Phase II clinical trial of dasatinib in newly diagnosed chronic phase chronic myelogenous leukemia
Phase 2
- Conditions
- newly diagnosed chronic myelogenous leukemia in chronic phase
- Registration Number
- JPRN-UMIN000006346
- 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
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
Patients who are true with either of the followings are excluded; (1)A case with the double cancer of the activity. (2)Females during pregnancy or lactation. (3)Patients with no will or capability to use appropriate birth control during the trial. (4)Other serious past disease history or present concomitant diseases that are considered inappropriate to conduct this trial. (5)Past history of tyrosine kinase inhibitor therapy. (6)The patients of accelerated phase or blast phase clearly. (7)The patients with positive one of HBs antigen, HCV antibody, HIV antibodies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The ratio of patients who achieved major molecular response (MMR) after 12 months of Dasatinib therapy.
- Secondary Outcome Measures
Name Time Method (1) MMR rate at 6 months after the treatment. (2) CMR rate at 12 months after the treatment. (3) CCyR rate (4) The correlation of LGL expression and the MMR rate. (5) The correlation of LGL expression and onset of pleural effusion. (6) The examination of the optimal administration schedule. (7) The frequencies of adverse events Grade3 or more. (8) Event Free Survival(EFS) (9) Overall Survival (OS)