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

Study acronym: STOP VEN
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Start date changed from estimate of Jun 12, 2025 to Feb 4, 2026v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Nov 1, 2024 to Jun 12, 2025
    • Study sites: 0 to 1
    v3
  3. Primary endpoint revised
    • Secondary endpoints revised (13)
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06557421
Lead Sponsor Institut Paoli-Calmettes
Conditions
(from sponsor)		 Acute Myeloid Leukemia
Related terms Leukemia, Myeloid, Acute
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov