Study of Rituximab in Patients With Steroid-Refractory Chronic Graft-Versus-Host Disease

Overview

Chronic GVHD is the most common late complication following allogeneic stem cell transplantation. It has features resembling autoimmune disorders such as scleroderma, primary biliary cirrhosis, bronchiolitis obliterans, chronic immunodeficiency etc. Thus, chronic GVHD can lead to debilitating complications such as joint contractures, blindness, end-stage lung disease, etc so that chronic GVHD has a major impact both on survival as well as quality of life. Although its pathogenesis is still poorly unclear, it has been reported since 2000 that B cell-mediated immunity may also contribute to development of chronic GVHD other than T cells. Thus, targeting against B cell may be a useful treatment strategy in the treatment of chronic GVHD. The purpose of this study is to determine whether rituximab, an anti-CD20 monoclonal kimeric antibody is effective in the treatment of chronic graft-versus-host disease (chronic GVHD) refractory to steroid.

1. STUDY OBJECTIVES * Primary Endpoints: To assess the response rate * Secondary End points * To evaluate the discontinuation of corticosteroid * To assess the quality of life 2. Treatment schedule * The BSA on the date of every treatment cycle may be used as the same value of baseline BSA, if change of body weight is within 10% of baseline body weight. * Treatment schedule consists of induction and maintenance therapy as follows * Induction - Rituximab 375 mg/m2 weekly IV for 4 consecutive weeks * Maintenance - Rituximab 375 mg/m2 monthly IV for 4 consecutive months

Conditions