Chronic myelogenous leukemia
Conditions
Interventions
1:Domistic made imatinib
2:Generic Imatinib
Sponsors
Peking University Peoples Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. 18 to 65 years of age, males or females; 2. Patients in chronic phase of chronic myelogenous leukemia within 6 months of diagnosis. Diagnosis of CML-CP should be based on bone marrow aspiration and/or bone marrow biopsy; 3. Voluntarily attend the study with written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Radiographically or pathologically documented extramedullary leukemic involvement (including skin, CNS, lymphoid nodule, or bone)with exception of splenomegaly; 2. Platelets=75×10^9/L; 3. Specific treatment for CML prior to study entry is not allowed with the exception of hydroxyurea and/or anagrelide; 4. Impaired hepatic or renal function, defined as followings: ? AST and/or ALT>2.5×ULN; ? BIL>1.5×ULN; ? Scr>1.5×ULN; 5. Pregnant or breast feeding women, or females with pregnancy planning; 6. Cooperative Oncology Group performance status (ECOG PS)=3; 7. Patients with serious cardiac diseases, including histories of acute myocardial infarction within 6 months before the study entry or grade III/IV cardiac insufficiency as defined by New York Heart Association Criteria; 8. Major surgeries within 4 weeks before study entry; 9. History of another primary malignancy within five years before the study entry; 10. Patients with mental disorders who could not be compliant to treatment or follow-up; 11. History of hypersensitivity to active ingredient or excipients of imatinib; 12. Participating any other clinical study concurrently; 13. Any other conditions which make the patient unsuitable for this study, as judged by investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| six-month CCyR rate; | — |
Countries
China
Contacts
Public ContactQian Jiang
Peking University Peoples Hospital
Outcome results
None listed