drugset / Trial / NCT06928376
A Multicenter RCT of "3+7" vs Venetoclax + CACAG in Newly Diagnosed Mid/High-Risk AML Patients
Phase 2
Recruiting
160 enrolled
Chinese PLA General Hospital
940 Hospital of the People's Liberation Army Joint Logistic Support Force · collab960th Hospital of Joint Logistics Support Force of People's Liberation Army of China · collabFirst Affiliated Hospital of Harbin Medical University · collabJining First People's Hospital · collabThe General Hospital of Western Theater Command · collabYantai Yuhuangding Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to compare the efficacy and safety of venetoclax combined with the CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed intermediate- or high-risk acute myeloid leukemia (AML).
Timeline
- Start
- 2024-04-18
- Primary completion
- 2025-09-01
- Completion
- 2026-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aclacinomycin | Unknown | 20 mg | — |
| Subject | Azacitidine | Other / unclassified | 75 mg/m2 | — |
| Subject | Cytarabine | Small molecule | 75 mg/m2 | — |
| Subject | Cytarabine | Small molecule | 100 mg/m2 | — |
| Comparator | Daunorubicin | Small molecule | 60 mg/m2 | — |
| Comparator | Idarubicin | Small molecule | 8 mg/m2 | — |
| Comparator | Idarubicin | Small molecule | 10 mg/m2 | — |
| Subject | Tucidinostat | Small molecule | 30 mg | — |
| Subject | Venetoclax | Small molecule | 400 mg | — |
| Background | Granulocyte colony-stimulating factor | Protein / enzyme biologic | 300 ug | — |