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

NCT03851601 | Completed

• 1 other identifier: 9101
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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

Conditions

GVHD

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

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

ECP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 22, 2019
• Study Start: August 26, 2014
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: October 26, 2023

Record last verified: 2023-10

Locations

US (1)