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

Sequential Gilteritinib in Combination With Venetoclax and Azacitidine for Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) and FLT3 Mutations Ineligible for Intensive Treatment

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

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