Thrombotic Thrombocytopenia Purpura
Conditions
Interventions
Trade Name: MabThera
Product Name: MabThera
Product Code: IDEC-C2B8, Ro 45-2294
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients >18 years and =65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -All female subjects who are knowingly pregnant or breast feeding or do not use an adequate form of contraception [the effects on the foetus and newborn have not yet been fully established so Rituximab should be avoided in these groups. Male patients receiving Rituximab should ensure adequate contraception for 12 months following treatment.] -Patients who are HIV positive [which does not appear to be antibody mediated, would be unlikely to benefit from Rituximab]. -Patients with childhood TTP. -Patients who have haemolytic uraemic syndrome [which is not associated with reduced ADAMTS 13 levels]. -Patients who are Post bone marrow transplant-either autologous or allogeneic -Patients with a medical or long term psychiatric condition which, in the opinion of the investigator, contraindicates the patients’ participation into the trial. -Previous or concurrent malignancies at other sites, with exception of appropriately treated localized epithelial or cervical cancer. Patients with a history of cured tumours may be entered (> 5 years).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: - Improved mortality of TTP patients (assessed at 3 months from presentation) - Safety and toxicity of Rituximab in conjunction with standard therapy for acute TTP - Effect of Rituximab on B lymphocyte function - Effect of Rituximab on ADAMTS 13 activity and antibody production and time to relapse ;Main Objective: Time to remission as defined by days until sustained platelet count>150 X 109/L, normal lactate dehydrogenase and number of plasma exchanges required, as defined by No of procedures per admission compared to historical controls.;Primary end point(s): Time to remission as defined by days until sustained platelet count>150 X 109/L, normal lactate dehydrogenase and number of plasma exchanges required. | — |
Countries
United Kingdom
Outcome results
None listed