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

Main Inclusion Criteria: * 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 Exclusion Criteria: * 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