Status:
COMPLETED
Investigating Intracellular and Plasma Imatinib Levels in Chronic Myeloid Leukemia
Lead Sponsor:
Brian Leber
Collaborating Sponsors:
University Health Network, Toronto
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to find out if the level of imatinib in the bloodstream, and the level that leukemia cells will predict how quickly your chronic myeloid leukemia improves with the treatme...
Detailed Description
The use of imatinib for the treatment of chronic myeloid leukemia has significantly improved the survival of most patients with this disease. This drug works by directly inhibiting the cancer-causing ...
Eligibility Criteria
Inclusion
- Patients must have a diagnosis of chronic myeloid leukemia in chronic phase (as defined in Appendix A) within four weeks of study registration based on bone marrow aspirate and peripheral blood counts. - Patients must have confirmation of the Philadelphia chromosome or variants by cytogenetics, or FISH, or positive test for bcr-abl by PCR. Patients with additional chromosomal abnormalities in addition to the Philadelphia chromosome are eligible.
- Age \>18 years.
- ECOG performance status \<2. (Appendix B)
- Patients must have normal organ function as defined below:
- Total Bilirubin \< 1.5 x Institutional Upper Limit of Normal (ULN)
- AST and/or ALT \< 2.5 x Institutional Upper Limit of Normal (ULN)
- Eligibility of patients receiving any medications or substances known to affect or determined following review of their case by the Principal Investigator.
Exclusion
- Patients may not be receiving any other investigational agents.
- Patients may not have received prior treatment with Imatinib.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or nursing women are excluded from this study because Imatinib has potential teratogenic effects and excretion in breast milk is unknown.
- No prior malignancies except for: adequately treated non-melanoma skin cancer, cervical carcinoma-in-situ, adequately treated Stage I or II cancer from which patient is in complete remission, or any other cancer from which patient has been disease free for 5 years.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00947830
Start Date
July 1 2009
End Date
April 1 2012
Last Update
January 11 2013
Active Locations (1)
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1
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2