Safety of quitting imatinib in Japanese chronic myelogenous leukemia patients
Phase 2
Recruiting
- Conditions
- chronic myelogenous leukemia
- Registration Number
- JPRN-UMIN000003939
- Lead Sponsor
- Department of Clinical and Experimental Hematology, University of Tsukuba
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
1. Patients in whom other treatments including transplantation are more eligible than this protocol 2. Patients who was previously administrated with IFN-alpha 3. Patients who have a history of allergic reaction to vaccines and other biologicals 4. Patients who were previously administered with Shyosaikoto 5. Patients who have autoimmune hepatitis 6. Patients who are pregnant or who expect to be pregnant during the study period 7. Patients in depression 8. Patients who have cytogenetic abnormalities if Ph chromosome is negative at the registration 9. Patients whose physician in charge judges inappropriate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ratio of maintaining CMR 24 months after stopping imatinib
- Secondary Outcome Measures
Name Time Method 1. ratio of maintaining CMR without relapse 24 months after stopping imatinib 2. cumulative ratio of relapse within 24 months after stopping imatinib 3. ratio of CMR achievement within 12 months after stopping IFN-alpha 4. number of adverse events