Immuno-regulatory Profiling of T Cells in GVHD Treated With Extracorporeal Photopheresis

Immuno-regulatory Profiling of T Cells in Patients With Graft Versus Host Disease Treated With Extracorporeal Photopheresis

Extracorporeal Photopheresis (ECP) has been used as one of the treatments for graft versus host disease (GVHD). Responses were observed in skin, liver, GI tract, mouth, eye and lung. ECP does not cause immune suppression and therefore less risk of infection or relapse of malignancy. However, the exact mechanism of action of this expensive procedure is not fully understood and no predictors of response to ECP are known so far. This reflects the need for a better understanding of GVHD and its response to ECP. Blood samples from 15 patients who receive ECP as part of the treatment of GVHD at our institution will be collected. Samples will be analyzed using flow cytometer

Study Overview

• Status: Completed
• Conditions: GVHD
• Intervention / Treatment: Other: blood samples

• Study Type: Observational
• Enrollment (Actual): 6

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients who are recipients of allogeneic stem cell grafts with the diagnosis of GVHD according to established criteria and physician decides to treat using ECP

Description

Inclusion Criteria:

1. Patients who are recipients of allogeneic stem cell grafts.
2. Patients with the diagnosis of GVHD according to established criteria and physician decides to treat using ECP
3. Patient must have 100% chimerism with the donor
4. No recent donor lymphocyte infusion.
5. Patients must be able to sustain a platelet count and a hematocrit > 20,000/mL and > 27% respectively, with or without transfusions.
6. The absolute WBC must be >1500/mL
7. Patient must be willing to comply with all study procedures.

Exclusion criteria:

1. Patients who are unable to tolerate the volume shifts associated with ECP treatment due to the presence of any of the following conditions: uncompensated congestive heart failure, pulmonary edema, severe asthma or chronic obstructive pulmonary disease, hepatorenal syndrome.
2. Active bleeding.
3. International normalized ration (INR) >2.
4. Patients with known hypersensitivity or allergy to psoralen.
5. Patients with known hypersensitivity or allergy to both citrate and heparin.
6. Patients with co-existing photosensitive disease (e.g. porphyria, systemic lupus erythematosus, albinism) or coagulation disorders.
7. Active, uncontrolled infection

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ECP; Blood samples from 15 patients who receive ECP as part of the treatment of GVHD at our institution will be collected. Samples will be analyzed using the flow cytometer	Other: blood samples; Blood samples from 15 patients who receive ECP as part of the treatment of GVHD at our institution will be collected. Samples will be analyzed using the flow cytometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effect of ECP on Tregs/TH17 ratio	investigate the effect of ECP on Tregs/TH17 ratio using flow-cytometry in patients with GVHD who receive treatment with ECP	6 months

Collaborators and Investigators

• Sponsor: Henry Ford Health System

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2014
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: February 20, 2019
• First Submitted That Met QC Criteria: February 20, 2019
• First Posted (Actual): February 22, 2019

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 9101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No