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ANTI-CD20 THERAPY FOR THE TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE

Completed
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
Inclusion Criteria

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.

Exclusion Criteria

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
NameTimeMethod
Proportion of patients with a complete or partial response
Secondary Outcome Measures
NameTimeMethod
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
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