Blood Samples to Evaluate Biomarkers of Donor Chimerism

Sponsor
Fred Hutchinson Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00764829
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
80
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41
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Study Details

Study Description

Brief Summary

We are interested in patient-specific factors that may affect the balance of recipient cells and donor cells in patients who receive stem cell transplants. We will look at the way the patient's body breaks down two drugs, fludarabine and mycophenolate mofetil, and how these two drugs affect the patient's body.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Blood Samples to Evaluate Biomarkers of Donor Chimerism
    Study Start Date :
    Sep 1, 2008
    Actual Primary Completion Date :
    Feb 1, 2012
    Actual Study Completion Date :
    Feb 1, 2012

    Outcome Measures

    Primary Outcome Measures

    1. Donor T-cell chimerism [Day 28 post-transplant]

    Secondary Outcome Measures

    1. Exposure to fludarabine and mycophenolate mofetil and their breakdown products. [Before and after transplant]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Diagnosed with a hematologic disease or malignancy

    • Scheduled to receive nonablative conditioning with fludarabine and total body irradiation

    • Donor is well-matched by high resolution DNA techniques.

    • Scheduled to receive postgrafting immunosuppression of oral MMF (CellCept) and an oral calcineurin inhibitor.

    • Age >18 years at the time of enrollment.

    Exclusion criteria:

    -Diagnosed with an immunodeficiency disorder

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fred Hutchinson Cancer Research Center Seattle Washington United States 98109

    Sponsors and Collaborators

    • Fred Hutchinson Cancer Center
    • National Heart, Lung, and Blood Institute (NHLBI)

    Investigators

    • Principal Investigator: Jeannine S McCune, PharmD, Fred Hutchinson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00764829
    Other Study ID Numbers:
    • FHCRC - 1980.00
    • R01HL091744
    • IR-5957
    First Posted:
    Oct 2, 2008
    Last Update Posted:
    Feb 15, 2012
    Last Verified:
    Feb 1, 2012

    Study Results

    No Results Posted as of Feb 15, 2012