The Use of Dose Dense Rituximab for High Risk Patients With Newly Diagnosed Acute Immune Thrombocytopenic Purpura
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.
• 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 Karnofsky for patients \> 16 years of age and Lansky for patients less than or equal to 16 years of age. See Appendix I for performance score.
• Prior Therapy
‣ Patients may not have received any treatment for ITP prior to start of therapy.
⁃ Patients may not receive systemic steroids ≥ 0.5 mg/kg prednisone (or equivalent) within 2 weeks prior to diagnosis.
• Concomitant Medications Restrictions:
‣ Steroids are only warranted as premedication prior to rituximab.
⁃ Patients who receive thrombopoetic agonists, eltrombopag or romiplostim will be taken off protocol.
• Organ Function Requirements
‣ Adequate Renal Function Defined As: estimated CrCl \> 60 mL/min or \>30% of GFR for age based on the Schwartz formula
⁃ Adequate Liver Function Defined As: AST and/or ALT less than 5 times the upper limit of normal, and/or direct bilirubin less than the 2 times of the upper limit of normal