The Use of Dose Dense Rituximab for High Risk Patients With Newly Diagnosed Acute Immune Thrombocytopenic Purpura
New York Medical College
Summary
The purpose of this study is to determine if a dose dense administration of Rituximab in newly diagnosed acute immune thrombocytopenic purpura (ITP) and determine relapse rate following this treatment. Correlative studies will be performed as outlined in the appendices. Quality of Life will be measured using the KIT as outlined in the protocol.
Eligibility
- Age range
- 1–21 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age: Subjects must be ≥ 1 year and ≤ 21 years of age. * Diagnosis: Patients must have newly diagnosed ITP and a platelet count of ≤ 20 x 109 per Liter. Bone marrow aspirate and biopsy should be performed to rule out malignancy in the bone marrow. * High-risk features : In addition, patients must have one of more of the following high-risk criteria: * Age ≥ 10 years * Grade II-IV bleeding at diagnosis * ANA positivity * No history of preceding infection within 2 weeks prior to ITP diagnosis * Performance Status: Patients must have a performance status ≥ 50%. Use…
Interventions
- Drugrituxan
The dose dense administration of rituximab will consist of 5 doses total Days: 0, 2, 7 (± 2 days), 14 (± 2 days), and 21 (± 2 days); Dose: 375 mg/m2
Location
- New York Medical CollegeVahalla, New York