A Preliminary Study to Evaluate the Effects of Palifermin in Patients at Risk of Chronic Graft-versus-host Disease
I. To evaluate the pharmacodynamic effects of palifermin on thymic function in patients at
risk of chronic graft-vs-host disease (GVHD).
II. To evaluate the tolerability of palifermin in patients at risk of chronic GVHD.
OUTLINE: Patients are assigned to 1 of 2 groups based on whether they wish to receive
palifermin or not.
GROUP 1: Patients receive palifermin intravenously (IV) on days 1-3 in the absence of
GROUP 2: Patients do not receive palifermin.
After completion of study treatment, patients are followed up on days 7, 14, 21, and 28.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Changes in the number of recent thymic emigrants (RTE) cluster of differentiation (CD)4 T cells in the blood
RTE CD4 T cells will be defined according to co-expression of CD3, CD4, CD31, CD45RA, and CCR7.
At 4 weeks after administration of palifermin
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
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