drugset / Trial / NCT06557421

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

NCT06557421 ↗

Phase 2 Recruiting 50 enrolled Institut Paoli-Calmettes
NaSingle-groupOpen-labelTreatment

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

Timeline

Start
2026-02-04
Primary completion
2028-11-01
Completion
2028-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified — —
Subject Venetoclax Small molecule — —