drugset / Trial / NCT06068621
Venetoclax Plus CACAG Regimen for Newly Diagnosed Acute Myeloid Leukemia
Phase 2
Completed
200 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 · collabAir Force Military Medical University, China · collabFirst Hospital of China Medical University · collabPeople's Liberation Army (PLA) Strategic Support Force Characteristic Medical Center · collabThe General Hospital of Northern Theater Command · 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 CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed acute myeloid leukemia.
Timeline
- Start
- 2023-03-01
- Primary completion
- 2024-05-31
- Completion
- 2025-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aclacinomycin | Unknown | 20 mg | — |
| Subject | Azacytidine | 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 | 100 mg | — |
| Subject | Venetoclax | Small molecule | 200 mg | — |
| Subject | Venetoclax | Small molecule | 400 mg | — |
| Background | Granulocyte colony-stimulating factor | Protein / enzyme biologic | 300 ug | — |