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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00413270
Recruitment Status : No longer available
First Posted : December 19, 2006
Last Update Posted : July 13, 2011
Information provided by:

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.

Condition or disease Intervention/treatment
Chronic Myelogenous Leukemia Drug: nilotinib

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, Accelerated Phase, or Chronic Phase
Study Start Date : December 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00413270

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
Novartis Investigative Site
Quebec, Canada
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00413270     History of Changes
Other Study ID Numbers: CAMN107ACA01
First Posted: December 19, 2006    Key Record Dates
Last Update Posted: July 13, 2011
Last Verified: July 2011

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

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