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

Completed

• Conditions: GVHD
• Interventions: Other: blood samples

• Registration Number: NCT03851601
• Lead Sponsor: Henry Ford Health System

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-26
• Study First Submitted: 2019-02-20
• Study First Submitted QC: 2019-02-20
• Study First Posted: 2019-02-22
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ECP	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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States