drugset / Trial / NCT06668558
Venetoclax + Azacitidine in Patients With Acute Myeloid Leukemia
Phase 2
Recruiting
29 enrolled
Spanish Cooperative Group for the Study and Treatment of Acute Leukemias and Myelodysplasias
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The VERDI study is an investigator-initiated, multicenter, multicohort, phase II trial with combination of venetoclax + azacitidine for patients treated for AML under according to an intensive chemotherapy protocol (CETLAM-20) failing to achieve or maintain MRD negativity at pre-established time-points: at chemotherapy completion for ELN favorable subtypes, and prior to alloHCT for non-favorable European LeukemiaNet (ELN) AML patients. The primary objective is to determine Ven/Aza treatment activity in MRD clearance in patients diagnosed with AML with persistent MRD or MRD reappearance after frontline chemotherapy, or prior to alloHCT.
Timeline
- Start
- 2024-12-16
- Primary completion
- 2028-06
- Completion
- 2028-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 75 mg/m2 | — |
| Subject | Venetoclax | Small molecule | 400 mg | — |