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 months to be considered of non-childbearing potential. Women of childbearing potential must have a negative serum pregnancy test within 7 days of the first dose of nilotinib
* Sexually active male and female patients taking nilotinib unwilling to use adequate contraception throughout the trial and 3 months following discontinuation of study drug