A phase 2 multicenter study evaluating the safety and efficacy of Nilotinib in patients with Imatinib-resistant/intolerant Ph+CML in chronic phase
Phase 2
- Conditions
- Chronic myelogenous leukemia
- Registration Number
- JPRN-UMIN000002007
- Lead Sponsor
- Shimousa Hematology Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients who have been treated with tyrosine kinase inhibitors (except for imatinib) prior to study entry. 2) Patients whose clone exhibit the T315I BCR-ABL mutation. 3) Patients who have any cardiac disturbances. 4) Patients who are: (a) pregnant, (b) breast feeding, (c) male or female of childbearing potential unwilling to use contraceptive precautions throughout the trial. 5) Severe medical conditions. 6) Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the rate of major molecular response at 12 months of nilotinib therapy.
- Secondary Outcome Measures
Name Time Method 1) To evaluate the response rates at 12 and 24 months of nilotinib therapy. 2) To evaluate the safety of nilotinib 3) To assess the progression-free survival (PFS), the event-free survival (EFS), and the overall survival (OS) at 3 years.