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

GVHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03851601
• Other study ID #: 9101
• Status: Completed
• Start date: August 26, 2014
• Est. completion date: June 30, 2023

Study information

• Verified date: October 2023
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• GVHD

Intervention

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

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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