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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04323748
Other study ID # 14124
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date February 24, 2021
Est. completion date July 31, 2025

Study information

Verified date October 2023
Source New York Medical College
Contact Erin Morris, RN
Phone 714-964-5359
Email erin_morris@nymc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date July 31, 2025
Est. primary completion date July 31, 2024
Accepts healthy volunteers No
Gender All
Age group 1 Year to 21 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
rituxan
The dose dense administration of rituximab will consist of 5 doses total Days: 0, 2, 7 (± 2 days), 14 (± 2 days), and 21 (± 2 days); Dose: 375 mg/m2

Locations

Country Name City State
United States New York Medical College Valhalla New York

Sponsors (1)

Lead Sponsor Collaborator
New York Medical College

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To determine the safety events: Number of participants with treatment-related Grade III or higher adverse events as assessed by CTCAE v5.0. To determine the occurrence of any Grade = 3 non hematologic toxicity (per CTCAE v.5) which is possibly, probably, or definitely related to rituximab. 1 year
Primary To determine the Response Rate To quantify remission rates for high-risk patients with acute ITP treated with a dose dense administration of rituximab. 1 year
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