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Clinical Trials/NCT01141959
NCT01141959
Completed
Not Applicable

Blood Samples to Identify Biomarkers in Haploidentical Graft Recipients

Fred Hutchinson Cancer Center1 site in 1 country11 target enrollmentMay 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Leukemia
Sponsor
Fred Hutchinson Cancer Center
Enrollment
11
Locations
1
Primary Endpoint
Donor T-cell chimerism
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The investigators are interested in identifying patient-specific factors related to donor chimerism in patients who receive nonmyeloablative hematopoietic stem cell transplants from haploidentical donors. We will look how patients' bodies break down and immediately respond to cyclophosphamide, fludarabine and mycophenolate mofetil.

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
December 2011
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Scheduled to receive nonmyeloablative conditioning which includes fludarabine
  • Scheduled to receive a haploidentical graft
  • Scheduled to receive postgrafting immunosuppression which includes oral mycophenolate mofetil (MMF) or enteric-coated mycophenolic acid
  • Age \>18 years at the time of enrollment

Exclusion Criteria

  • Diagnosed with an immunodeficiency disorder, including HIV

Outcomes

Primary Outcomes

Donor T-cell chimerism

Time Frame: Day 28 post-transplant

Secondary Outcomes

  • Exposure to cyclophosphamide, fludarabine, and mycophenolate mofetil and their breakdown products(1 week before through 3 weeks after transplant)

Study Sites (1)

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