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

• Status: No longer available
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Imatinib Mesylate

Criteria

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.