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

  • STATUS
    Recruiting
  • End date
    Jul 31, 2024
  • participants needed
    20
  • sponsor
    New York Medical College
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Updated on 14 August 2021
See if I qualify
platelet count
rituximab
prednisone
KIT
kidney function tests
eltrombopag
romiplostim

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.

Details
Condition Autoimmune disease, IDIOPATHIC THROMBOCYTOPENIC PURPURA, Autoimmune Disease, Idiopathic Thrombocytopenic Purpura (ITP), Thrombocytopenic
Treatment Rituxan
Clinical Study IdentifierNCT04323748
SponsorNew York Medical College
Last Modified on14 August 2021

Eligibility

 Yes No Not Sure

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
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