Clinical Trial

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

Study acronym: STOP VEN
Recruiting Phase 2
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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 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
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-08-13; most recent amendment 2026-03-11.
Status change: Not Yet Recruiting → Recruiting 2025-06-13
Trial Details
NCT Number NCT06557421
Lead Sponsor Institut Paoli-Calmettes
Conditions Acute Myeloid Leukemia
Enrollment 50 participants
Start Date 2026-02-04
Primary Completion 2028-11-01 (estimated)
Study Completion 2028-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-13