Oral Nilotinib in Adults With Chronic Myeloid Leukemia (CML) in Blast Crisis Who Are Imatinib Resistant or Intolerant

A Canadian Open-label, Multicenter, Expanded Access Study of Oral Nilotinib in Adult Patients With Imatinib-resistant or -Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase, or Chronic Phase

This study will evaluate the safety of nilotinib in adult patients with imatinib-resistant or -intolerant CML-blast crisis, CML-accelerated phase or CML-chronic phase when treated with nilotinib. Patients will be provided access to nilotinib until the drug is available on the market.

Inclusion Criteria:

• Imatinib resistant or intolerant Philadelphia chromosome positive CML in blast crisis
• Imatinib resistant or intolerant Philadelphia chromosome positive CML in accelerated phase
• Imatinib resistant or intolerant Philadelphia chromosome positive CML in chronic phase
• CML patients who have been treated with an investigational tyrosine kinase inhibitor who otherwise meet the definition of imatinib resistance or intolerance
• World Health Organization (WHO) performance status ≤ 2

Exclusion Criteria:

• Cytopathologically confirmed central nervous system (CNS) infiltration
• Impaired cardiac function
• Use of therapeutic coumarin derivatives
• Acute chronic liver or renal disease unrelated to tumor
• Other uncontrolled medical conditions
• Treatment with hematopoeitic colony stimulating factors
• Treatment with medications that have potential to prolong the QT interval
• Another malignancy currently clinically significant or requires active intervention

Other protocol-defined inclusion/exclusion criteria may apply.