ECP Therapy with UVADEX for the Treatment of Patients with cGvHD

• Research type

  Research Study

• Full title

  A Randomised Controlled Study of Extracorporeal Photopheresis (ECP) Therapy with UVADEXTM for the Treatment of Patients with Moderate to Severe Chronic Graft-versus Host Disease (cGvHD)

• IRAS ID

  64543

• Sponsor organisation

  THERAKOS Inc

• Eudract number

  2010-022780-35

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Chronic graft-versus-host disease (cGvHD) is one of many troublesome complications of allogeneic (taken from different individuals of the same species) haematopoietic (affecting the formation of blood or blood cells for example stem cells) cell transplantation. Symptoms may include dry eyes and dry mouth, hair loss, hepatitis (liver problems), lung and digestive tract disorders, skin rash and skin thickening.The development and origin of the disease and chain of events leading to the disease are not very well understood. Although the mild forms of the disease can be treated or managed with low dose immunosuppressant (drugs used to suppress the body's defence system) and steroids. Severe forms of cGvHD are more complicated and need serious medical supervision. Current common treatments include prednisone, cyclosporine, or tacrolimu (immunosuppressive drugs).Extracorporeal photopheresis (ECP) is a form of medical technology where blood is passed through a machine that separates a particular component of the blood and returns the remainder into the circulation system. ECP has been around for about 20 years and is used to treat a type of cancer called T-cell Lymphoma as well as a wide variety of other diseases that respond to immunosuppression, including GvHD, due to its good tolerability.Therakos is sponsoring this study to compare the safety and efficacy of ECP addition to a standard care in cGvHD patients. In this study, white blood cells will be separated and treated with a compound called 8-methyoxypsoralen, followed by exposure to Ultraviolet light and then returned to the body. 60 patients with moderate to severe cGvHD participating at about 40 centres will take part in the study. Patients will be randomly (like tossing a coin) assigned to one of two treatment groups.1. Standard drugs treatment (Corticosteroids, prednisone, or equivalent)2. Standard drugs treatment plus ECP

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  11/EM/0129

• Date of REC Opinion

  6 Jul 2011

• REC opinion

  Further Information Favourable Opinion