Multicenter Phase II Clinical Study of the research on optimal assessments and treatment strategy of nilotinib in newly diagnosed chronic myelogenous leukemia patients in the chronic phase (CML-CP) based on early achievement of complete molecular response (CMR); N-road
Phase 2
- Conditions
- Chronic Myelogenous Leukemia
- Registration Number
- JPRN-UMIN000008565
- Lead Sponsor
- Cooperative study between Jikei University Kashiwa Hospital and Shimousa Hematology Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
1.Previously treated by tyrosine kinase inhibitors other than imatinib 2.Previously received imatinib for more than 2 weeks 3.Previous treatment experience with IFN-alpha 4.Received oral anticancer drugs such as hydroxyurea for more than 3 months. 5.Confirmed to have the T315I point mutation of BCR-ABL 6.History of hematopoietic stem cell transplantation 7.Patients with cardiovascular dysfunction 8.Other uncontrolled complications. 9.Pregnant women or those with suspected pregnancy. Nursing women and those who plan to become pregnant during the study period.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method