Clinical study evaluating efficacy of Nilotinib in CML patients
Phase 2
Recruiting
- Conditions
- Chronic myelogenous leukemia
- Registration Number
- JPRN-UMIN000002579
- Lead Sponsor
- ara Hospital Kinki University School Of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients suspected in accelerated phase(AP) or in blast crisis(BC). 2) Confirmed the expression of T315I mutation at genetic screening. 3) Previously treated with any other agents or therapy for CML, other than Hydroxyurea, Interferon-alfa, and Imatinib. 4) History of a invasive double cancer within 5 years before. 5) Presence of serious or uncontrolled concomitant disease. 6) Pregnancy or possibility of pregnancy positive. 7) Women with lactation status or patients who have willing of pregnancy. 8) Patients suffering mental disorder or psychotic symptom.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the efficacy of twice daily administration of Nilotinib at a dose of 400 mg in Ph chromosome-positive (Ph+) CML patients with Imatinib resistance or intolerance based on the rate of major molecular response at 12 months after starting treatment.
- Secondary Outcome Measures
Name Time Method