{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,9]],"date-time":"2025-12-09T08:30:26Z","timestamp":1765269026247,"version":"3.44.0"},"reference-count":50,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2025,6,10]],"date-time":"2025-06-10T00:00:00Z","timestamp":1749513600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100003196","name":"Ministero della Salute","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100003196","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004326","name":"Bayer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004326","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100011218","name":"Sandoz","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100011218","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Br J Haematol"],"published-print":{"date-parts":[[2025,8]]},"abstract":"<jats:title>Summary<\/jats:title><jats:p>Treatment options for relapsed\/refractory (R\/R) diffuse large B\u2010cell lymphoma (DLBCL) patients ineligible for autologous stem cell transplant (ASCT) or chimeric antigen receptor (CAR)\u2010T\u2010cell therapy remain limited. The PI3K inhibitor copanlisib has shown activity as a single agent in DLBCL. This phase II, single\u2010arm, multicentre trial evaluated copanlisib with rituximab and bendamustine (copa\u2010BR) in ASCT\u2010 and CAR\u2010T\u2010ineligible R\/R DLBCL. Patients received six cycles of copa\u2010BR, followed by up to 12\u2009cycles of copanlisib maintenance. The primary end\u2010point was 12\u2010month progression\u2010free survival (PFS). Thirty\u2010seven patients (aged 68\u201387\u2009years, R\/R after 1\u20132 prior lines) were enrolled. The overall response rate was 24.3%, with complete responses in 13.5%. After a median follow\u2010up of 20\u2009months, the 12\u2010month PFS and overall survival rates were 25.1% and 44.5% respectively. Grade \u22653 toxicities included neutropenia (56.8%), infections (27.0%, including 6 death due to COVID\u201019 infection with 25% fatality) and thrombocytopenia (16.2%). Due to limited efficacy, poor tolerability and emerging alternative treatments, the trial was terminated prematurely. Copa\u2010BR showed limited activity and an unfavourable safety profile, discouraging further investigation of this combination in ASCT\u2010 and CAR\u2010T\u2010ineligible R\/R DLBCL.<\/jats:p>","DOI":"10.1111\/bjh.20204","type":"journal-article","created":{"date-parts":[[2025,6,12]],"date-time":"2025-06-12T11:23:55Z","timestamp":1749727435000},"page":"445-454","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Copanlisib in combination with rituximab and bendamustine for transplant\u2010ineligible relapsed\/refractory diffuse large B\u2010cell lymphoma patients: Results from the phase <scp>II<\/scp> multicentre <scp>FIL<\/scp> Copa\u2010<scp>BR<\/scp> trial from Fondazione Italiana Linfomi (<scp>FIL<\/scp>)"],"prefix":"10.1111","volume":"207","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5127-3653","authenticated-orcid":false,"given":"Mattia","family":"Novo","sequence":"first","affiliation":[{"name":"SC Ematologia, AOU Citt\u00e0 della Salute e della Scienza di Torino  Torino Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pio Manlio Mirko","family":"Frascione","sequence":"additional","affiliation":[{"name":"Candiolo Cancer Institute, FPO\u2010IRCCS  Candiolo (Torino) Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1922-9054","authenticated-orcid":false,"given":"Alessia","family":"Castellino","sequence":"additional","affiliation":[{"name":"Hematology Unit Santa Croce e Carle Hospital  Cuneo Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Luigi","family":"Marcheselli","sequence":"additional","affiliation":[{"name":"Fondazione Italiana Linfomi  Modena Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Samantha Deianira","family":"Dattoli","sequence":"additional","affiliation":[{"name":"Fondazione Italiana Linfomi  Modena Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Margherita","family":"Vannucchi","sequence":"additional","affiliation":[{"name":"Pathology Unit, Department of Medical Biotechnology University of Siena  Siena Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Delia","family":"Rota\u2010Scalabrini","sequence":"additional","affiliation":[{"name":"Candiolo Cancer Institute, FPO\u2010IRCCS  Candiolo (Torino) Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alessandra","family":"Tucci","sequence":"additional","affiliation":[{"name":"Department of Hematology ASST Spedali Civili  Brescia Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5934-3943","authenticated-orcid":false,"given":"Guido","family":"Gini","sequence":"additional","affiliation":[{"name":"Hematology, Department