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

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.

Study Overview

• Status: Terminated
• Conditions: Graft Versus Host Disease (GVHD)
• Intervention / Treatment: Other: laboratory biomarker analysis; Procedure: extracorporeal photopheresis

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.

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Dana Farber Cancer Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232-6838
      • Vanderbilt-Ingram Cancer Center
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University, Massey Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with any NIH subtype of chronic GVHD that is being treated with ECP
• Karnofsky Performance Scale (KPS) > 60% at time of study enrollment
• Life expectancy > 3 months
• Steroid dose not greater than 2 mg/kg prednisone equivalent at time of study enrollment
• If patient has steroid refractory GVHD (defined as worsening of GVHD after 3 days of 2 mg/kg prednisone equivalent or no improvement after 7 days of 2 mg/kg prednisone equivalent), time interval from start of steroids to initiation of ECP should not be > 14 days
• No use of an investigational agent within 2 weeks of starting ECP
• No uncontrolled bacterial, fungal or viral disease (therapy for cytomegalovirus [CMV] viremia is permitted)
• No evidence of relapse or progression of underlying disease (molecular evidence of relapse/progression or mixed chimerism is permitted)
• Women of childbearing potential (WOCBP) should be willing to use 2 forms of contraception; male patients should be willing to use contraception
• Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care

Exclusion Criteria:

• Female patients who are breastfeeding or pregnant
• Patients known to be human immunodeficiency virus (HIV) positive
• Bronchiolitis obliterans as the sole indication of ECP
• Serious medical or psychiatric illness likely to interfere with participation in this clinical study
• Mechanical ventilation, renal replacement therapy, admitted in intensive care until at time of enrollment
• Stage 4 gastrointestinal GVHD as per Seattle-Glucksberg criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment (Treg predictor of response to ECP); Patients undergo ECP twice a week for 4 weeks and then twice a week every 2 weeks for 8 weeks.	Other: laboratory biomarker analysis; Correlative studies; Procedure: extracorporeal photopheresis; Undergo ECP; Other Names: extracorporeal photophoresis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Response rates of GVHD with ECP as measured by NIH response criteria	at 6 months
Incidence of T-reg cell frequency (%) with various NIH subtypes of chronic GVHD	at 6 months
Incidence of T-reg homing subsets (%) with various NIH subtypes of chronic GVHD	at 6 months

Collaborators and Investigators

• Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Madan Jagasia, Vanderbilt-Ingram Cancer Center

Publications and helpful links

Helpful Links

• Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): July 28, 2017
• Study Completion (Actual): November 16, 2020

Study Registration Dates

• First Submitted: March 7, 2011
• First Submitted That Met QC Criteria: March 26, 2011
• First Posted (Estimate): March 29, 2011

Study Record Updates

• Last Update Posted (Actual): January 14, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease
• Other Study ID Numbers: VICC CTT 1063; NCI-2011-00225 (Registry Identifier: CTRP (Clinical Trial Reporting Program))