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 ]

RTE CD4 T cells will be defined according to co-expression of CD3, CD4, CD31, CD45RA, and CCR7. Cells will be counted by flow cytometry at baseline and at 4 weeks and changes will be measured as cells per microliter of blood. Positive results indicate an increase in the number of cells between baseline and 4 weeks. Negative results indicate a decrease in the number of cells between baseline and 4 weeks.


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 ]

Naive CD4 T cells will be defined according to co-expression of CD3, CD4, CD45RA, and CCR7. Positive results indicate an increase in the number of cells between baseline and 4 weeks. Negative results indicate a decrease in the number of cells between baseline and 4 weeks.


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