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Oral Nilotinib in Adults With Chronic Myeloid Leukemia (CML) in Blast Crisis Who Are Imatinib Resistant or Intolerant

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00413270
First received: December 18, 2006
Last updated: July 12, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Myelogenous Leukemia
 Drug: nilotinib
 Phase 3

Study Type: Expanded Access     What is 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, Accelerated Phase, or Chronic Phase

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Study Start Date: December 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00413270

Locations
Canada, Alberta
Novartis Investigative Site
Calgary, Alberta, Canada
Novartis Investigative Site
Edmonton, Alberta, Canada
Canada, British Columbia
Novartis Investigative Site
Burnaby, British Columbia, Canada
Novartis Investigative Site
Vancouver, British Columbia, Canada
Canada, New Brunswick
Novartis Investigative Site
Moncton, New Brunswick, Canada
Canada, Newfoundland and Labrador
Novartis Investigative Site
St. John's, Newfoundland and Labrador, Canada
Canada, Nova Scotia
Novartis Investigative Site
Halifax, Nova Scotia, Canada
Canada, Ontario
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, Canada, q
Novartis Investigative Site
Windsor, Ontario, Canada
Canada, Quebec
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Sherbrooke, Quebec, Canada
Canada, Saskatchewan
Novartis Investigative Site
Saskatoon, Saskatchewan, Canada
Canada
Novartis Investigative Site
Quebec, Canada
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00413270     History of Changes
Other Study ID Numbers: CAMN107ACA01
Study First Received: December 18, 2006
Last Updated: July 12, 2011
Health Authority: Canada: Health Canada

Keywords provided by Novartis:
Imatinib resistant,
Imatinib intolerant,
CML- blast crisis,
CML- Accelerated phase,
CML- chronic phase,
 nilotinib,
Chronic myelogenous leukemia,
blast crisis,
accelerated phase,
chronic phase

Additional relevant MeSH terms:
Blast Crisis
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Cell Transformation, Neoplastic
Neoplastic Processes
Myeloproliferative Disorders
Bone Marrow Diseases
 Hematologic Diseases
Pathologic Processes
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013