acute myeloid leukemia
Conditions
Interventions
Cladribine:mitoxantrone cytorabine and cladribine
Sponsors
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
15 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 15 to 54 years with r AML in our hospital after Jan 15, 2014 as defined by the bone marrow cytomorphology, immunophenotyping, cytogenetics according to FAB classification and WHO classification (except APL); 2. AML is elapsed/refractory (except solitary extramedullary leukemia); 3.Male or female aged 15 to 55 years; 4. ECOG Performance status of 0,1, or 2 4; 5. Patients must have the following laboratory values( within 7 days before treatment): 1) Total bilirubin <1.5 ULN (corrected for same age); 2) AST and ALT <2.5 ULN (corrected for same ages); 3) Serum creatinine <2 ULN (corrected for same age); 4) Myocardial enzymes <2 ULN (corrected for same ages); 5) Cardiac ejection fraction determined by echocardiography within normal range; 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/refractory patients exposed to cladribine in the previous induction therapy; 2. With other blood diseases at the same starting study time (such as hemophilia and myelofibrosis). The investigates do not think it is suitable for this clinical trial; 3. Acute myeloid leukemia not otherwise categorized sub-class based on WHO, acute panmyelosis with myelofibrosis and myeloid sarcoma; 4. Patients with another primary malignancy ( requiring active intervention at the same starting study time); 5. Female who are pregnant, breast feeding or childbearing potential without a negative urine pregnancy test at screen; 6. Liver and kidney function was abnormal, beyond the inclusion criteria; 7. 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; 8. Patients with severe infections (including tuberculosis, pulmonary aspergillosis, etc); 9. AIDS or chronic hepatitis C patients; 10. Epilepsy, dementia and other mental disorders requiring drug treatment, history of non-compliance to regimens or inability to grant consent; 11. Drug abuse, medical, psychological or social conditions which may interfere with the subjects involved in research or evaluation of research results; 12. The investigator believe that patient who are not suitable for Blood Diseases Hospital, Chinese Academy of Medical Sciences and other 31 hospitals.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| mortality related to induction therapy;overall survival;relapse free survival;toxicity related to MAC regime; | — |
Primary
| Measure | Time frame |
|---|---|
| complete remission; | — |
Countries
China
Contacts
Public ContactWang Jianxiang
Outcome results
None listed