Clinical Trial: Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Acute Graft Versus-Host Disease
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Randomized, Controlled, Parallel-Group, Multicenter Study of Extracorporeal Photoimmune Therapy With THERAKOS* UVADEX* for the Treatment of Patients With Newly Diagnosed Acute
Brief 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.
Detailed Summary:
Sponsor: Mallinckrodt
Current Primary Outcome: To compare the safety and efficacy of ECP treatment combined with high dose corticosteroids versus high dose corticosteroids alone, in patients with newly diagnosed acute GvHD (Grades II to III) that developed within 100 days following an allo HPCT. [ Time Frame: 8 weeks ]
Original Primary Outcome: To compare the safety and efficacy of ECP treatment combined with high dose corticosteroids versus high dose corticosteroids alone, in patients with newly diagnosed acute GvHD (Grades II to III) that developed within 100 days following an allo HPCT.
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Mallinckrodt
Dates:
Date Received: January 24, 2006
Date Started: January 2006
Date Completion:
Last Updated: October 18, 2016
Last Verified: October 2016