Clinical Trials Directory

Trials / Completed

CompletedNCT01233921

Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer

A Preliminary Study to Evaluate the Effects of Palifermin in Patients at Risk of Chronic Graft-versus-host Disease

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
6 (actual)
Sponsor
Martin, Paul · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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 description

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALpaliferminGiven IV
OTHERflow cytometryCorrelative studies
OTHERlaboratory biomarker analysisCorrelative studies
OTHERpharmacological studyCorrelative studies

Timeline

Start date
2010-09-01
Primary completion
2012-07-01
First posted
2010-11-03
Last updated
2014-04-02
Results posted
2014-04-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01233921. Inclusion in this directory is not an endorsement.