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.
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.
Age ≥ 10 years
Grade II-IV bleeding at diagnosis
Patients with a history of Grade III-IV allergic reaction to rituximab
Patients with bone marrow neoplastic infiltration
Patients with a history of hepatitis B infection
Pregnancy and Breast Feeding
Single group
rituxan
DrugThe 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
To determine the safety events: Number of participants with treatment-related Grade III or higher adverse events as assessed by CTCAE v5.0.
To determine the occurrence of any Grade ≥ 3 non hematologic toxicity (per CTCAE v.5) which is possibly, probably, or definitely related to rituximab.
To determine the Response Rate
To quantify remission rates for high-risk patients with acute ITP treated with a dose dense administration of rituximab.
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