chronic graft-versus-host disease, allogeneic stem cell transplantation, B-cell depletion
Conditions
Interventions
Treatment with rituximab (anti-CD20 monoclonal antibody) 375 mg/m2 i.v. for four weeks (weekly)
Monthly clinical report and physical examination
3 x skin biopsy
3 x Shirmer test
7 x 40ml blood
Sponsors
University Medical Centre Utrecht
P.O. Box 85500
3508 GA Utrecht, The Netherlands
Eligibility
Inclusion criteria
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. 3. Written informed consent 4. WHO performance status ¡Ü 2
Exclusion criteria
Exclusion criteria: 1. Relapse and a life expectancy of 2.5 x the upper normal value 6. Neutrophil count <1.5 x 109/l and hemoglobin level <6.2 mmol/l 7. Pregnant or lactating 8. Any experimental therapy within 30 days prior to randomization 9. Known sensitivity or allergy to murine products 10. Any other co-existing medical or psychological condition that will preclude participation in the study or compromise ability to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with a complete or partial response | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with a complete response Proportion of patients with a partial response Proportion of patients with an immune-histochemical improvement in skin biopsies Response duration Adverse events | — |
Contacts
Public ContactJ. Kuball
P.O. Box 85500
Outcome results
None listed