Investigating Intracellular and Plasma Imatinib Levels in Chronic Myeloid Leukemia

NCT00947830 | Completed

• 1 other identifier: OCT-1
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chronic Myeloid Leukemia

Keywords

CML; intracellular imatinib level; OCT-1

Outcome Measures

Primary Outcomes (1)

• 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

  One year after starting therapy for chronic myeloid leukemia

Secondary Outcomes (1)

• To determine if hOCT-1 mRNA levels at diagnosis predict Imatinib intracellular levels, OCT-1 levels at one year

  One year after starting therapy for chronic myeloid leukemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

newly diagnosed patients with chronic myeloid leukemia in chronic phase

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brian Leber: lead
• University Health Network, Toronto: collaborator

Study Sites (1)

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood cells

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Brian Leber, MDCM

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: July 27, 2009
• First Posted: July 28, 2009
• Study Start: July 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: January 11, 2013

Record last verified: 2013-01

Locations

CA (1)