Overview

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.