drugset / Trial / NCT06557421
De-Escalation Study Evaluating Venetoclax and Azacitidine Discontinuation in AML Responding Patients
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | — | — |
| Subject | Venetoclax | Small molecule | — | — |