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Thymalin

Thymulin, Thymic Factor, Serum Thymic Factor, Facteur Thymique Serique

Quick Stats
Studies 202
Trials 37
Completed NA INTERVENTIONAL NCT01233921

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

View on ClinicalTrials.gov Updated Dec 15, 2025

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 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.

Interventions

Name: palifermin
Type: BIOLOGICAL
Description: Given IV
Name: flow cytometry
Type: OTHER
Description: Correlative studies
Name: laboratory biomarker analysis
Type: OTHER
Description: Correlative studies
Name: pharmacological study
Type: OTHER
Description: Correlative studies

Primary Outcomes

Measure: Changes in the Number of Recent Thymic Emigrants (RTE) Cluster of Differentiation (CD)4 T Cells in the Blood
TimeFrame: Baseline and 4 weeks after administration of palifermin
Description: 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.

Trial Information

NCT ID

NCT01233921

Status

Completed

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

Martin, Paul

Last Updated

December 15, 2025