Oral Nilotinib in Adults With Chronic Myeloid Leukemia (CML) in Blast Crisis Who Are Imatinib Resistant or Intolerant
- Conditions
- Chronic Myelogenous Leukemia
- Registration Number
- NCT00413270
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Novartis Investigative Site
🇨🇦Quebec, Canada