NCT04323748

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

The Use of Dose Dense Rituximab for High Risk Patients With Newly Diagnosed Acute Immune Thrombocytopenic Purpura

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: New York Medical College · Academic / Other
• Sex: All
• Age: 1 Year – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Immune Thrombocytopenic Purpura

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-02-24
• Primary completion: 2026-07-31
• Completion: 2027-07-31
• First posted: 2020-03-26
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study