High dose Rituximab for newly diagnosed acute immune thrombocytopenic purpura

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of a dose dense administration of Rituximab in treating patients with newly diagnosed acute immune thrombocytopenic purpura (ITP). It will assess the relapse rate following this treatment and include correlative studies as outlined in the protocol. Additionally, the quality of life of participants will be measured using the KIT assessment tool. The study focuses on high-risk patients to determine if this approach can improve outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• New York Medical College
  Vahalla, New York, United States Recruiting

Study contacts

• Principal investigator: Edo Scahefer, MD — New York Medical College
• Study coordinator: Erin Morris, RN
• Email: erin_morris@nymc.edu
• Phone: 714-964-5359

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.