Status:
UNKNOWN
Study of Rituximab in Patients With Steroid-Refractory Chronic Graft-Versus-Host Disease
Lead Sponsor:
The Korean Society of Hematopoietic Stem Cell Transplantation
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Steroid-Refractory Chronic GVHD
Eligibility:
All Genders
3-74 years
Phase:
PHASE2
Brief Summary
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, bronch...
Detailed Description
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. Tre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2009
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00472225
Start Date
May 1 2007
End Date
May 1 2009
Last Update
February 24 2009
Active Locations (9)
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1
Kyungpook University Hospital
Daegu, Kyungsang-do, South Korea
2
Busan Baik Hospital
Busan, South Korea
3
Busan National University Hospital
Busan, South Korea
4
Chun Nam National University Hospital
Gwangju, South Korea