T-regulatory Homing Subsets as a Predictor of Response in GVHD Treated With Extracorporeal Photopheresis
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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Association of frequency of skin and gut homing Tregs (%) in patients with chronic GVHD with response to ECP.
6 months after last patient is on study
No
Madan Jagasia
Principal Investigator
Vanderbilt-Ingram Cancer Center
United States: Federal Government
VICC BMT 1063
NCT01324908
July 2011
September 2017
Name | Location |
---|---|
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
Emory University | Atlanta, Georgia 30322 |
Dana Farber Cancer Center | Boston, Massachusetts 02115 |
Virginia Commonwealth University, Massey Cancer Center | Richmond, Virginia 23298 |