30 patients with a steroid refractory cGVHD will be treated with anti-B-cell therapy
Conditions
Interventions
Treatment with Rituximab once a week, for 4 weeks.
Sponsors
Roche Nederland B.V.
Eligibility
Inclusion criteria
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
Exclusion criteria: 1. Relapse with a life expectancy of < 6 months; 3. Severe infections.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Proportion of patients with a histological response. | — |
Contacts
Public ContactEllen Meijer
University Medical Center Utrecht, Department of Hematology/H03.102, P.O. Box 85500
Outcome results
None listed