Acute Myeloid Leukemia (AML)
Conditions
Interventions
Intervention group:Mitoxantrone hydrochloride liposome injection combined with decitabine, aglycone cytarabine (D-CMG) regimen
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
60 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients were fully informed about the study, participated voluntarily and signed an informed consent form (ICF); 2.Age 60-75 years, male or female, expected survival > 3 months; 3.Histologically confirmed acute myeloid leukemia (not M3). Previously untreated and unable to receive standard cytarabine and anthracycline induction regimens due to age or comorbidities or patient's preference; 4.Estimated creatinine clearance >= 30 mL/min; 5.AST and ALT <=3.0 x ULN (unless considered to be due to leukemic organ involvement and bilirubin <= 1.5 x ULN (unless considered to be due to leukemic organ involvement); 6.ECOG <= 2;
Exclusion criteria
Exclusion criteria: 1.Acute promyelocytic leukemia (APL) and with low-risk cytogenetics such as t(8;21), inv(16), or t(16;16); 2.Active central nervous system leukemia; 3.History of myeloproliferative neoplasms (MPN), including myelofibrosis, essential thrombocythemia, true erythrocytosis, chronic myelogenous leukemia (CML) with or without BCR-ABL1 translocation, and AML with BCR-ABL1 translocation; 4.HIV-positive patients and/or active HBV or HCV infection (documented by positive HBV-DNA and HCV-RNA tests); 5.Patients with clinically significant QTc interval prolongation (>450 ms in men and >470 ms in women), ventricular tachycardia and atrial fibrillation, second-degree heart block, history of myocardial infarction and congestive heart failure within 1 year of enrollment, and coronary artery disease requiring pharmacologic therapy for clinical symptoms. 6.Active, uncontrolled, severe infection. 7.History of other malignancy within 2 years, except: adequately treated carcinoma in situ of the cervix or breast; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; 8.White blood cell count > 25 x 10^9/L (Hydroxyurea or leukapheresis may fulfill this criterion; 9.Mental disorders that would prevent research participation; 10.Any other condition in which the investigator believes the patient should not participate in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose (MTD) of PLM; | — |
Countries
China
Contacts
Public ContactBingXu
The First Affiliated Hospital of Xiamen University
Outcome results
None listed