Biomarkers in Predicting Response in Patients With Graft-Versus-Host Disease Undergoing Extracorporeal Photophoresis

Graft Versus Host Disease (GVHD) Clinical Trial

Official title: T-regulatory Homing Subsets as a Predictor of Response in GVHD Treated With Extracorporeal Photopheresis

Status Terminated

Clinical Trial Summary

This clinical trial studies biomarkers in predicting response in patients with graft-versus-host disease (GVHD) undergoing extracorporeal photopheresis (ECP). ECP treats the patient's blood with ultraviolet light outside the body and kills the white blood cells before returning blood back into the patient's body. Studying samples of blood from patients with GVHD may help doctors identify and learn more about biomarkers related to GVHD.

Clinical Trial Description

PRIMARY OBJECTIVE:

I. To show that extracorporeal photopheresis (ECP)increases skin and gut homing T regulatory (T-reg) cells in patients with GVHD clinically responding to ECP.

SECONDARY OBJECTIVES:

I. Response rates of GVHD with extracorporeal photopheresis(ECP)as measured by NIH response criteria

II. Incidence of T-reg cell frequency(%)with various NIH subtypes of chronic graft-versus-host disease (GVHD)

III. Incidence of T-reg homing subsets(%)with various NIH subtypes of chronic graft-versus-host disease (GVHD)

OUTLINE:

Patients undergo ECP twice a week for 4 weeks and then twice a week every 2 weeks for 8 weeks.

After completion of study treatment, patients are followed up at 2, 4, and 6 months. ;

Related Conditions & MeSH terms

• Graft Versus Host Disease (GVHD)
• Graft vs Host Disease

• NCT number: NCT01324908
• Study type: Interventional
• Source: Vanderbilt-Ingram Cancer Center
• Status: Terminated
• Phase: N/A
• Start date: July 2011
• Completion date: November 16, 2020