This international, multicenter, randomized (1:1), open-label phase II/III trial will evaluate the efficacy and safety of gilteritinib combined with azacitidine and venetoclax (experimental arm) versus standard "7+3" induction plus a FLT3inhibitor (quizartinib or midostaurin) (control arm) in newly diagnosed FLT3-ITD mutated AML patients eligible for intensive chemotherapy.
Newly diagnosed AML cytopathologically confirmed according to the 5th WHO classification
Age between 18 and 75 years
FLT3-ITD mutation as per local IVDR-compliant testing. Positivity is defined as a FLT3-ITD / FLT3-wild type (WT) ratio of ≥ 0.05 (5%))
Eligibility for standard induction chemotherapy
Acute promyelocytic leukemia (APL)
BCR-ABL positive leukemia or Ph1-positive chronic myeloid leukemia
History of myeloproliferative neoplasm (MPN), including myelofibrosis, essential thrombocythemia, polycythemia vera
Active central nervous system involvement by AML
European Organisation for Research and Treatment of Cancer - EORTC
Lead sponsor
Fondazione GIMEMA
Collaborator
Astellas Pharma Inc
Collaborator