A Prospective, Multicenter, and Exploratory Study of CMGV in the Treatment of Recurrent Adult AML and MDS-EB-2/Elder AML

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRuijin Hospital

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

78 Participants
are divided into 1 treatment group

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