drugset / Trial / NCT06329999
A Prospective, Multicenter, and Exploratory Study of CMGV in the Treatment of Recurrent Adult AML and MDS-EB-2/Elder AML
Recruiting
78 enrolled
Ruijin Hospital
Army Medical Center of PLA · collabDalian Municipal Central Hospital · collabFirst Hospital of China Medical University · collabHuadong Hospital · collabHuashan Hospital · collabRenJi Hospital · collabShanghai General Hospital, Shanghai Jiao Tong University School of Medicine · collabShanghai Jiading District Central Hospital · collabShanghai Public Health Clinical Center · collabShanghai Pudong Hospital · collabShanghai Zhongshan Hospital · collabSun Yat-sen University · collabTaizhou First People's Hospital · collabThe Affiliated People's Hospital of Ningbo University · collabThe Second Affiliated Hospital of Dalian Medical University · collabWenzhou People's Hospital · collabXuhui Central Hospital, Shanghai · collab
NaSingle-groupOpen-labelTreatment
Summary
The goal of this clinical trial\] is to evaluate mitoxantrone hydrochloride liposomes, subcutaneous injection of cytarabine and G-CSF combined with Venetoclax (CMG+Ven) in adult secondary acute myeloid leukemia and myelodysplastic syndrome with increased primordial cells type 2(MDS-IB2) or elderly acute myeloid leukemia\]. The main questions it aims to answer are: * Evaluation of the efficacy * Evaluation of the safety
Timeline
- Start
- 2024-02-03
- Primary completion
- 2025-12-31
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cytarabine | Small molecule | 10 mg/m2 | Subcutaneous |
| Subject | Mitoxantrone | Small molecule | 15 mg/m2 | Intravenous |
| Subject | Venetoclax | Small molecule | 100 mg | — |
| Subject | Venetoclax | Small molecule | 400 mg | — |
| Subject | Venetoclax | Small molecule | 2200 mg | — |
| Subject | Venetoclax | Small molecule | 3400 mg | — |
| Background | G-CSF | Unknown | 5 ug/kg | Subcutaneous |