Donor Statin Treatment for Prevention of Severe Acute GVHD After Myeloablative Hematopoietic Cell Transplantation
I. To assess whether 2 weeks of donor statin treatment reduces the risk of severe acute
I. To assess whether 2 weeks of statin treatment of normal PBSC donors is feasible,
tolerable and safe.
Donors receive atorvastatin orally (PO) beginning on day -14 and continuing until the last
day of stem cell collection.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Grade 3-4 acute GVHD
A reduction in the cumulative incidence of acute GVHD from 15% to < 5% would represent a reasonable goal after hematopoietic cell transplant (HCT) with filgrastim (G-CSF)-mobilized blood cells and constitute study success.
First 100 days after transplant
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
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