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Eligible patients had R\/R AML with <jats:italic>FLT3\u2010ITD<\/jats:italic> (aged 18\u201365 years) who were treated with VAH. The primary endpoint was composite complete remission (CRc) after two cycles. Secondary outcomes included the overall response rate (ORR), safety, and survival.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Between July 9, 2020, and March 19, 2022, 58 patients were assessed for eligibility, 51 of whom were enrolled. The median patient age was 47 years (interquartile range [IQR] 31\u201357). CRc was 76.5% with ORR of 82.4%. At a median follow\u2010up of 17.7 months (IQR, 8.7\u201324.7), the median duration of CRc was not reached (NR), overall survival was 18.1 months (95% confidence interval [CI], 11.8\u2010NR) and event\u2010free survival was 11.4 months (95% CI, 5.6\u2010NR). Grade 3 or 4 adverse events occurring in \u226510% of patients included neutropenia in 47 (92.2%), thrombocytopenia in 41 (80.4%), anemia in 35 (68.6%), febrile neutropenia in 29 (56.9%), pneumonia in 13 (25.5%), and sepsis in 6 (11.8%) patients. Treatment\u2010related death occurred in two (3.9%) patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The sorafenib plus VAH regimen was well tolerated and highly active against R\/R AML with <jats:italic>FLT3\u2010ITD<\/jats:italic>. This regimen may be a suitable therapeutic option for this population, but larger population trials are needed to be explored.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration<\/jats:title><jats:p>Clinical Trials Registry: NCT04424147<\/jats:p><\/jats:sec>","DOI":"10.1111\/joim.13738","type":"journal-article","created":{"date-parts":[[2023,10,30]],"date-time":"2023-10-30T02:58:14Z","timestamp":1698634694000},"page":"216-228","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":22,"title":["Sorafenib plus triplet therapy with venetoclax, azacitidine and homoharringtonine for refractory\/relapsed acute myeloid leukemia with <i>FLT3\u2010ITD<\/i>: A multicenter phase 2 study"],"prefix":"10.1111","volume":"295","author":[{"given":"Sijian","family":"Yu","sequence":"first","affiliation":[{"name":"Department of Hematology Nanfang Hospital Southern Medical University  Guangzhou China"},{"name":"Clinical Medical Research Center 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