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

Inclusion criteria

• Female/Male ≥ 18 years of age;
• Diagnosis of previously untreated AML according to the 2022 International Consensus Classification of Myeloid Neoplasms and Acute Leukemias;
• VEN-AZA given as first-line treatment;
• Duration of VEN-AZA therapy of 12 months (+/- 28 days), regardless of duration of VEN-AZA cycles and the doses;
• 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);
• 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);
• ECOG <3;
• Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
• Affiliated to the French Social Security or beneficiary of such a health Insurance;
• Signed informed consent.

Non inclusion Criteria:

• VEN-AZA given as salvage therapy;
• Prior allogeneic stem cell transplant;
• Discontinuation of treatment because of absence or loss of response;
• Patient in emergency situation or unable to give consent;
• Severe medical or mental condition precluding the follow up procedures after treatment discontinuation.