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However, evidence on large sets of patients is lacking, especially in relapsed or refractory leukemia.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>AVALON is a multicentric cohort study that was conducted in Italy on patients with AML who received venetoclax\u2010based therapies from 2015 to 2020. The study was approved by the ethics committee of the participating institution and was conducted in accordance with the Declaration of Helsinki. The effectiveness and toxicity of venetoclax\u00a0+\u00a0HMA in 190 (43 newly diagnosed, 68 refractory, and 79 relapsed) patients with AML are reported here.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In the newly diagnosed AML, the overall response rate and survival confirmed the brilliant results demonstrated in VIALE\u2010A. In the relapsed or refractory AML, the combination demonstrated a surprisingly complete remission rate (44.1% in refractory and 39.7% in relapsed evaluable patients) and conferred to treated patients a good expectation of survival. Toxicities were overall manageable, and most incidents occurred in the first 60\u00a0days of therapy. Infections were confirmed as the most common nonhematologic adverse event.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Real\u2010life data show that the combination of venetoclax and HMA offers an expectation of remission and long\u2010term survival to elderly, newly diagnosed patients, and to relapsed or chemoresistant AML, increasing the chance of cure through a different mechanism of action. The venetoclax\u00a0+\u00a0HMA combination is expected to constitute the base for triplet combinations and integration of target therapies. Our data contribute to ameliorate the understanding of venetoclax\u00a0+\u00a0HMA effectiveness and toxicities in real life.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cncr.34608","type":"journal-article","created":{"date-parts":[[2023,1,24]],"date-time":"2023-01-24T09:58:32Z","timestamp":1674554312000},"page":"992-1004","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":51,"title":["AVALON: The Italian cohort study on real\u2010life efficacy of hypomethylating agents plus venetoclax in newly diagnosed or relapsed\/refractory patients with acute myeloid leukemia"],"prefix":"10.1002","volume":"129","author":[{"given":"Elisabetta","family":"Todisco","sequence":"first","affiliation":[{"name":"Divisione di Oncoematologia IRCCS Istituto Europeo di Oncologia  Milano Italy"},{"name":"SC Ematologia Ospedale Busto Arsizio ASST Valle Olona  Varese Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristina","family":"Papayannidis","sequence":"additional","affiliation":[{"name":"IRCCS Azienda Ospedaliero\u2010Universitaria di Bologna Istituto di Ematologia \u201cSer\u00e0gnoli\u201d  Bologna Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicola","family":"Fracchiolla","sequence":"additional","affiliation":[{"name":"UOC Oncoematologia Fondazione IRCCS \u201cCa\u2019Granda\u201d Ospedale Maggiore Policlinico  Milano Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisabetta","family":"Petracci","sequence":"additional","affiliation":[{"name":"Unit\u00e0 di Biostatistica e Clinical Trials IRCCS Istituto Romagnolo per lo Studio dei Tumori (ISRT) \u201cDino Amadori\u201d  Meldola Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chiara","family":"Zingaretti","sequence":"additional","affiliation":[{"name":"Unit\u00e0 di Biostatistica e Clinical Trials IRCCS Istituto Romagnolo per lo Studio dei Tumori (ISRT) \u201cDino Amadori\u201d  Meldola Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Calogero","family":"Vetro","sequence":"additional","affiliation":[{"name":"Divisione di Ematologia AOU Policlinico \u201cG. 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