drugset / Trial / NCT05939180
VA vs DA for Newly Diagnosed Hig-risk AML
RandomizedParallel-groupOpen-labelTreatment
Summary
This is an open-label, multicenter, phase 2b, randomized study aiming to compare the efficacy and safety of venetoclax plus azacytidine Versus daunorubicin plus cytarabine (conventional 7+3 regimen) in adult acute myeloid leukemia (AML) patients with adverse risk featuress. Participants will be 1:1 randomly assigned to the VA and DA groups. Once remission was achieved, consolidated chemotherapy will be performed and allogeneic hematopoietic stem cell transplantation is strongly recommended. After completion of the study intervention, participants will be followed-up every 1 to 2 months for up to 2 years.
Timeline
- Start
- 2024-04-01
- Primary completion
- 2025-10-01
- Completion
- 2027-10-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |
| Comparator | Cytarabine | Small molecule | 100 mg/m2 | Intravenous |
| Comparator | Daunorubicin | Small molecule | 60 mg/m2 | Intravenous |
| Subject | Venetoclax | Small molecule | 400 mg | Oral |