Clinical trial · Interventional
De-Escalation Study Evaluating Venetoclax and Azacitidine Discontinuation in AML Responding Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine | Drug | Azacitidine | ALIAS |
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- VEN-AZA de-escalation
- description
- VEN-AZA de-escalation
- interventionNames
- Drug: Venetoclax
- Drug: Azacitidine
Primary outcomes (1)
- measure
- 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.
- timeFrame
- 24 months
Secondary outcomes (13)
- measure
- Absolute duration of hematologic response, defined as the time from inclusion to relapse or death.
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female/Male ≥ 18 years of age; 2. Diagnosis of previously untreated AML according to the 2022 International Consensus Classification of Myeloid Neoplasms and Acute Leukemias; 3. VEN-AZA given as first-line treatment; 4. Duration of VEN-AZA therapy of 12 months (+/- 28 days), regardless of duration of VEN-AZA cycles and the doses; 5. 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); 6. 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); 7. ECOG \<3; 8. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; 9. Affiliated to the French Social Security or beneficiary of such a health Insurance; 10. Signed informed consent. Non inclusion Criteria: 1. VEN-AZA given as salvage therapy; 2. Prior allogeneic stem cell transplant; 3. Discontinuation of treatment because of absence or loss of response; 4. Patient in emergency situation or unable to give consent; 5. Severe medical or mental condition precluding the follow up procedures after treatment discontinuation.
References
Publications (0)
Data not yet available