drugset / Trial / NCT06621199
Mitoxantrone Hydrochloride Liposome in Combination With Cytarabine and Venetoclax Regimen in Newly Diagnosed Elderly AML
Phase 2
Recruiting
42 enrolled
First Affiliated Hospital of Zhejiang University
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a phase 2 study to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome in combination with cytarabine and venetoclax (MAV) regimen in newly diagnosed elderly AML. To account, conservatively, for a 10% dropout rate before study completion, we planned to include 42 patients. The primary endpoint is 2-year event free survival(EFS).
Timeline
- Start
- 2024-07-08
- Primary completion
- 2027-12-31
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cytarabine | Small molecule | 100 mg/m2 | — |
| Subject | Mitoxantrone | Small molecule | 24 mg/m2 | — |
| Subject | Venetoclax | Small molecule | 400 mg | — |