ANTI-CD20 THERAPY FOR THE TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE
- Conditions
- chronic graft-versus-host disease, allogeneic stem cell transplantation, B-cell depletion
- Registration Number
- NL-OMON27822
- Lead Sponsor
- niversity Medical Centre UtrechtP.O. Box 855003508 GA Utrecht, The Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1. Age > = 18 years
2. Chronic GVHD, including skin localization, refractory or dependent to first line treatment consisting of steroids and/or ciclosporine. Refractory cGVHD is defined as progressive cGVHD after at least 2 weeks of first line treatment or no response after 4 weeks of first line treatment.. Dependent cGVHD is defined as an inability to taper immunosuppressive treatment.
1. Relapse and a life expectancy of < 6 months
2. Life expectancy of < 6 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with a complete or partial response
- Secondary Outcome Measures
Name Time Method Proportion of patients with a complete response <br /><br>Proportion of patients with a partial response <br /><br>Proportion of patients with an immune-histochemical improvement in skin biopsies<br>Response duration <br /><br>Adverse events
Related Research Topics
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