Blood Samples to Evaluate Biomarkers of Donor Chimerism

Completed

• Conditions: Leukemia; Hodgkins Disease; Myelodysplastic Syndrome; Non-hodgkins Lymphoma

• Registration Number: NCT00764829
• Lead Sponsor: Fred Hutchinson Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-30
• Study First Submitted QC: 2008-09-30
• Study First Posted: 2008-10-02
• Status Verified: 2012-02
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Last Update Submitted: 2012-02-13
• Last Update Posted: 2012-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Donor T-cell chimerism	Day 28 post-transplant

Secondary Outcome Measures

Name	Time	Method
Exposure to fludarabine and mycophenolate mofetil and their breakdown products.	Before and after transplant

Trial Locations

Locations (1)

Fred Hutchinson Cancer Research Center; 🇺🇸 Seattle, Washington, United States