NCT06557421RecruitingPhase 2
De-Escalation Study Evaluating Venetoclax and Azacitidine Discontinuation in AML Responding Patients
Source: ClinicalTrials.gov · Last updated 13 Mar 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 9 Aug 2024
- Start date
- 4 Feb 2026
- Primary completion date
- 1 Nov 2028
- Lead sponsor
- Institut Paoli-Calmettes
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT06557421
- EU CT number
- 2024-514112-28-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From 4 Feb 2026 to the primary completion date, 1 Nov 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Centre Hospitalier Universitaire De Nantes Coordinator of this site? Confirm its status | Nantes Cedex 1 | France | Recruiting |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Recruiting |
| Centre Hospitalier Universitaire De Bordeaux Coordinator of this site? Confirm its status | Talence | France | Recruiting |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.