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RECRUITING
NCT06557421
PHASE2

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

Sponsor: Institut Paoli-Calmettes

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-02-04

Completion Date

2028-11-01

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DRUG

Venetoclax

complete discontinuation of Venetoclax

DRUG

Azacitidine

complete discontinuation of Azacitidine

Locations (1)

Institut Paoli-Calmettes

Marseille, France