- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00947830
Investigating Intracellular and Plasma Imatinib Levels in Chronic Myeloid Leukemia (OCT-1)
A Study Investigating the Predictive Value of Intracellular and Plasma Imatinib Levels in Newly Diagnosed Patients With Chronic Myeloid Leukemia
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 treatment.
1.1 Primary Objectives
To determine if intracellular levels of Imatinib in leukemic blood cells within two weeks of treatment initiation of patients with chronic myeloid leukemia in chronic phase predicts molecular and cytogenetic response at 6 and 12 months post treatment
1.2. Secondary Objectives
1.2.1 To determine if hOCT-1 mRNA levels at diagnosis predict Imatinib intracellular levels within two weeks of treatment initiation.
1.2.2 To determine the correlation between intracellular Imatinib levels at two weeks of treatment initiation with plasma Imatinib levels at two and four weeks after treatment initiation.
1.2.3 To determine if plasma Imatinib levels four weeks after treatment initiation correlate with plasma Imatinib levels 12 months after treatment initiation.
1.2.4 To determine if intracellular levels of Imatinib in leukemic blood cells within two weeks of treatment initiation correlate with intracellular levels of Imatinib in normal leukocytes 12 months after treatment initiation.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- Juravinski Cancer Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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To determine if intracellular levels of Imatinib in leukemic blood cells within two weeks of treatment initiation of patients with chronic myeloid leukemia in chronic phase predicts molecular and cytogenetic response at 6 and 12 months post treatment
Time Frame: One year after starting therapy for chronic myeloid leukemia
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One year after starting therapy for chronic myeloid leukemia
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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To determine if hOCT-1 mRNA levels at diagnosis predict Imatinib intracellular levels, OCT-1 levels at one year
Time Frame: One year after starting therapy for chronic myeloid leukemia
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One year after starting therapy for chronic myeloid leukemia
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Brian Leber, MDCM, Hamilton Health Sciences Corporation
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OCT-1
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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