Study of Rituximab in Patients With Steroid-Refractory Chronic Graft-Versus-Host Disease
- Sponsor
- The Korean Society of Hematopoietic Stem Cell Transplantation
- Study ID
- NCT00472225
- Phase
- PHASE2
- Status
- Unknown
Conditions
- Steroid-Refractory Chronic GVHD
Eligibility Criteria
- Sex
- ALL
- Age
- 3 Years - 74 Years
- Healthy Volunteers
- Not accepted
Interventions
- Rituximab — DRUGRituximab Induction: Rituximab 375 mg/m2 weekly IV for 4 consecutive weeks Rituximab Maintenance: Rituximab 375 mg/m2 monthly IV for 4 consecutive months
Study Details
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.
Key Dates
- Start date
- May 31, 2007
- Status verified
- Feb 2009
- Primary completion
- May 31, 2008
- Completion
- May 31, 2009
Study Design
- Enrollment
- 42 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: 1Rituximab treatment arm
Primary Outcome Measure
Complete response (CR) : Resolution of all signs and symptoms of chronic GVHD Partial response (PR) : Improvement (at least 1 clinical score reduction) in 1 or more organs of involvement and no evidence of worsening in any organ [ Time Frame: Response evaluation will be perfomed every 4 weeks during the maintenance of rituximab (the 12th, 16th, 20th, 24st, 36th and 52th week). ]