Gilteritinib in Combination With Venetoclax and Azacitidine for AML Patients With FLT3 Mutations Ineligible for Intensive Treatment

Main Who May Qualify: - Newly diagnosed AML (according to WHO 2022 or ICC 2022 criteria) with a minimum BM blast count of \>=20%, excluding APL - FLT3 mutation at initial diagnosis - Ineligibility of standard induction chemotherapy - Pre-treatment with approved combination of Venetoclax + Azacitidine (one cycle only) Main Who Should NOT Join This Trial: - R/R AML - Previous treatment for AML (except HU and/or one cycle VEN+AZA according to SOC) - Previous treatment with Gilteritinib - Known active CNS involvement - QTcF \>450 ms or long QT Syndrome at screening - Treatment with concomitant strong CYP3A inducers or St. John's wort Always talk to your doctor about whether this trial is right for you.