Phase II Study of Safety and Efficacy. Dasatinib in Patients with Chronic Phase Chronic Myelogenous Leukemia achieving a Major Molecular Response on Imatinib.
Phase 2
- Conditions
- Chronic phase chronic myelogenous leukemia
- Registration Number
- JPRN-UMIN000007413
- Lead Sponsor
- CML stem cell study group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
1)Active double cancer 2)Pregnant or breastfeeding woman 3)Patient who has clear pleural effusion 4)Patient who have the anamnesis or complications of a cardiovascular disorder with serious or poor control. -myocardial infarction within 6 months -angina pectoris within 3 months -congestive heart failure within 3 months -congenital long QT syndrome
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The cumulative CMR rate by 18 months after dasatinib treatment
- Secondary Outcome Measures
Name Time Method *Cumulative CMR rate by 12 months and 24 months after the initiation of dasatinib treatment *Dose intensity in 12 months, a large granular lymphocyte: LGL incidence * Relevance of progression free survival: PFS, safety, Sokal score, and OS, PFS and EFS.