Status:
UNKNOWN
Dose Dense Rituximab for High Risk Newly Diagnosed Acute Immune Thrombocytopenic Purpura
Lead Sponsor:
New York Medical College
Conditions:
Immune Thrombocytopenic Purpura
Eligibility:
All Genders
1-21 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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 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
- Exclusion Criteria
- 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
- Female patients who are pregnant are ineligible (insert the reason: "due to risks of fetal and teratogenic adverse events as seen in animal/human studies" or "since there is yet no available information regarding human fetal or teratogenic toxicities").
- Lactating females are not eligible unless they have agreed not to breastfeed their infants.
- Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained.
Exclusion
Key Trial Info
Start Date :
February 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04323748
Start Date
February 24 2021
End Date
July 31 2025
Last Update
October 26 2023
Active Locations (1)
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1
New York Medical College
Valhalla, New York, United States, 10595