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
1 other identifier
expanded_access
N/A
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
18 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 18, 2006
CompletedFirst Posted
Study publicly available on registry
December 19, 2006
CompletedJuly 13, 2011
July 1, 2011
December 18, 2006
July 12, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Novartis Investigative Site
Calgary, Alberta, Canada
Novartis Investigative Site
Edmonton, Alberta, Canada
Novartis Investigative Site
Burnaby, British Columbia, Canada
Novartis Investigative Site
Vancouver, British Columbia, Canada
Novartis Investigative Site
Moncton, New Brunswick, Canada
Novartis Investigative Site
St. John's, Newfoundland and Labrador, Canada
Novartis Investigative Site
Halifax, Nova Scotia, Canada
Novartis Investigative Site
Brampton, Ontario, Canada
Novartis Investigative Site
Hamilton, Ontario, Canada
Novartis Investigative Site
London, Ontario, Canada
Novartis Investigative Site
Oshawa, Ontario, Canada
Novartis Investigative Site
Ottawa, Ontario, Canada
Novartis Investigative Site
Toronto, Ontario, q, Canada
Novartis Investigative Site
Windsor, Ontario, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Québec, Quebec, Canada
Novartis Investigative Site
Sherbrooke, Quebec, Canada
Novartis Investigative Site
Saskatoon, Saskatchewan, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 18, 2006
First Posted
December 19, 2006
Study Start
December 1, 2006
Last Updated
July 13, 2011
Record last verified: 2011-07