NCT01324908

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Graft Versus Host Disease (GVHD)

Interventions

Type	Name	Description
PROCEDURE	extracorporeal photopheresis	Undergo ECP
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2011-07-01
• Primary completion: 2017-07-28
• Completion: 2020-11-16
• First posted: 2011-03-29
• Last updated: 2021-01-14

Locations

4 sites across 1 country: United States