TRIAL OF RITUXIMAB FOR CHRONIC, SEVERE IDIOPATHIC THROMBOCYTOPENIC PURPURA

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This trial will test the hypothesis that Ritusimab will extend the remission period for subjects with refractory pediatric ITP. Primary 1. Efficacy:To evaluate the effectiveness of rituximab in severe or refractory pediatric ITP, with response defined as follows: platelet count 50,000/mL on four measures spanning 28 days starting at 9 - 12 weeks (day 57 - day 84) (i.e., once established during the 9 - 12 week timeframe, the response would be defined as beginning at the first one of these measures). All measurements must be independent of supportive care, as follows: 1) no IVIG administration within 7 days of the first measure or at any time between measures, 2) no initiation of a 4-day corticosteroid pulse within 7 days of the first measure or at any time between measures, and 3) no platelet transfusions administered within 7 days of the first measure or at any time between measures.