NCT04323748 Dose Dense Rituximab for High Risk Newly Diagnosed Acute Immune Thrombocytopenic Purpura
| NCT ID | NCT04323748 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | New York Medical College |
| Condition | Immune Thrombocytopenic Purpura |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2021-02-24 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2021-02-24 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. Correlative studies will be performed as outlined in the appendices. Quality of Life will be measured using the KIT as outlined in the protocol.
Eligibility Criteria
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.
Contact & Investigator
Edo Scahefer, MD
PRINCIPAL INVESTIGATOR
New York Medical College
Frequently Asked Questions
Who can join the NCT04323748 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 21 Years, studying Immune Thrombocytopenic Purpura. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04323748 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04323748 currently recruiting?
Yes, NCT04323748 is actively recruiting participants. Contact the research team at erin_morris@nymc.edu for enrollment information.
Where is the NCT04323748 trial being conducted?
This trial is being conducted at Vahalla, United States.
Who is sponsoring the NCT04323748 clinical trial?
NCT04323748 is sponsored by New York Medical College. The principal investigator is Edo Scahefer, MD at New York Medical College. The trial plans to enroll 20 participants.