Anti-CD20 therapy for the treatment ofchronic graft versus host disease.
- Conditions
- 30 patients with a steroid refractory cGVHD will be treated with anti-B-cell therapy
- Registration Number
- NL-OMON27646
- Lead Sponsor
- Roche Nederland B.V.
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
1. Age > 18 yr;
2. Steroid refractory chronic GVHD, including skin localization;
3. No other treatment apart from steroids and when applicable standard GVHD prevention.
Exclusion Criteria
1. Relapse with a life expectancy of < 6 months;
3. Severe infections.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of complete and partial responses. A complete response will be defined as a complete resolution of clinical evidence of chronic GVHD. A partial response will be defined by an improvement in any of the affected organs.
- Secondary Outcome Measures
Name Time Method Proportion of patients with a histological response.