Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients.

Key Inclusion Criteria:

   - Newly diagnosed and untreated Ph+ CML CP or Ph+ CML CP or AP resistant or intolerant
   to either imatinib or dasatinib

   - Karnofsky ≥ 50% for patients > 10 years of age and Lansky ≥ 50 for patients ≤ 10 years
   of age

   - Adequate renal, hepatic and pancreatic function

   - Potassium, magnesium, phosphorus and total calcium values ≥ LLN (lower limit of
   normal)

   - Written informed consent

Key Exclusion Criteria:

   - Treatment with strong CYP3A4 inhibitors or inducers

   - Use or planned use of any medications that have a known risk or possible risk to
   prolong the QT interval

   - Acute or chronic liver, pancreatic or severe renal disease

   - History of pancreatitis or chronic pancreatitis.

   - Impaired cardiac function

   - No evidence of active graft vs host and <3mo since Stem Cell Transplant

   - Total body irradiation (TBI) or craniospinal radiation therapy <6months

   - Hypersensitivity to the active ingredient or any of the excipients including lactose.

   - the criteria regarding pregnancy and contraception

   - Active or systemic bacterial, fungal, or viral infection

   - known Hepatitis B, Hepatitis C, or HIV infection