{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T13:51:06Z","timestamp":1792158666633,"version":"4.4.0"},"reference-count":28,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T00:00:00Z","timestamp":1786924800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T00:00:00Z","timestamp":1786924800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Br J Haematol"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:title>Summary<\/jats:title>\n                  <jats:p>\n                    Venetoclax (VEN) plus hypomethylating agents (HMAs) represents the standard of care for newly diagnosed acute myeloid leukaemia (AML) patients unfit for intensive chemotherapy, but prospective real\u2010world observational data outside randomized clinical trials remain limited. The Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA) AML2320 is a prospective, multicentre, observational study (NCT04589728) including 193 newly diagnosed unfit AML patients receiving VEN plus azacitidine or decitabine between November 2020 and December 2021. Primary end\u2010point was overall survival (OS); secondary end\u2010points included composite complete remission (cCR), disease\u2010free survival and safety. Median age was 74\u2009years with 42% of patients being \u226575\u2009years. After completing cycle 4, cCR was achieved in 73% of the patients, with 54% responding before cycle 2. After a median follow\u2010up of 23\u2009months, median OS was 13.0\u2009months. cCR achievement within cycle 4 correlated with longer OS (19.1 vs. 9.1\u2009months,\n                    <jats:italic>p<\/jats:italic>\n                    \u2009=\u20090.001). Patients receiving 400\u2009mg VEN without azoles had improved OS compared with those on reduced doses with azoles (18.2 vs. 11.4\u2009months,\n                    <jats:italic>p<\/jats:italic>\n                    \u2009=\u20090.015). An anchored matching\u2010adjusted indirect comparison with the phase III VIALE\u2010A trial (NCT02993523) showed comparable median OS (14.8\u2009months vs. 14.9\u2009months;\n                    <jats:italic>p<\/jats:italic>\n                    \u2009=\u20090.6). The GIMEMA AML2320 trial confirmed the efficacy of VEN\/HMAs in a prospective, real\u2010world unfit population. Early remission was associated with improved outcomes.\n                  <\/jats:p>","DOI":"10.1111\/bjh.70752","type":"journal-article","created":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T01:31:18Z","timestamp":1787016678000},"page":"1735-1745","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Real\u2010world outcomes of venetoclax plus hypomethylating agents in unfit acute myeloid leukaemia: Results of the\n                    <scp>GIMEMA AML2320<\/scp>\n                    trial"],"prefix":"10.1111","volume":"209","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2855-8121","authenticated-orcid":false,"given":"Raffaele","family":"Palmieri","sequence":"first","affiliation":[{"name":"Department of Biomedicine and Prevention University of Tor Vergata  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8648-885X","authenticated-orcid":false,"given":"Alfonso","family":"Piciocchi","sequence":"additional","affiliation":[{"name":"GIMEMA Data Center Fondazione GIMEMA Franco Mandelli Onlus  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1942-1230","authenticated-orcid":false,"given":"Stefano","family":"Soddu","sequence":"additional","affiliation":[{"name":"GIMEMA Data Center Fondazione GIMEMA Franco Mandelli Onlus  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2493-7749","authenticated-orcid":false,"given":"Marco","family":"Frigeni","sequence":"additional","affiliation":[{"name":"Department of Oncology and Hematology ASST Papa Giovanni XXIII  Bergamo Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4666-3817","authenticated-orcid":false,"given":"Erika","family":"Borlenghi","sequence":"additional","affiliation":[{"name":"Department of Hematology ASST Spedali Civili di Brescia  Brescia Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8982-8079","authenticated-orcid":false,"given":"Nicola","family":"Fracchiolla","sequence":"additional","affiliation":[{"name":"SC Ematologia, Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano  Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9139-1729","authenticated-orcid":false,"given":"Maria Paola","family":"Martelli","sequence":"additional","affiliation":[{"name":"Dipartimento di Medicina e Chirurgia Universit\u00e0 di Perugia, Ospedale \u201cSanta Maria della Misericordia\u201d  Perugia Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-2518-2347","authenticated-orcid":false,"given":"Ernesta","family":"Audisio","sequence":"additional","affiliation":[{"name":"Azienda Ospedaliero\u2010Universitaria Citt\u00e0 della Salute e della Scienza di Torino  Torino Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2109-1194","authenticated-orcid":false,"given":"Alessandro","family":"Cignetti","sequence":"additional","affiliation":[{"name":"SCDU Ematologia, Ospedale Mauriziano Umberto I  Torino Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giacomo","family":"Gianfaldoni","sequence":"additional","affiliation":[{"name":"SOD Ematologia Universit\u00e0 di Firenze, AOU Careggi  Florence Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1922-5157","authenticated-orcid":false,"given":"Calogero","family":"Vetro","sequence":"additional","affiliation":[{"name":"Division of Hematology, BMT Unit AOU Policlinico G Rodolico S Marco  Catania Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0604-6934","authenticated-orcid":false,"given":"Nicola","family":"di Rienzo","sequence":"additional","affiliation":[{"name":"Haematology and Transplant Unit \u201cV. 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