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

Recruiting now · Phase 2

Conditions studied: Acute Myeloid Leukemia

In brief

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

Key facts

Study ID

NCT06557421

Run by

Institut Paoli-Calmettes

People needed

50

Starts

2026-02-04

Expected to finish

2028-11-01

Last updated by the study team

2026-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• Institut Paoli-Calmettes — Marseille, France (enrolling)

Full record on ClinicalTrials.gov

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