Dose Dense Rituximab Treatment for High-Risk Children and Young Adults with Newly Diagnosed Acute Immune Thrombocytopenic Purpura

What this Trial Is About

Researchers are evaluating a dose dense administration of Rituximab in patients aged 1 to 21 years with newly diagnosed acute immune thrombocytopenic purpura ITP who are considered high risk. The study aims to determine the safety and relapse rate following this specific dosing schedule, with additional correlative studies and quality of life assessments using the KIT questionnaire. Participants will receive five doses of Rituximab at 375 mgm2 each. The doses are given on Days 0, 2, 7 2 days, 14 2 days, and 21 2 days. This study does not include a comparison group all enrolled patients will receive this dose dense Rituximab regimen. During the study, researchers will monitor for treatment-related Grade III or higher adverse events over one year and evaluate the response rate. The study involves clinical assessments, laboratory tests including bone marrow biopsy to confirm diagnosis, and performance status evaluations. Quality of life will also be measured, with safety and treatment effects followed closely throughout the year-long observation period.

Dose Dense Rituximab for High Risk Newly Diagnosed Acute Immune Thrombocytopenic Purpura