De novo Ph+ Acute Lymphoblastic Leukemia
Conditions
Interventions
A group:Nilotinib plus chemotherapy
Sponsors
Hospital of Blood Diseases, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. De novo Ph+ ALL patients aged 18 to 60 years after JUN 1ST, 2010 diagnosed by the bone marrow cytomorphology, immunophenotyping, cytogenetics molecular biology according to WHO classification; 2. Male or female, 60 > Age (years) >=18; 3. ECOG Performance status of 0, 1, or 2; 4. Patients must have the following laboratory values: (1) Total bilirubin 45%; (7) Serum K, Mg, P >=1 LLN. 5. 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. Heart disfunction: left ventricular ejection fraction450s, it must be checked under nonrmal blood electrolytes; myocardial infarction in 2 years before inclusion; ohter serious heart diseases such as unstable angina, congestive heart-failure, uncontrolled hypertension and arrhythmia; 3. Other serious or life threatening diseases; Patients with another primary malignancy (requiring active intervention at the same starting study time); hepatitis, serious pancreatic or kidney disease; 4. Female who are pregnant, breast feeding or childbearing potential without a negative urine pregnancy test at screen; 5. HIV patients; 6. hereditary galactosum intolerance, serious galactosum deficiency or lactose malabsorption; 7. Taking other experimental agents in 30 dyas before inclusion; 8. Drug abuse, medical, psychological or social conditions which may interfere with the subjects involved in research or evaluation of research results; 9. The investigator believe that patient who are not suitable, 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);Overall survival; | — |
Countries
China
Contacts
Public ContactJianxiang Wang
Outcome results
None listed