NCT03443570

Rituximab Combining Bortezomib Versus Rituximab in Management of ITP

A Multicenter Prospective Randomized Study of Rituximab Combined With Bortezomib Versus Rituximab in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The project was undertaking by Qilu Hospital of Shandong University and other 2 well-known hospitals in China. In order to report the efficacy and safety of rituximab combining with bortezomib for the treatment of adults with immune thrombocytopenia (ITP), compared to rituximab alone .

Detailed description

The investigators anticipate to undertaking a parallel group, multicentre, randomised controlled trial of 100 ITP adult patients from 3 medical centers in China. One part of the participants are randomly selected to receive rituximab (given with a fixed dose of 500 mg administered as an intravenous infusion every two weeks, for 2 times totally) combining with bortezomib (given subcutaneous injection at a fixed dose of 2.0 mg weekly, for 4 times totally), the others are selected to receive rituximab alone (given with a fixed dose of 500 mg administered as an intravenous infusion every two weeks, for 2 times totally). Platelet count, bleeding and other symptoms were evaluated before and after treatment, adverse events are also recorded throughout the study in order to report the efficacy and safety of the combination therapy compared to rituximab alone therapy for the treatment of adults with ITP.

Conditions

• Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic

Interventions

Type	Name	Description
DRUG	Rituximab	given with a fixed dose of 500 mg administered as an intravenous infusion every two weeks, for 2 times totally
DRUG	Bortezomib	given subcutaneous injection at a fixed dose of 2.0 mg weekly, for 4 times totally

Timeline

• Start date: 2018-03-01
• Primary completion: 2020-03-01
• Completion: 2021-03-01
• First posted: 2018-02-23
• Last updated: 2018-02-23

Locations

1 site across 1 country: China