hematologische aandoeningen B-cell related disorders
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) subjects with a clinical syndrome fulfilling the diagnostic criteria for pre-specified B-cell-related diseases; 2) disease severity requiring start of anti-CD20 or antibody targeted therapy and 3) adults or children above the age of 5 years.
Exclusion criteria
Exclusion criteria: 1) anti-CD20 treatment or thymectomy as part of clinical care, within the last 9 months ; 2) plasma exchange, plasmapheresis or immunoadsorption within the last 3 months ; 3) change in the dose of general immunosuppressive or oncological drugs, including azathioprine, mycophenolate mofetil, ciclosporin, tacrolimus within the last 3 months (change in dose of corticosteroids or intravenous immunoglobulin dose allowed); 4) anti-CD20 treatment or antibody depleting therapy as part of clinical trials as based on case-based peer review between researchers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be (changes in) titer of IgG antibodies, or if appropriate, titer of IgM antibodies. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will include: antibody characteristics, cellular and clinical parameters. | — |
Countries
Netherlands