Children with newly diagnosed acute myeloid leukemia
Conditions
Interventions
The treatment group:Mitoxantrone liposome combined with cytarabine ± etoposide
Sponsors
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1. The patient's guardian understood the study procedure and voluntarily signed the informed consent (ICF).For patients =16 years old) >= 50; 5. Expected survival time >= 3 months; 6. Liver and kidney function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5 times upper limit of normal (ULN) (<= 5 times ULN for patients with liver infiltration); Total bilirubin <= 1.5 times ULN (<= 3 times ULN for patients with hepatic infiltration); Serum creatinine <= 1.5 times ULN;
Exclusion criteria
Exclusion criteria: 1. Have one of the following diagnoses: (1) AML associated with Down syndrome; (2) secondary AML; 2. Cardiac function and disease meet one of the following conditions: (1) long QTc syndrome or QTc interval >480 ms; (2) complete left bundle branch block, degree II or III atrioventricular block; (3) severe, uncontrolled arrhythmia requiring medical treatment; (4) New York College of Cardiology grade >= II; (5) cardiac ejection fraction (EF) less than 50% or below the lower limit of the study site laboratory range; (6) myocardial infarction, unstable angina, history of major unstable ventricular arrhythmia or any other arrhythmia requiring treatment, history of clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities within 6 months before enrollment. 3. Previous or current concurrent cancer (except for non-melanoma basal cell carcinoma of the skin, carcinoma in situ of the breast/cervix, and other cancers that have been effectively controlled without treatment within the past five years); 4. Uncontrolled systemic diseases (such as advanced infection, uncontrolled hypertension, diabetes, etc.); 5. Human immunodeficiency virus (HIV) infection (HIV antibody positive); 6. Hepatitis B, hepatitis C active infection (hepatitis B surface antigen or core antibody positive, plus HBV DNA, HBV DNA > 1 x 10^3 IU/mL is excluded; HCV RNA > 1x10^3 IU/mL was excluded if HCV antibody was positive). 7. A known history of immediate or delayed hypersensitivity to the same class of drugs and excipients of the study drug; 8. Severe neurological or psychiatric history; 9. Patients who, in the judgment of the investigator, were not eligible to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic characteristics of PLM after first administration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Relapse free survival;negative rate of molecular residual disease;Compound complete remission rate;safety; | — |
Countries
China
Contacts
Public ContactZhu Xiaofan
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed