drugset / Trial / NCT07672262
VA Consolidation in Intermediate-Risk AML
RandomizedParallel-groupOpen-labelTreatment
Summary
This clinical trial aims to compare the efficacy and safety of venetoclax-based consolidation therapy versus conventional consolidation chemotherapy (intermediate/high-dose cytarabine) in newly diagnosed adult patients with intermediate-risk acute myeloid leukemia (AML). Participants must have achieved complete remission (CR) or CR with incomplete hematologic recovery (CRi) after induction therapy with venetoclax and azacitidine and are planned to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Timeline
- Start
- 2026-06-01
- Primary completion
- 2030-06-01
- Completion
- 2030-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |
| Comparator | Cytarabine | Small molecule | 1 g | Intravenous |
| Comparator | Cytarabine | Small molecule | 2 g | Intravenous |
| Comparator | Cytarabine | Small molecule | 6 g | Intravenous |
| Subject | Venetoclax | Small molecule | 400 mg | Oral |