Discontinuation of Dasatinib in Patients With Chronic Myeloid Leukemia-CP Who Have Maintained Complete Molecular Remission for Two Years; Dasatinib Stop Trial
- Registration Number
- NCT01627132
- Lead Sponsor
- Shimousa Hematology Study Group
- Brief Summary
The purpose of this study is to assess whether dasatinib can be discontinued without occurrence of molecular relapse in patients with chronic myeloid leukemia in chronic phase in complete molecular remission (CMR) while on dasatinib.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- Chronic Myeloid Leukemia in the Chronic Phase.
- Patients with BCR-ABL-negative checks.
- 15 years old over.
- ECOG performance status (PS) score 0-2.
- Adequate organ function (hepatic, renal and lung).
- Signed written informed consent.
Exclusion Criteria
- A case with the double cancer of the activity.
- Women who are pregnant or breastfeeding.
- Patients with complications or a history of severe.
- Patients with mutation of T315I、F317L、V299L.
- Patients with additional chromosome abnormalities.
- The case of Pleural effusion with poor control.
- Patients with a history of hematopoietic stem cell transplantation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description dasatinib Dasatinib -
- Primary Outcome Measures
Name Time Method The overall probability of maintenance of complete molecular remission at 12 months after stopping dasatinib. at 12 months
- Secondary Outcome Measures
Name Time Method Rate of complete molecular remission that will be sustained after dasatinib rechallenge. at 12 months
Trial Locations
- Locations (1)
Nippon Medical School
🇯🇵Sendagi 1-1-5, Bunkyo-ku,Tokyo, Japan