Journal article
A multicenter prospective phase 2 randomized study of extracorporeal photopheresis for treatment of chronic graft-versus-host disease
MED Flowers, JF Apperley, K Van Besien, A Elmaagacli, A Grigg, V Reddy, A Bacigalupo, HJ Kolb, L Bouzas, M Michallet, HM Prince, R Knobler, D Parenti, J Gallo, HT Greinix
Blood | AMER SOC HEMATOLOGY | Published : 2008
Abstract
Chronic graft-versus-host disease (cGVHD) is a major limitation of successful hematopoietic cell transplantation. The safety and efficacy of extracorporeal photopheresis (ECP) for 12 to 24 weeks together with standard therapy was compared with standard therapy alone in patients with cutaneous manifestations of cGVHD that could not be adequately controlled by corticosteroid treatment. The primary efficacy end point was a blinded quantitative comparison of percent change from baseline in Total Skin Score (TSS) of 10 body regions at week 12. Ninety-five patients were randomized to either ECP and standard therapy (n=48) or standard therapy alone (n=47). The median percentage improvement in TSS a..
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Funding Acknowledgements
The authors thank John D. Klein, PhD, and Mary M. Horowitz, MS, MD, for the conduct and interpretation of additional analyses for this manuscript. The authors are grateful to all patients who participated in this clinical trial.This work was supported by a grant from Therakos, Inc. (Exton, PA).