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Abstract Combination of FLT3 inhibitors with azacitidine and venetoclax has promising activity in FLT3-mutated acute myeloid leukemia (AML). In this phase I/II study, we evaluated the safety and efficacy of an all-oral regimen of decitabine/cedazuridine, venetoclax, and gilteritinib in adults with FLT3-mutated AML and other myeloid malignancies. A total of 46 patients were enrolled (19 with newly diagnosed [ND] AML and 27 with relapsed/refractory [R/R] disease).
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