Status:
RECRUITING
De-Escalation Study Evaluating Venetoclax and Azacitidine Discontinuation in AML Responding Patients
Lead Sponsor:
Institut Paoli-Calmettes
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 st...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06557421
Start Date
June 12 2025
End Date
November 1 2028
Last Update
June 18 2025
Active Locations (1)
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1
Institut Paoli-Calmettes
Marseille, France, 13273