Nilotinib in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
NCT00905593 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS
Last updated 2012-07-18
Summary
Multi-center, open-label, non-randomized trial to evaluate long-term safety and efficacy of nilotinib. Approximately 20 patients will be enrolled in this trial at 3 centers in Mexico, which means all ongoing patients participating on \[CAMN107A2109\] excluding discontinued patients. During this study, patients will receive nilotinib orally, at a dose of 400 mg b.i.d. Patients will normally receive nilotinib on an outpatient basis. This trial will have a maximum of 24 months of follow-up time.
Conditions
- Chronic Myeloid Leukemia
Interventions
- DRUG
-
Nilotinib
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-09-30
- Primary Completion
- 2011-04-30
Countries
- Mexico
Study Locations
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