Status:
COMPLETED
Immuno-regulatory Profiling of T Cells in GVHD Treated With Extracorporeal Photopheresis
Lead Sponsor:
Henry Ford Health System
Conditions:
GVHD
Eligibility:
All Genders
18-75 years
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 caus...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 26 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03851601
Start Date
August 26 2014
End Date
June 30 2023
Last Update
October 26 2023
Active Locations (1)
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1
Henry Ford Hospital
Detroit, Michigan, United States, 48202