Clinical Trial: Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Preliminary Study to Evaluate the Effects of Palifermin in Patients at Risk of Chronic Graft-versus-host Disease
Brief Summary:
RATIONALE: Growth factors, such as palifermin, may prevent chronic graft-versus-host disease caused by donor stem cell transplant.
PURPOSE: This randomized clinical trial studies palifermin in preventing chronic graft-versus-host disease in patients who have undergone donor stem cell transplant for hematologic cancer
Detailed Summary:
OBJECTIVES:
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 unacceptable toxicity.
GROUP 2: Patients do not receive palifermin.
After completion of study treatment, patients are followed up on days 7, 14, 21, and 28.
Sponsor: Martin, Paul
Current Primary Outcome: Changes in the Number of Recent Thymic Emigrants (RTE) Cluster of Differentiation (CD)4 T Cells in the Blood [ Time Frame: Baseline and 4 weeks after administration of palifermin ]
Original Primary Outcome:
- Changes in the number of RTE CD4 T cells in the blood [ Time Frame: At 4 weeks after administration of palifermin ]
- Changes in the number of naive CD4 T cells in the blood [ Time Frame: At 4 weeks after administration of palifermin ]
- Changes in the proportion and numbers of TREC-positive CD4 T cells in the blood [ Time Frame: At 4 weeks after administration of palifermin ]
Current Secondary Outcome: Changes in the Number of Naive CD4 T Cells in the Blood [ Time Frame: Baseline and 4 weeks after administration of palifermin ]
Original Secondary Outcome:
Information By: Fred Hutchinson Cancer Research Center
Dates:
Date Received: November 2, 2010
Date Started: September 2010
Date Completion:
Last Updated: February 19, 2014
Last Verified: February 2014