NCT01554514

Low Dose Rituximab in Thrombotic Thrombocytopenic Purpura

Adjuvant Low Dose Rituximab for Acquired TTP With Severe ADAMTS13 Deficiency

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Thrombotic thrombocytopenic purpura (TTP) is a disease characterized by small blood clots throughout the body that can damage major organs and cause death. TTP is treated with plasma exchange (also called "plasmapheresis"). Patients who do not respond initially to plasma exchange often are helped by later treatment with rituximab. The purpose of this study is to see whether combining low doses of rituximab with plasma exchange will help patients get better sooner and reduce the chance of getting TTP again.

Detailed description

This is a pilot safety/efficacy study of adjuvant low dose rituximab (100 mg/week x 4 doses) plus standard plasma exchange and corticosteroids for the treatment of thrombotic thrombocytopenic purpura (TTP) with severe ADAMTS13 deficiency. Results for study subjects will be compared to historical controls treated initially with plasma exchange and corticosteroids. This study proposes to test the hypothesis that adjuvant low dose rituximab may decrease the incidence of a composite primary endpoint (exacerbations or refractory disease) in acquired TTP with severe ADAMTS13 deficiency. A novel ADAMTS13 assay will be used to identify patients with TTP and severe ADAMTS13 deficiency for enrollment, and to assess the utility of ADAMST13 as a biomarker for response to therapy and prognosis.

Conditions

• Thrombotic Thrombocytopenic Purpura

Interventions

Type	Name	Description
BIOLOGICAL	rituximab	rituximab intravenously 100 mg every week for four doses

Timeline

• Start date: 2012-08-01
• Primary completion: 2020-02-14
• Completion: 2020-02-14
• First posted: 2012-03-15
• Last updated: 2021-08-17
• Results posted: 2021-08-13

Locations

4 sites across 1 country: United States