A Phase III Study of Dasatinib vs. Imatinib in Patients With Newly Diagnosed Chronic Phase CM
Phase 3
Completed
- Registration Number
- CTRI/2007/091/000023
- Lead Sponsor
- The pharmaceutical company sponsoring this study is Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
�� Male & Female ≥18 years
�� CP Ph+ CML
�� ECOG PS 0-2
Exclusion Criteria
�� Pleural Effusion
�� Uncontrolled CV disease
�� Significant bleeding disorder unrelated to CML
�� Prior treatment with interferon/imatinib/dasatinib/anti-CML systemic treatments except anagrelide/hydroxyurea
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Best confirmed Complete Cytogenetic Response [Time Frame: at 12 months]Timepoint:
- Secondary Outcome Measures
Name Time Method Time in, duration and time to confirmed CCyR<br>&#56256;&#56442; Time in duration and time to confimred CCyR [Time Frame: within 12 months]Timepoint: