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

July 12, 2011 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada
        • Novartis Investigative Site
    • Alberta
      • Calgary, Alberta, Canada
        • Novartis Investigative Site
      • Edmonton, Alberta, Canada
        • Novartis Investigative Site
    • British Columbia
      • Burnaby, British Columbia, Canada
        • Novartis Investigative Site
      • Vancouver, British Columbia, Canada
        • Novartis Investigative Site
    • New Brunswick
      • Moncton, New Brunswick, Canada
        • Novartis Investigative Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada
        • Novartis Investigative Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Novartis Investigative Site
    • Ontario
      • 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
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada
        • Novartis Investigative Site
      • Sherbrooke, Quebec, Canada
        • Novartis Investigative Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Study Registration Dates

First Submitted

December 18, 2006

First Submitted That Met QC Criteria

December 18, 2006

First Posted (Estimate)

December 19, 2006

Study Record Updates

Last Update Posted (Estimate)

July 13, 2011

Last Update Submitted That Met QC Criteria

July 12, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAMN107ACA01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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