drugset / Trial / NCT07512700
Venetoclax Combined With CACAG Regimen Versus "3+7" Regimen in the Treatment of Acute Monocytic Leukemia
Phase 2
Recruiting
204 enrolled
Chinese PLA General Hospital
Air Force Medical Center of PLA · collabPLA Strategic Support Force's Characteristic Medical Center · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is a multicenter, randomized, prospective Phase II clinical trial designed to compare the effectiveness of two treatment approaches for patients with acute monocytic leukemia.
Timeline
- Start
- 2025-09-01
- Primary completion
- 2028-09-30
- Completion
- 2029-10-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aclacinomycin | Unknown | 20 mg | Intravenous |
| Subject | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |
| Subject | Cytarabine | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 100 mg/m2 | Intravenous |
| Comparator | Daunorubicin | Small molecule | 60 mg/m2 | Intravenous |
| Comparator | Idarubicin | Small molecule | 8 mg/m2 | — |
| Comparator | Idarubicin | Small molecule | 10 mg/m2 | — |
| Comparator | Mitoxantrone | Small molecule | 12 mg/m2 | — |
| Subject | Tucidinostat | Small molecule | 30 mg | Oral |
| Subject | Venetoclax | Small molecule | 100 mg | Oral |
| Subject | Venetoclax | Small molecule | 400 mg | Oral |
| Background | Granulocyte colony-stimulating factor | Protein / enzyme biologic | 300 ug | Subcutaneous |