NCT00282503

Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Acute Graft Versus-Host Disease

A Randomized, Controlled, Parallel-Group, Multicenter Study of Extracorporeal Photoimmune Therapy With THERAKOS* UVADEX* for the Treatment of Patients With Newly Diagnosed Acute Graft Versus-Host Disease

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the safety and efficacy of ECP treatment combined with high dose corticosteroids versus high dose corticosteroids alone, in the treatment of patients with newly diagnosed acute GvHD (Grades II to III) that developed within 100 days following an allo HPCT.

Conditions

• Acute Graft-versus-Host Disease

Interventions

Type	Name	Description
DRUG	Methoxsalen+ECP, Methylprednisolone	Those patients randomized to the ECP Treatment arm will receive ECP treatments by the following regimen: * Weeks 1 through Week 3 - 3 times within each week. (Treatments do not have to be performed on consecutive days but should be completed within the 7-day period), * Weeks 4 through 12 - 2 times each week. (It is preferable that patients receive ECP treatments on consecutive days within a week, but there should never be \> 4 days between the ECP treatments within a week.) Methylprednisolone will be started at 2mg/kg daily dose and may be tapered by reducing dose each week at the following reductions: Daily Dose (mg/kg) 1 1.5 2 1.0 3 0.70 4 0.50 5 0.40 6 0.30 7 0.20 8 0.10
PROCEDURE	Ecp	ECP or Extra Corporeal Phototherapy will be used with UVADex

Timeline

• Start date: 2006-01-01
• Primary completion: 2007-06-01
• First posted: 2006-01-26
• Last updated: 2017-08-16

Locations

35 sites across 11 countries: United States, Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, Switzerland, United Kingdom