanced, humanised, anti-CD19 monoclonal antibody that has shown preclinical and single-agent activity in patients with relapsed or refractory B-cell malignancies. Preclinical data suggested that tafasitamab might act synergistically with lenalidomide. We aimed to assess the antitumour activity and safety of tafasitamab plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma who were ineligible for autologous stem-cell transplantation. Methods: In this multicentre, open-label, single-arm, phase 2 study (L-MIND), patients older than 18 years with histologically confirmed diffuse large B-cell lymphoma, who relapsed or had refractory disease after previous treatment with one to three systemic regimens (with at least one anti-CD20 therapy), were not candidates for high-dose chemotherapy and subsequent autologous stem-cell transplantation, had an Eastern Cooperative Oncology Group performance status of 0–2, and had measurable disease at baseline were recruited from 35 academic and community hospitals in ten countries. Patients received coadministered intravenous tafasitamab (12 mg/kg) and oral lenalidomide (25 mg/day) for up to 12 cycles (28 days each), followed by tafasitamab monotherapy (in patients with stable disease or better) until disease progression. The primary endpoint was the proportion of patients with an objective response (centrally assessed), defined as a complete or partial response according to the 2007 International Working Group response criteria for malignant lymphoma. Antitumour activity analyses are based on all patients who received at least one dose of both tafasitamab and lenalidomide; safety analyses are based on all patients who received at least one dose of either study medication. Recruitment is complete, and the trial is in follow-up. This trial is registered with ClinicalTrials.gov, NCT02399085. Findings: Between Jan 18, 2016, and Nov 15, 2017, 156 patients were screened: 81 were enrolled and received at least one dose of either study medication, and 80 received at least one dose of both tafasitamab and lenalidomide. Median follow-up was 13·2 months (IQR 7·3–20·4) as of data cutoff on Nov 30, 2018. 48 (60%; 95% CI 48–71) of 80 patients who received tafasitamab plus lenalidomide had an objective response: 34 (43%; 32–54) had a complete response and 14 (18%; 10–28) had a partial response. The most common treatment-emergent adverse events of grade 3 or worse were neutropenia (39 [48%] of 81 patients), thrombocytopenia (14 [17%]), and febrile neutropenia (ten [12%]). Serious adverse events occurred in 41 (51%) of 81 patients. The most frequently reported serious adverse events (in two or more patients) were pneumonia (five [6%]), febrile neutropenia (five [6%]), pulmonary embolism (three [4%]), bronchitis (two [2%]), atrial fibrillation (two [2%]), and congestive cardiac failure (two [2%]). Interpretation: Tafasitamab in combination with lenalidomide was well tolerated and resulted in a high proportion of patients with relapsed or refractory diffuse large B-cell lymphoma ineligible for autologous stem-cell transplantation having a complete response, and might represent a new therapeutic option in this setting. 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src="/frontend/resources/grid/publication-citation-icon.png"> <div class="autype autype0"> <span class="author-name" >Salles G. ✉ </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Duell J. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >González Barca E. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Tournilhac O. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Jurczak W. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Liberati A.M. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10024022"><a href="/gui2/?type=authors&mode=browse&sel=10024022" target="_blank">Nagy Z. (<span class="authorship-author-name">Nagy Zsolt</span> <span class="authorAux-mtmt"> Belgyógyászat, endokrinológia, hematológia</span>) </a> </span> <span class="author-affil"><span title="Semmelweis Egyetem">SE</span>/<span title="Általános Orvostudományi Kar">AOK</span>/<span title="Klinikum">K</span>/Belgyógyászati és Onkológiai Klinika</span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Obr A. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Gaidano G. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >André M. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Kalakonda N. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Dreyling M. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Weirather J. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Dirnberger-Hertweck M. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Ambarkhane S. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Fingerle-Rowson G. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Maddocks K. </span> </div> </div> <div class="title"><a href="/gui2/?mode=browse&params=publication;31386187" target="_blank">Tafasitamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, phase 2 study</a></div> <div> <span class="journal-title">LANCET ONCOLOGY</span> <span class="journal-issn">(<a target="_blank" href="https://portal.issn.org/resource/ISSN/1470-2045">1470-2045</a> <a target="_blank" href="https://portal.issn.org/resource/ISSN/1474-5488">1474-5488</a>)</span>: <span class="journal-volume">21</span> <span class="journal-issue">7</span> <span class="page"> pp 978-988 </span> <span class="year">(2020)</span> </div> <div class="pub-footer"> <span class="language" xmlns="http://www.w3.org/1999/html">Nyelv: Angol | </span> <span class="identifiers"> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="10.1016/S1470-2045(20)30225-4" target="_blank" href="https://doi.org/10.1016/S1470-2045%2820%2930225-4"> DOI </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="000545328900035" target="_blank" href="https://www.webofscience.com/wos/woscc/full-record/000545328900035"> WoS </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="85086663162" target="_blank" href="http://www.scopus.com/record/display.url?origin=inward&eid=2-s2.0-85086663162"> Scopus </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="32511983" target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=32511983&dopt=Abstract"> PubMed </a> </span> </span> <OnlyViewableByAuthor><div class="ratings"> <div class="journal-subject">Folyóirat szakterülete: Scopus - Oncology&nbsp;&nbsp;&nbsp;SJR indikátor:&nbsp;D1</div> </div></OnlyViewableByAuthor> <div class="publication-citation" style="margin-left: 0.5cm;"> <span title="Nyilvános idézőközlemények összesen, említések nélkül" class="citingPub-count">Nyilvános idéző összesen: 487</span> | Független: 443 | Függő: 44 | Nem jelölt: 0 | WoS jelölt: 454 | Scopus jelölt:&nbsp;432 | WoS/Scopus jelölt:&nbsp;487 | DOI jelölt:&nbsp;478 (Nem nyilvános:&nbsp;3) </div> <div class="publication-citation"> <a target="_blank" href="/api/publication?cond=citations.related;eq;31386187&sort=publishedYear,desc&sort=title"> Idézett közlemények száma: 1 </a> </div> <div class="mtid"><span class="long-pub-mtid">Közlemény: 31386187</span> | <span class="status-data status-VALIDATED"> Egyeztetett </span> Forrás Idéző | <span class="type-subtype">Folyóiratcikk ( Szakcikk ) </span> | <span class="pub-category">Tudományos</span> | <span class="publication-sourceOfData">Scopus</span> </div> <div class="notDuplums"><a target="_blank" href="/api/publication/31386187/notduplums">2 Nem duplumnak jelölés</a> </div> <div class="lastModified">Utolsó módosítás: 2020.12.23. 13:34 Szuper Admin (admin) </div> <pre class="comment" style="margin-top: 0; margin-bottom: 0;"><u>Megjegyzés</u>: Hématologie, Hospices Civils de Lyon and Université de Lyon, Lyon, France Medizinische Klinik und Poliklinik II, Universitätsklinik Würzburg, Würzburg, Germany Department of Hematology, Institut Catalá d'Oncologia, Hospital Duran i Reynals, Institut d'Investigacio Biomedica de Bellvitge, Barcelona, Spain Service d'Hématolog...</pre> </div></div>