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

Inclusion Criteria:

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

- Karnofsky or Lansky ≥ 50

- Adequate renal, hepatic and pancreatic function

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

- Written informed consent

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.