Study of Nilotinib as First Line Treatment in Philadelphia Chromosome Positive(Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

Exclusion Criteria

• •Treatment with tyrosine kinase inhibitor(s) prior to study (in emergent cases where the patient requires disease management while awaiting study start, commercial supplies of imatinib at any dose may be prescribed to the patient but for no longer than 31 days in duration)
• •Known cytopathologically confirmed Central Nervous System CNS infiltration
• •Impaired cardiac function
• •Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection)
• •Acute or chronic liver, pancreatic or severe renal disease considered unrelated to disease
• •Patients with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention
• •History of significant congenital or acquired bleeding disorder unrelated to cancer
• •Previous radiotherapy to ≥25% of the bone marrow
• •Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or gastric bypass surgery)
• •Use of therapeutic coumarin derivatives (i.e. warfarin, acenocoumarol, phenprocoumon)
• •Patients actively receiving therapy with strong Cytochrome P450 3A4 isoenzyme (CYP3A4) inhibitors (e.g, erythromycin, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, mibefradil)
• •Patients actively receiving therapy with medications that have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug