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

Sponsor
Institut Paoli-Calmettes
Study ID
NCT06557421
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    complete discontinuation of Venetoclax
  • Azacitidine — DRUG
    complete discontinuation of Azacitidine

Study Details

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

Key Dates

Start date
Feb 4, 2026
Status verified
Mar 2026
Primary completion
Nov 1, 2028
Completion
Nov 1, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: VEN-AZA de-escalation
    VEN-AZA de-escalation

Primary Outcome 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. [ Time Frame: 24 months ]

Central Contacts

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