Status:
NO_LONGER_AVAILABLE
Oral Nilotinib in Adults With Chronic Myeloid Leukemia (CML) in Blast Crisis Who Are Imatinib Resistant or Intolerant
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Myelogenous Leukemia
Eligibility:
All Genders
18+ years
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. Pati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00413270
Start Date
December 1 2006
Last Update
July 13 2011
Active Locations (18)
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1
Novartis Investigative Site
Calgary, Alberta, Canada
2
Novartis Investigative Site
Edmonton, Alberta, Canada
3
Novartis Investigative Site
Burnaby, British Columbia, Canada
4
Novartis Investigative Site
Vancouver, British Columbia, Canada