About this trial
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
Eligibility criteria
Qualifiers
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;
Disqualifiers
None
Trial design
Treatments tested in this trial
- Venetoclax
- Azacitidine