At a glance
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An Exploratory Trial to Assess the Improvement of Chronic Low-grade Non-hematologic Adverse Events Experienced by Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Treated With Imatinib When Switched to Nilotinib Treatment
In Brief
A Phase 4 clinical trial evaluating Nilotinib for Chronic Myelogenous Leukemia. Completed, enrolled 52 participants across 23 sites in 2 countries.
Detailed Summary
The purpose of this exploratory study will be to examine changes in chronic low grade chronic adverse events, measured by Common Terminology Criteria for Adverse Events (CTCAE) grading, when patients are switched from imatinib to nilotinib therapy.
Study Details
Timeline
Interventions
Participants received two 150 \[a total of 300 mg at each dosing\] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules \[a total of 400 mg at each dosing\] for patients enrolled prior to Protocol Amendment 1).