Acute Myelogenous Leukemia
Conditions
Interventions
study group:Subcutaneous administration of cytarabine
Control group: Intravenous administration of cytarabine
Sponsors
The First affiliated Hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
15 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) Informed consent signed by the patient or legally authorized representative; (2) Conformed acute myeloid leukemia according to WHO classification (except for M3), including AML transformed from myelodysplastic syndrome; (3) Aged 15–60 years; (4) WHO performance status of 2 or less; (5) adequate liver and renal function (serum bilirubin concentration=35 µmol/L, aspartate aminotransferase and alanine amino transferase concentrations less than two times the upper limit of normal, serum creatinine concentration =177 umol/L); (6) normal cardiac function (left ventricular ejection fraction =50%); (7) Anticipatory survival =3 months.
Exclusion criteria
Exclusion criteria: (1) Acute promyelocytic leukemia; (2) Patients with other cancers in the last 5 years; (3) Serum bilirubin concentration >35 umol/L, aspartate aminotransferase and alanine amino transferase concentrations more than two times the upper limit of normal, serum creatinine concentration >177 umol/L; (4) HIV positive; (5) WHO performance status of 3 or more; (6) Patients with other severe diseases such as heavy pneumonia, uncontrolled diabetes mellitus or severe heart failure; (7) Systemic conditions not suitable for chemotherapy; (8) patients who were pregnant (for women of childbearing age, ß-subunit of human chorionic gonadotropin was tested) or breastfeeding; (9) patients who could not understand or comply with the protocol; (10) AML transformed from MPN or therapy-related AML.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The complete remission rate of induction chemotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-years event free survival;3-years overall survival;Adverse events; | — |
Countries
China
Contacts
Public ContactJie Jin
The First affiliated Hospital, School of Medicine, Zhejiang University
Outcome results
None listed