{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T11:07:50Z","timestamp":1789988870506,"version":"4.0.1"},"reference-count":14,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2024,5,6]],"date-time":"2024-05-06T00:00:00Z","timestamp":1714953600000},"content-version":"vor","delay-in-days":5,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Hematological Oncology"],"published-print":{"date-parts":[[2024,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:label\/><jats:p>Venetoclax, a highly selective BCL\u20102 inhibitor, combined with hypomethylating agents (HMAs) azacitidine or decitabine, is approved for the treatment of newly diagnosed acute myeloid leukemia (ND AML) in patients who are ineligible to receive intensive chemotherapy. Previous clinical studies initiated venetoclax plus HMA in an inpatient setting owing to concerns of tumor lysis syndrome (TLS). This study (NCT03941964) evaluated the efficacy and safety of venetoclax plus HMA in a United States community\u2013based outpatient setting in patients with ND AML (<jats:italic>N<\/jats:italic>\u00a0=\u00a060) who were treatment na\u00efve for AML, ineligible to receive intensive chemotherapy, had no evidence of spontaneous TLS at screening, and were deemed as appropriate candidates for outpatient initiation of venetoclax plus HMA by the investigator. Patients received venetoclax in combination with azacitidine (75\u00a0mg\/m<jats:sup>2<\/jats:sup>) or decitabine (20\u00a0mg\/m<jats:sup>2<\/jats:sup>) for up to 6 cycles during the study. With a median time on study of 18.3\u00a0weeks, the best response rate of composite complete remission was 66.7%, and the overall post\u2010baseline red blood cell (RBC) and platelet transfusion independence rate was 55.0%, consistent with results of studies in which treatment was initiated in an inpatient setting. Key adverse events included nausea, anemia, thrombocytopenia, neutropenia, and white blood cell count decrease of any grade (\u226550% of patients). The observed safety profile was generally consistent with that of venetoclax plus HMA observed in inpatient AML studies. With close monitoring, 2 cases of TLS were identified, appropriately managed, and the patients were able to continue study treatment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Clinical Trials Registration<\/jats:title><jats:p>This study is registered at ClinicalTrials.gov. The registration identification number is NCT03941964.<\/jats:p><\/jats:sec>","DOI":"10.1002\/hon.3274","type":"journal-article","created":{"date-parts":[[2024,5,7]],"date-time":"2024-05-07T05:14:50Z","timestamp":1715058890000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["A phase 3b study of venetoclax and azacitidine or decitabine in an outpatient setting in patients with acute myeloid leukemia"],"prefix":"10.1002","volume":"42","author":[{"given":"Sudhir","family":"Manda","sequence":"first","affiliation":[{"name":"Arizona Oncology The US Oncology Network  Tucson Arizona USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"III","given":"Bertrand M.","family":"Anz","sequence":"additional","affiliation":[{"name":"Tennessee Oncology  Chattanooga Tennessee USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher","family":"Benton","sequence":"additional","affiliation":[{"name":"Rocky Mountain Cancer Centers The US Oncology Network  Englewood Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E. 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