The purpose of this study is to assess the feasibility of a randomized, double blind, placebo controlled trial of add-on rituximab for non-splenectomized adults with acute immune thrombocytopenic purpura (ITP).
Immune thrombocytopenic purpura (ITP) is an autoimmune disease characterized by severe thrombocytopenia and bleeding. With current standard therapies, adult-onset ITP tends to recur thus exposing patients to prolonged risks of hemorrhage and toxicities of standard treatments. Rituximab, a chimeric anti-CD20 monoclonal antibody, has been shown to be effectively raise the platelet count in some patients with ITP and there is clinical and biological evidence to suggest that, if given early, rituximab may prevent ITP relapses. We have designed a randomized, double blind, placebo controlled pilot trial of rituximab for the treatment of non-splenectomized adults with acute ITP who are receiving standard treatments. The primary objectives of this trial are to determine the feasibility of recruitment, randomization and blinding; the safety of rituximab in ITP; and the event rate in the control group which will be used to calculate the sample size for a larger trial. Secondary objectives are to determine rates of 6-month event free survival where an event is defined as any of: a platelet count \<50; the need for rescue treatment; or significant bleeding. Data from this pilot trial will inform the design of a larger phase III trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
60
St. Paul's Hospital
Vancouver, British Columbia, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
McMaster Univerisity
Hamilton, Ontario, Canada
Grand River Regional Cancer Centre
Kitchener, Ontario, Canada
Feasibility of recruitment
Time frame: 3 years
Degree of adherence to the study protocol
Time frame: 3 years
Event free survival in controls
Time frame: 6 months
Bleeding
Time frame: 6 months
rescue therapy
Time frame: 6 months
Platelet count response
Time frame: 6 months
Quality of life
Time frame: 6 months
Circulating CD-20 positive lymphocytes
Time frame: 6 months
Platelet associated IgG
Time frame: 6 months
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London Health Sciences Centre
London, Ontario, Canada
Ottawa Health Research Institute
Ottawa, Ontario, Canada
University Health Network
Toronto, Ontario, Canada