The goal of this clinical trial is to test efficacy and safety of a VENETOCLAX-AZACITIDINE (VEN-AZA) de-escalation strategy in Acute Myeloid Leukemia responding patients. The main objectives of the study are:
* Evaluation of the efficacy of VEN-AZA de-escalation strategy by measuring the effect of VEN-AZA discontinuation in term of Disease-Free Survival. * Evaluation of the other efficacy parameters and safety of VEN-AZA de-escalation strategy.
Patients from the prospective study will be compared to a retrospective cohort of patients who will be selected on the basis of identical eligibility criteria.
Participants will:
* Stop VEN-DASA treatment * Be closely monitored by regular evaluation of the disease
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;
None
Single group
Venetoclax
Drugcomplete discontinuation of Venetoclax
Azacitidine
Drugcomplete discontinuation of Azacitidine
Disease-Free Survival, measured from inclusion (VEN-AZA de-escalation) to the date of morphologic or measurable residual disease relapse or death from any cause, whichever occurs first.
Absolute duration of hematologic response, defined as the time from inclusion to relapse or death.
Absolute duration of negative measurable residual disease response, defined as the time from inclusion to measurable residual disease relapse or death.
Cumulative incidence of relapse, defined as the probability of relapse over time.
Overall survival, defined as the time from inclusion (VEN-AZA de-escalation) to death.
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