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