A Randomized Controlled Study of Extracorporeal Photopheresis (ECP) Therapy with UVADEX™ for the Treatment of Patients with Moderate to Severe Chronic Graft versus Host Disease (cGVHD)
Study Status
Open to Enrollment
Study Description
Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient’s body.
The purpose of this study is to determine how well a treatment called extracorporeal photopheresis (ECP) therapy, in addition to standard therapy, works in treating moderate to severe chronic Graft-versus-Host Disease (cGVHD), compared to standard drug treatment alone.
In ECP therapy, blood is collected from a patient. The patient’s blood cells are then treated with an experimental drug called UVADEX. After the blood cells have absorbed the drug, the blood cells are treated with ultraviolet light and injected back into the patient’s body. ECP therapy has been used for about 20 years as an approved therapy for cutaneous T-cell lymphoma.
The standard drug treatment consists of corticosteroids and an immunosuppressant cyclosporine or tacrolimus.
Study participants will be randomly assigned to one of two treatment arms:
- Arm 1: standard drug therapy plus ECP
- Arm 2: standard drug therapy alone
Study participation will last about 28 weeks.
Disease Status and/or Stage
Moderate to Severe Graft-versus-Host Disease (GVHD)
Sponsor
Therakos
Key Eligibility
- Men and women age 18 and older
- Moderate to severe Graft-versus-Host disease (GVHD) with onset within 2 years of transplantation
- Prior ECP for acute GVHD is allowed
- Detailed eligibility reviewed when you contact the study team
Principal Investigator
Contact
- June Greenberg, RN
- (212) 746-2651
- [email protected]
- Bone Marrow Transplant Medical Practice
- (212) 746-2119
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Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]
