Study of Nilotinib in Ph+ CML-CP Patients With Low Imatinib Trough Plasma Concentrations

Inclusion Criteria: * Cytogenetically confirmed Ph+ CML-CP Any prior dose of Imatinib * Imatinib 400 mg daily for ≥7 consecutive days prior to imatinib trough collection * Imatinib trough plasma concentration \<850 ng/mL Exclusion Criteria: * Prior documented failure events as defined by ELN guidelines: * Loss of CHR, CCyR, or clonal progression/Ph+ * Less than CHR at 3 months after diagnosis * No CyR at 6 months after diagnosis * Less than PCyR at 12 months after diagnosis * Less than CCyR at 18 months after diagnosis * Prior accelerated phase or blast phase CML * Previously documented T315I mutation * Previous treatment for CML with any other tyrosine kinase inhibitor except for imatinib * Patients who had any other treatment for CML (transplant) except interferon +/- ara- C, imatinib, hydroxyurea and/or anagrelide * Impaired cardiac function * Patients receiving therapy with strong inhibitors of CYP3A4 or medications that prolong the QT interval and cannot be either discontinued or switched to a different medication prior to starting study drug. * Any other malignancy that is clinically significant or requires active intervention. * Major surgery within 4 weeks prior to Day 1 of study or who have not recovered from prior surgery * Treatment with other investigational agents within 30 days of Day 1 * Women who are pregnant, breast feeding, or of childbearing potential without a negative serum test at baseline. Post-menopausal women must be amenorrhoeic for at least 12 mo…