Adult patients with acute myeloid leukemia
Conditions
Interventions
A:Standard-dose HAD for induction therapy
B:intermediate dose HAD for induction therapy
C:High-dose Ara-C for consolidation therapy
D:intermediate dose Ara-c with anthracycline for consolidation therapy
Sponsors
Hospital of Blood Diseases, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
15 Years to 54 Years
Inclusion criteria
Inclusion criteria: 1. AML patients aged 15 to 54 years with newly diagnosed in the 31 study centers after August 1, 2010 as defined by the bone marrow cytomorphology, immunophenotyping, cytogenetics according to FAB classification and WHO classification (except APL); 2. Male or female, 54 > Age (years) >= 15; 3. ECOG Performance status of 0,1, or 2; 4. Patients must have the following laboratory values( within 7 days before treatment); 1) Total bilirubin 60 ml/min; 4) Myocardial enzymes <2 ULN (corrected for same ages); 5) Cardiac ejection fraction determined by echocardiography within normal range; 5. To be able to swallow or per os; 6. Patients must complete the all listed screening assessment; 7. Patient must sign the informed consent prior to any study related screening procedures being performed.
Exclusion criteria
Exclusion criteria: Subjects who meet the standards of any of following shall not be enrolled in the study: 1. Relapsed patients; 2. Secondary leukemia; 3. With other blood diseases at the same starting study time; 4. Acute myeloid leukemia not otherwise categorized sub-class based on WHO, acute panmyelosis with myelofibrosis and myeloid sarcoma; 5. Patients with another primary malignancy ( requiring active intervention at the same starting study time); 6. Female who are pregnant, breast feeding or childbearing potential without a negative urine pregnancy test at screen; 7. Liver and kidney function was abnormal, beyond the inclusion criteria; 8. Active heart disease, defined as one or more of the following: 1) Uncontrolled or symptoms angina; 2) Myocardial infarction within past 6 months; 3) History of need drug therapy or severe clinical symptoms arrhythmia; 4) Uncontrolled or symptomatic congestive heart failure (> NYHA grade 2); 5) Ejection fraction lower than the lower limit of normal range; 9. Patients with severe infections (including tuberculosis, pulmonary aspergillosis, etc); 10. AIDS or chronic hepatitis C patients; 11. Have the evidence of CNS infiltration when AML is diagnosed; 12. Epilepsy, dementia and other mental disorders requiring drug treatment, history of non-compliance to regimens or inability to grant consent; 13. Drug abuse, medical, psychological or social conditions which may interfere with the subjects involved in research or evaluation of research results; 14. The investigator believe that patient who are not suitable for Blood Diseases Hospital, Chinese Academy of Medical Sciences and other 31 hospitals.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of complete release (CR);Disease free survival;Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of recurrence;Mortality; | — |
Countries
China
Contacts
Public ContactJianxiang Wang
Outcome results
None listed