Explore the best tolerable and efficacious dose of Gilteritinib when combined with standard treatment with Venetoclax and Azacitidine in AML patients with FLT3 mutations which are ineligible for intensive chemotherapy
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)
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