Clinical Trial: Oral Nilotinib in Adults With Chronic Myeloid Leukemia (CML) in Blast Crisis Who Are Imatinib Resistant or Intolerant
Study Status: No longer available
Recruit Status: No longer available
Study Type: Expanded Access
Official Title: 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
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 Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome:
Original Primary Outcome: Safety of nilotinib assessed by adverse events, vital signs, and physical exam
Current Secondary Outcome:
Original Secondary Outcome:
- Efficacy of nilotinib assessed by hematologic response, cytogenetic response and disease progression
- Percentage of patients with response to nilotinib over time
Information By: Novartis
Dates:
Date Received: December 18, 2006
Date Started: December 2006
Date Completion:
Last Updated: July 12, 2011
Last Verified: July 2011