of Clinical and Molecular Sciences Marche Polytechnic University  Ancona Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Giuseppe","family":"Tarantini","sequence":"additional","affiliation":[{"name":"Haematology and BMT Unit Monsignor R. Dimiccoli Hospital  Barletta Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Donato","family":"Mannina","sequence":"additional","affiliation":[{"name":"Oncology\u2010Hematology Department, Hematology Unit Azienda Ospedaliera Papardo  Messina Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5337-5947","authenticated-orcid":false,"given":"Annalisa","family":"Arcari","sequence":"additional","affiliation":[{"name":"Hematology Unit Guglielmo da Saliceto Hospital  Piacenza Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Arcangelo","family":"Liso","sequence":"additional","affiliation":[{"name":"Hematology\/Oncology Unit Terni Hospital, University of Perugia  Terni Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elisabetta","family":"Scarpa","sequence":"additional","affiliation":[{"name":"Hematology Ca Foncello Hospital  Treviso Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dario","family":"Marino","sequence":"additional","affiliation":[{"name":"Oncology 1 Unit, Department of Oncology Veneto Institute of Oncology IOV\u2010IRCCS  Padova Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michele","family":"Spina","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology and Immune\u2010Related Tumors Centro di Riferimento Oncologico di Aviano (CRO) IRCCS  Aviano Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ausilia","family":"Gorgone","sequence":"additional","affiliation":[{"name":"UOC Ematologia ARNAS Garibaldi  Catania Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicola","family":"Di Renzo","sequence":"additional","affiliation":[{"name":"Department of Hematology and Stem Cell Transplant Presidio Ospedaliero Vito Fazzi  Lecce Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Salvatrice","family":"Mancuso","sequence":"additional","affiliation":[{"name":"Hematology Unit, PROMISE Department University of Palermo  Palermo Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Luigi","family":"Petrucci","sequence":"additional","affiliation":[{"name":"Hematology, Department of Translational and Precision Medicine Policlinico Umberto 1\/Sapienza University of Rome  Rome Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Agostino","family":"Tafuri","sequence":"additional","affiliation":[{"name":"Hematology University Hospital Sant'Andrea  Rome Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Barbara","family":"Botto","sequence":"additional","affiliation":[{"name":"SC Ematologia, AOU Citt\u00e0 della Salute e della Scienza di Torino  Torino Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francesca","family":"Bonello","sequence":"additional","affiliation":[{"name":"Candiolo Cancer Institute, FPO\u2010IRCCS  Candiolo (Torino) Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elisa","family":"Santambrogio","sequence":"additional","affiliation":[{"name":"SC Ematologia, AOU Citt\u00e0 della Salute e della Scienza di Torino  Torino Italy"},{"name":"Hematology Unit Santa Croce e Carle Hospital  Cuneo Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7772-2747","authenticated-orcid":false,"given":"Umberto","family":"Vitolo","sequence":"additional","affiliation":[{"name":"Candiolo Cancer Institute, FPO\u2010IRCCS  Candiolo (Torino) Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,6,10]]},"reference":[{"key":"e_1_2_13_2_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.1998.16.8.2780"},{"key":"e_1_2_13_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199309303291402"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2006-08-038257"},{"key":"e_1_2_13_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa011795"},{"key":"e_1_2_13_6_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2005.05.1003"},{"key":"e_1_2_13_7_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2010-03-276246"},{"key":"e_1_2_13_8_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2017-03-769620"},{"key":"e_1_2_13_9_1","doi-asserted-by":"publisher","DOI":"10.1038\/bmt.2016.213"},{"key":"e_1_2_13_10_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2013.53.9593"},{"key":"e_1_2_13_11_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1707447"},{"key":"e_1_2_13_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1804980"},{"key":"e_1_2_13_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)31366-0"},{"key":"e_1_2_13_14_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2116133"},{"key":"e_1_2_13_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(22)00662-6"},{"key":"e_1_2_13_16_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2012.46.5203"},{"key":"e_1_2_13_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00277-013-1879-x"},{"key":"e_1_2_13_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1349-7006.2011.01994.x"},{"key":"e_1_2_13_19_1","doi-asserted-by":"publisher","DOI":"10.3109\/10428194.2015.1106536"},{"key":"e_1_2_13_20_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.19.00172"},{"key":"e_1_2_13_21_1","doi-asserted-by":"publisher","DOI":"10.1182\/bloodadvances.2021005953"},{"key":"e_1_2_13_22_1","article-title":"Real\u2010world