Blood Samples to Evaluate Biomarkers of Donor Chimerism

NCT ID: NCT00764829

Last Updated: 2012-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Leukemia Hodgkins Disease Non-hodgkins Lymphoma Myelodysplastic Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Fred Hutchinson Cancer Research Center

Principal Investigators

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Jeannine S McCune, PharmD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Locations

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Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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R01HL091744

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IR-5957

Identifier Type: OTHER

Identifier Source: secondary_id

FHCRC - 1980.00

Identifier Type: -

Identifier Source: org_study_id

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