Acute myeloid leukemia
Conditions
Interventions
Experimental group:Test preparation, daunorubicin cytosine abysaccharide liposome for injection
Control group:D1 Reference preparation,daunorubicin cytosine abysaccharide liposome for injection(Vyxeos)+Test drug
Sponsors
Hematology Hospital of Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
55 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Understand and voluntarily sign a written informed consent; 2. Aged 55 to 70 years old (inclusive); 3. Patients with untreated acute myeloid leukemia (AML) diagnosed per WHO criteria; 4. Eastern Cooperation Oncology Group (ECOG) performance status of 0~1; 5. Expected survival>=3 months; 6. Able to adhere to the study visit schedule and other protocol requirements; 7. The main organ functions meet the following criteria within 7 days prior to treatment: Systems Values of laboratory tests; Blood routine; Total white blood cell count =50% as assessed by echocardiography or cardiac scan with multiple uptake gated acquisition (MUGA); 9. QTcF at baseline or screening: male<450 ms, female<470 ms; 10. Females must agree to use adequate contraception (such as intrauterine device (IUD), contraceptives or condoms) for the duration of study participation and for 6 months following completion of the study; females should be non-lactating subjects and with negative results of serum pregnancy tests within 7 days.
Exclusion criteria
Exclusion criteria: 1. Acute promyelocytic leukemia (APL); 2. Known central nervous system (CNS) involvement with leukemia (confirmation by head magnetic resonance imaging (MRI) or cerebrospinal fluid examination is required if there are obvious symptoms or suspected involvement of central nervous system); 3. History of malignant tumors other than cured basal cell or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of cervix or breast, or focal prostate cancer with Gleason score 6; 4. Patients with prior exposures to daunorubicin or other anthracyclines, or cytarabine; 5. The interval between any treatment medication (conventional or investigational) for MDS and the first administration of this study is less than 2 weeks. However, the interval between the first medication of this study and hydroxyurea used for the purpose of inhibiting the rapid proliferation of the tumor could be >=24 hours. The toxicity of drugs for the treatment of MDS should be reduced to Grade 1 or below prior to the first dose of the study; 6. Patients who have undergone major surgery or received radiotherapy within 4 weeks before the first administration; 7. Patients who suffered from active cardiovascular diseases including but not limited to: poorly controlled hypertension (ie. systolic blood pressure >=160 mmHg and/or diastolic blood pressure >=90 mmHg) despite antihypertentsive treatment, myocardial infarction, unstable angina, uncontrolled arrhythmia, heart failure of Grade III/IV (New York Heart Association, NYHA) within 6 months before the first medication; 8. Severe blood bleeding history, such as hemophilia A , hemophilia B, von Willebrand disease or spontaneous bleeding that requires blood transfusion or other medical intervention; 9. History of stroke or intracranial hemorrhage within 6 months prior to the first medication; 10. Severe or collapsing lung disease within 2 weeks before the first administration; 11. Uncontrolled active infections (acute or chronic fungal, bacterial, viral or other infections); 12. Any severe medical reasons, laboratory abnormalities or mental illness that affect the obtaining of informed consent; 13. Patients who have severe allergic reactions to liposome preparation ingredients or intolerable adverse reactions; 14. Patients with hepatolenticular degeneration or other abnormal copper metabolism; 15. Patients with positive hepatitis B surface antigen or hepatitis B core antibody with hepatitis B viral DNA quantitive > ULN, positive hepatitis C antibody or positive HIV antibody; 16. Patients who had special diet such as grapefruit within 48 hours before the first dose of the study drug; 17. Patients have used other clinical trial drugs within 28 days prior to screening; 18. Other situations inappropriate to participate in this study according to researchers considerations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameters of D1 per cycle; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation;ORR; | — |
Countries
China
Contacts
Public ContactHongbing Ma
West China hospital, Sichuan University
Outcome results
None listed