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Oral Nilotinib in Adults With Chronic Myeloid Leukemia (CML) in Blast Crisis Who Are Imatinib Resistant or Intolerant | Clinical Trials | Clareo Health

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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

NCT00413270•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (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

Key Dates

Start Date

December 1, 2006

Last Updated

July 13, 2011

Conditions

Chronic Myelogenous Leukemia

Interventions

nilotinib

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 13, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

Chart Review Study of Chronic Myelogenous Leukemia (CML) Patients Treated With Imatinib Outside of a Clinical Trial

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Dasatinib and Venetoclax in Treating Patients With Philadelphia Chromosome Positive or BCR-ABL1 Positive Early Chronic Phase Chronic Myelogenous Leukemia