DAsatinib DIscontinuation for 1st-Line treatment with Chronic Myelogenous Leukemia-Chronic Phase with One Year Complete Molecular Remissio
Phase 2
Recruiting
- Conditions
- chronic myeloid leukemia
- Registration Number
- JPRN-UMIN000011099
- Lead Sponsor
- 1st DADI/IMIDAS4th -Trial Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
1.Patients who have been treated by TKI except Dasatinib or Interferon.(except patients who have treated by Imatinib within 4 weeks as an ex-treatment.) 2. Concurrent malignancy other than CML 3.Women who are pregnant or breastfeeding 4.A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Molecular relapse free survival rate after discontinuation of dastinib at 6 months.
- Secondary Outcome Measures
Name Time Method Molecular relapse free survival rate after discontinuation of dastinib at 12 months. We assessed LGL expansions, dose of dasatinib and time to CMR, total dose of dasatinib in last 12 months during CMR, metods and, sex and sokal risk group as potential prognostic factors for molecular relapse free survival. Molecular remission rate after dasatinib re-challenge in cases of molecular relapse.