Steroid-Refractory Chronic GVHD Clinical Trial
Official title:
Open-Labelled, Multicenter Phase II Study of Rituximab in Patients With Steroid-Refractory Chronic Graft-Versus-Host Disease
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.
| Status | Active, not recruiting |
| Enrollment | 42 |
| Est. completion date | May 2009 |
| Est. primary completion date | May 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 3 Years to 74 Years |
| Eligibility |
Inclusion Criteria: - All recipients underwent allogeneic stem cell transplantation for haematologic disorders - All recipients diagnosed as chronic GVHD according to diagnostic criteria proposed by National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic GVHD - The presence of one diagnostic sign Or - The presence of one distinctive sign (Appendix 1B) with laboratory or histopathologic confirmation in the same or other organ if diagnostic feature is not present - All patients with chronic GVHD have at least moderate score based on the global scoring system of chronic GVHD - Recipients refractory or resistant to therapy with corticosteroid - Patients had chronic GVHD with the same severity during the last one month while they had received the equivalent of prednisone =0.5mg/kg per day or 1mg/kg every other day at least for 30 days or longer - Informed consent - Other concomitant medication - Patients treated with other immunosuppressive agents (cyclosporine, thalidomide etc) as a combination therapy with corticosteroid must be receiving a dosage that has been stable for at least 1 month prior to screening. Exclusion Criteria: - Recipients received donor lymphocyte infusions in the preceding 100 days - Serious comorbid diseases - Life expectancy of less than 1 month - Age < 2 years and > 75 years - Pregnant or intended to become pregnant - Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Busan Baik Hospital | Busan | |
| Korea, Republic of | Busan National University Hospital | Busan | |
| Korea, Republic of | Kyungpook University Hospital | Daegu | Kyungsang-do |
| Korea, Republic of | Chun Nam National University Hospital | Gwangju | |
| Korea, Republic of | Samsung Medical Center | Seoul | |
| Korea, Republic of | Seoul National University | Seoul | |
| Korea, Republic of | Soon Chun Hyang Hospital | Seoul | |
| Korea, Republic of | The Catholic University of Korea | Seoul | |
| Korea, Republic of | Yonsei University Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| The Korean Society of Hematopoietic Stem Cell Transplantation | Hoffmann-La Roche |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Response evaluation will be perfomed every 4 weeks during the maintenance of rituximab (the 12th, 16th, 20th, 24st, 36th and 52th week). | No | |
| Secondary | Steroid tapering | Within one year after start the first dose of rituximab | No | |
| Secondary | Quality of life | Baseline, the 8th and 52th week. | No | |
| Secondary | Toxicity | 1 year | Yes |