drugset / Trial / NCT07486479
Venetoclax, Azacitidine, and Mitoxantrone Hydrochloride Liposome Versus Idarubicin and Cytarabine in Newly Diagnosed AML
Phase 3
Not yet recruiting
204 enrolled
The First Affiliated Hospital of Soochow University
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study aims to evaluate the efficacy and safety of venetoclax combined with azacitidine and mitoxantrone hydrochloride liposome (MVA) versus idarubicin combined with cytarabine (IA) in the treatment of newly diagnosed AML.
Timeline
- Start
- 2026-03-10
- Primary completion
- 2026-12-31
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |
| Comparator | Cytarabine | Small molecule | 100 mg/m2 | Intravenous |
| Comparator | Idarubicin | Small molecule | 12 mg/m2 | Intravenous |
| Subject | Mitoxantrone hydrochloride liposome | Unknown | 24 mg/m2 | Intravenous |
| Subject | Venetoclax | Small molecule | 400 mg | Oral |