About this trial
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
Eligibility criteria
Qualifiers
The patient fully understands this study, voluntarily participates and signs an informed consent form (ICF);
Age: 18-75 years old (including boundary values of 18 and 75);
Treatment related AML
Previously had a history of MDS
Disqualifiers
Individuals who have previously received mitoxantrone or mitoxantrone liposomes;
Previously received treatment with doxorubicin or other anthracyclines, with a total cumulative dose of doxorubicin>360mg/m2 (1mg of doxorubicin is equivalent to 2mg of doxorubicin or 0.5mg of doxorubicin);
Within 4 weeks prior to the first use of the study drug or within 5 half-lives of the drug, the patient has received anti-tumor treatment including surgery, chemotherapy, targeted therapy, or participated in other clinical trials and received clinical trial medication;
Long QTc syndrome or QTc interval>480ms;
Trial design
Treatments tested in this trial
- CMGV
Treatment groups
Sponsors and collaborators
Ruijin Hospital
Lead sponsor
Huadong Hospital
Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Huashan Hospital
Collaborator
Army Medical Center of PLA
Collaborator
Sun Yat-sen University
Collaborator
RenJi Hospital
Collaborator
Shanghai Jiading District Central Hospital
Collaborator
The Second Affiliated Hospital of Dalian Medical University
Collaborator
First Hospital of China Medical University
Collaborator
Dalian Municipal Central Hospital
Collaborator
Shanghai Zhongshan Hospital
Collaborator
Shanghai Pudong Hospital
Collaborator
Shanghai Public Health Clinical Center
Collaborator
Xuhui Central Hospital, Shanghai
Collaborator
The Affiliated People's Hospital of Ningbo University
Collaborator
Taizhou First People's Hospital
Collaborator
Wenzhou People's Hospital
Collaborator