drugset / Trial / NCT06810791
HVA vs IA/DA or VA in the Treatment of ND HR-AML
Phase 3
Recruiting
876 enrolled
Nanfang Hospital, Southern Medical University
Affiliated Hospital of Guangdong Medical University · collabDongguan People's Hospital · collabFirst Affiliated Hospital of Gannan Medical University · collabFirst Affiliated Hospital of Guangxi Medical University · collabFirst People's Hospital of Chenzhou · collabFirst People's Hospital of Foshan · collabGanzhou City People's Hospital · collabGuangdong Provincial Hospital of Traditional Chinese Medicine · collabGuangdong Second Provincial General Hospital · collabGuangzhou First People's Hospital · collabHuizhou Municipal Central Hospital · collabHunan Provincial People's Hospital · collabJiangmen Central Hospital · collabPeople's Hospital of Guangxi Zhuang Autonomous Region · collabShenzhen Hospital of Southern Medical University · collabShenzhen Second People's Hospital · collabSun Yat-Sen Memorial Hospital of Sun Yat-Sen University · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim of this study is to evaluate the safety and efficacy of homohartonine combined with venetoclax and azacitidine (HVA) versus intensive chemotherapy (IA/DA) or venetoclax combined with azacitidine (VA) in newly diagnosed high-risk AML patients.
Timeline
- Start
- 2025-01-01
- Primary completion
- 2026-06-30
- Completion
- 2026-12-31
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 | Homoharringtonine | Small molecule | 1 mg/m2 | Intravenous |
| Comparator | Idarubicin | Small molecule | 12 mg/m2 | Intravenous |
| Subject | Venetoclax | Small molecule | 400 mg | Oral |