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Clinical Trials/NCT00764829
NCT00764829
Completed
Not Applicable

Blood Samples to Evaluate Biomarkers of Donor Chimerism

Fred Hutchinson Cancer Center1 site in 1 country80 target enrollmentSeptember 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Leukemia
Sponsor
Fred Hutchinson Cancer Center
Enrollment
80
Locations
1
Primary Endpoint
Donor T-cell chimerism
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2008
End Date
February 2012
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Donor T-cell chimerism

Time Frame: Day 28 post-transplant

Secondary Outcomes

  • Exposure to fludarabine and mycophenolate mofetil and their breakdown products.(Before and after transplant)

Study Sites (1)

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