Phase II clinial trial of Dasatinib for Imatinib resistant or refractory chronic myeloid leukemia in chronic phase.
Phase 2
- Conditions
- Chronic myeloid leukemia patients in chronic phase who are refractory or resistant to Imatinib therapy.
- Registration Number
- JPRN-UMIN000002779
- Lead Sponsor
- Ph Leukemia Trial Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
Not provided
Exclusion Criteria
Patients who are true with either of the followings are excluded; @Females in childbearing years with no will or capability to use appropriate birth control during the trial. @Females during pregnancy or lactation. @Male patients with no will or capability to use appropriate birth control during the trial. @Past history or concomitant cardiovascular diseases that are serious or poorly-controlled. @Other serious past disease history or present concomitant diseases that are considered inappropriate to condcut this trial. @Active infectious diseases, or Other malignancies, or HBV/HIV infection. @Pasthistory of Dasatinib therapy.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The ratio of patients who achieved complete cytogenetic response (CCyR) after 12 months of Dasatinib therapy.
- Secondary Outcome Measures
Name Time Method