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Target to B! - Towards patient-tailored immunotherapy to effectively treat B-cell associated disease

Target to B! - Towards patient-tailored immunotherapy to effectively treat B-cell associated disease - T2B!

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON49992
Enrollment
2000
Registered
2020-03-31
Start date
2020-09-28
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hematologische aandoeningen B-cell related disorders

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
2 Years to 99 Years

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

MeasureTime frame
The primary outcome will be (changes in) titer of IgG antibodies, or if appropriate, titer of IgM antibodies.

Secondary

MeasureTime frame
Secondary outcomes will include: antibody characteristics, cellular and clinical parameters.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)