FLT3-ITD Targeted Therapy in Fit AML Patients

Newly diagnosed AML patients deemed fit by the investigator to receive intensive chemotherapy will be screened for FLT3-ITD mutation. Eligible patients will be randomized in a 1:1 ratio between experimental and control arms, stratified by age and WBC at diagnosis:

* Participants assigned to the experimental arm will receive a triplet regimen consisting of VEN, AZA, and gilteritinib, administered for up to 12 cycles. This will be followed by up to 12 additional cycles of AZA in combination with gilteritinib, and subsequently up to 12 cycles of gilteritinib monotherapy * Participants in the control arm will be treated following the local standard of care, consisting of induction with '7+3', consolidation with high-dose cytarabine, and maintenance with a FLT3 inhibitor (midostaurin, quizartinib, or sorafenib) as per local practice.

Participants in the experimental arm with an available donor should proceed to HSCT based on the local investigator's judgement, but this should not occur prior to the end of cycle 2. For participants in the control group, HSCT is as per the local investigator's judgement, but recommended in first CR/CRi.

For patients with no available donor and not proceeding to HSCT, treatment in the experimental arm is recommended to continue for a minimum of 6 cycles before transitioning to maintenance treatment with AZA and gilteritinib.

Following HSCT, patients in the experimental arm will receive gilteritinib maintenance for up to 36 cycles and in the control arm, FLT3-inhibitor as per local standard of care (i.e., midostaurin, quizartinib or sorafenib).