Immuno-regulatory Profiling of T Cells in GVHD 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

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Key information

Conditions

GVHD

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.
Active bleeding.
International normalized ration (INR) >2.
Patients with known hypersensitivity or allergy to psoralen.
Patients with known hypersensitivity or allergy to both citrate and heparin.
Patients with co-existing photosensitive disease (e.g. porphyria, systemic lupus erythematosus, albinism) or coagulation disorders.
Active, uncontrolled infection

Treatment and study plan

Blood Samples

Other

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

Primary outcomes

effect of ECP on Tregs/TH17 ratio

Time frame: 6 months

investigate the effect of ECP on Tregs/TH17 ratio using flow-cytometry in patients with GVHD who receive treatment with ECP

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2023
Study completion: 2023
First posted: Feb 22, 2019
Registry last updated: Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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