A Pharmacokinetic (PK) Study of Nilotinib in Pediatric Patients With Philadelphia Chromosome-positive (Ph+) Chronic Myelogenous Leukemia (CML) or Acute Lymphoblastic Leukemia (ALL)

Inclusion Criteria:

- Must have one of the following: newly diagnosed CP Ph+CML, CP or AP resistant/
intolerant to imatinib and/or dasatinib, or Ph+ ALL either relapsed after or
refractory to standard therapy

- adequate renal, hepatic and pancreatic function

Exclusion Criteria:

- patients receiving therapy with strong CYP3A4 inhibitors and/or inducers and
treatments cannot be stopped or changed to a different medication at least 14 days
prior to starting study drug

- patients receiving therapy with any medications with a known risk or possible risk to
prolong the QT interval and the treatment cannot be either discontinued or switched
to a different medication prior to starting study drug.

- gastrointestinal impairment or disease that may interfere with drug absorption

- liver, pancreatic or severe renal disease unrelated to disease under study

- impaired cardiac function

- patients who received dasatinib within 3 days of starting study drug

- patients who received imatinib within 5 days of starting study drug

- patients receiving hydroxyurea or corticosteroids that has not been discontinued at
least 1 week after initiation of nilotinib

- patients who received hematopoietic growth factors within 7 days of starting study
drug or Pegfilgrastim (Neulasta®) within 14 days of starting study drug

- patients with Stem Cell Transplant (SCT) or Rescue without TBI: Evidence of active
graft vs. host disease and < 3 months since SCT

Other protocol-defined inclusion/exclusion criteria may apply