outcomes of relapsed\/refractory diffuse large B\u2010cell lymphoma treated with polatuzumab vedotin\u2010based therapy","volume":"6","author":"Argnani L","year":"2022","journal-title":"Hema"},{"key":"e_1_2_13_23_1","doi-asserted-by":"publisher","DOI":"10.1182\/bloodadvances.2020004155"},{"key":"e_1_2_13_24_1","doi-asserted-by":"publisher","DOI":"10.1177\/20406207211006027"},{"key":"e_1_2_13_25_1","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdx289"},{"key":"e_1_2_13_26_1","doi-asserted-by":"publisher","DOI":"10.1002\/ajh.25711"},{"key":"e_1_2_13_27_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41375-020-0743-y"},{"key":"e_1_2_13_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(21)00145-5"},{"key":"e_1_2_13_29_1","doi-asserted-by":"publisher","DOI":"10.1002\/hon.2439_187"},{"key":"e_1_2_13_30_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2013.54.8800"},{"key":"e_1_2_13_31_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0959-8049(01)00448-8"},{"key":"e_1_2_13_32_1","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1097-0258(19990330)18:6<695::AID-SIM60>3.0.CO;2-O"},{"key":"e_1_2_13_33_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.2021012251"},{"key":"e_1_2_13_34_1","doi-asserted-by":"publisher","DOI":"10.1182\/bloodadvances.2021005794"},{"key":"e_1_2_13_35_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0609.2007.00996.x"},{"key":"e_1_2_13_36_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00280-009-0941-9"},{"key":"e_1_2_13_37_1","doi-asserted-by":"publisher","DOI":"10.3324\/haematol.2013.090597"},{"key":"e_1_2_13_38_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(20)30225-4"},{"key":"e_1_2_13_39_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.2023021274"},{"key":"e_1_2_13_40_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2023-173143"},{"key":"e_1_2_13_41_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2023-173456"},{"key":"e_1_2_13_42_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2206913"},{"key":"e_1_2_13_43_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.22.01725"},{"key":"e_1_2_13_44_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.18.00915"},{"key":"e_1_2_13_45_1","doi-asserted-by":"publisher","DOI":"10.1080\/10428194.2020.1855344"},{"key":"e_1_2_13_46_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2015-12-683516"},{"key":"e_1_2_13_47_1","doi-asserted-by":"publisher","DOI":"10.1097\/HS9.0000000000000039"},{"key":"e_1_2_13_48_1","doi-asserted-by":"publisher","DOI":"10.2147\/BLCTT.S309171"},{"key":"e_1_2_13_49_1","unstructured":"GormleyN.Oncologic Drugs Advisory Committee Meeting FDA Introductory Comments.2022. Available from:www.fda.gov. Accessed 8 October 2024"},{"key":"e_1_2_13_50_1","unstructured":"Bayer provides update on Aliqopa\u00ae (copanlisib) | Bayer United States. Available from:https:\/\/www.bayer.com\/en\/us\/news\u2010stories\/update\u2010on\u2010aliqopar. Accessed 8 October 2024"},{"key":"e_1_2_13_51_1","doi-asserted-by":"publisher","DOI":"10.1182\/bloodadvances.2024013236"}],"container-title":["British Journal of Haematology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bjh.20204","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,8,28]],"date-time":"2025-08-28T07:04:45Z","timestamp":1756364685000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/bjh.20204"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,6,10]]},"references-count":50,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2025,8]]}},"alternative-id":["10.1111\/bjh.20204"],"URL":"https:\/\/doi.org\/10.1111\/bjh.20204","archive":["Portico"],"relation":{},"ISSN":["0007-1048","1365-2141"],"issn-type":[{"type":"print","value":"0007-1048"},{"type":"electronic","value":"1365-2141"}],"subject":[],"published":{"date-parts":[[2025,6,10]]},"assertion":[{"value":"2025-03-25","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-05-29","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-06-10","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}