Multicenter Phase II Clinical Study of the Safety and Efficacy of Discontinuing Nilotinib Treatment in Patients with Chronic Phase Chronic Myelogenous Leukemia Who Have Achieved Complete Molecular Response with Imatinib or Nilotinib
Phase 2
- Conditions
- Chronic Myelogenenous Leukemia
- Registration Number
- JPRN-UMIN000007141
- Lead Sponsor
- Cooperative study between the West Japan Hematology Study Group and the Clinical Research Support Center Kyushu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients previously treated by tyrosine kinase inhibitors other than imatinib or nilotinib. 2) Patients confirmed to have the T315I point mutation of BCR-ABL. 3) Patients with a history of hematopoietic stem cell transplantation. 4) Patients with cardiovascular dysfunction. 5) Pregnant women or those with suspected pregnancy. Nursing women and those who plan to become pregnant during the study period.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method