19
Participants
Start Date
January 31, 2006
Primary Completion Date
June 30, 2007
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"
Ecp
ECP or Extra Corporeal Phototherapy will be used with UVADex
Universite Catholique De Louvain, Brussels
Centre Hopitalier Universitaire Sart Tilman Liege, Liège
Royal Brisbane Women's Hospital, Brisbane
Weill Medical College of Cornell University, New York
San Martino Hospital, Genova
University of Rostock, Rostock
Thomas Jefferson University, Philadelphia
Universitatskrankenhaus Hamburg-Eppendorf, Hamburg
University of Florida, Gainesville
Universitats Hautklinik, Essen
University of Koln, Cologne
Leukemia and Bone Marrow Transplant Center - Avera Cancer Institute, Sioux Falls
University of Michigan Comprehensive Cancer Center, Ann Arbor
St. Louis Hospital, Paris
Ludwig-Maximillians-Universitat Munchen, München
Klinikum der Universitat Erlangen-Nurnberg, Erlangen
Stammzelltransplantationzentrum der Universitat Wurzbrug, Würzburg
Saint Vincent's Hospital, Darlinghurst
Westmead Hospital, Westmead
Medical University of Vienna, Vienna
University Hospital Gasthuisberg, Leuven
Vancouver General Hopsital, Vancouver
Princess Margaret Hospital, Toronto
Maisonneuve-Rosemont Hopital, Montreal
Royal Victoria Hospital, Montreal
Centre Hospitalier Universitaire Hospital Bordeaux, Bordeaux
University of Dresden, Dresden
Universitatsklinikum Leipzig, Leipzig
Universitat Regensburg, Regensburg
Universita di Siena Policlinico Le Scotte, Siena
Utrecht University Medical Center, Utrecht
Kantonsspital Basel, Basel
Hammersmith Hospital, London
Royal Victoria Infirmary, Newcastle
Rotheram General Hospital, Rotheram Yorkshire
Lead Sponsor
Collaborators (1)
PRA Health Sciences
INDUSTRY
Mallinckrodt
INDUSTRY