drugset / Trial / NCT06621212
Mitoxantrone Hydrochloride Liposome, Standard-dose of Cytarabine and Venetoclax in the Treatment of R/R AML
Phase 2
Recruiting
72 enrolled
First Affiliated Hospital of Zhejiang University
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this prospective, multi-center, single-arm, phase 2 study is to evaluate the efficacy and safety of a combination regimen of mitoxantrone hydrochloride liposome injection, standard-dose of cytarabine and venetoclax (MAV) in the treatment of relapsed or refractory (R/R) AML. The study plan to enroll 72 R/R AML patients who are expected to receive laboratory tests of bone marrow and blood specimens at regular times after MAV treatment.
Timeline
- Start
- 2024-07-05
- Primary completion
- 2026-12-31
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cytarabine | Small molecule | 100 mg/m2 | — |
| Subject | Mitoxantrone | Small molecule | 30 mg/m2 | — |
| Subject | Venetoclax | Small molecule | 400 mg | — |