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
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
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;
Single group
CMGV
DrugInitial treatment induction therapy: CMG+Vineclavone regimen Mitoxantrone liposomes 15mg/m2, iv, d1; Cytarabine 10mg/m2, H, q12h, d1-7; G-CSF starts at 5ug/kg, H, d0, WBC ≥ 30 × 109/L, stop G-CSF; Vinecla 100mg, 2200mg, 3400mg, d4-10. Every 4 weeks is a cycle, for a total of 2 cycles. For patients with CR/CRI/MLFS/PR in the first cycle, repeat this regimen for consolidation treatment once (the second course of treatment is Vineclavone 400mg d1-7). Follow up treatment: Patients who meet the transplantation criteria will undergo hematopoietic stem cell transplantation, while those who do not undergo transplantation will continue to receive CMG+Vineclavone consolidation for 4-6 courses.
CRc
CR (complete remission)+CRi (CR with incomplete recovery of hematological counts)
ORR
Objective Response Rate
OS
Overall Survival
RFS
Relapse-free survival
MRD-
Assessable residual lesion (MRD) conversion rate to negative
Click on the lead sponsor to view all of their trials.
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
