De-Escalation Study Evaluating Venetoclax and Azacitidine Discontinuation in AML Responding Patients

Inclusion criteria

1. Female/Male ≥ 18 years of age; 2. Diagnosis of previously untreated AML according to the 2022 International Consensus Classification of Myeloid Neoplasms and Acute Leukemias; 3. VEN-AZA given as first-line treatment; 4. Duration of VEN-AZA therapy of 12 months (+/- 28 days), regardless of duration of VEN-AZA cycles and the doses; 5. Patients in first composite complete remission (CRc) defined as complete remission (CR) or CR with incomplete hematologic recovery (CRi) or CR with partial hematologic recovery (CRh); 6. Absence of detectable minimal residual disease (MRD) performed locally (i.e. MRDneg defined as MCF MRD \<0.1% of CD45 expressing cells with the target immunophenotype in bone marrow, or NPM1 or RUNX1-RUNX1T1 or CBFB-MYH11 MRD copy numbers \<0.1% in the blood); 7. ECOG \<3; 8. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; 9. Affiliated to the French Social Security or beneficiary of such a health Insurance; 10. Signed informed consent. Non inclusion Criteria: 1. VEN-AZA given as salvage therapy; 2. Prior allogeneic stem cell transplant; 3. Discontinuation of treatment because of absence or loss of response; 4. Patient in emergency situation or unable to give consent; 5. Severe medical or mental condition precluding the follow up procedures after treatment discontinuation.