Rituximab Combining Bortezomib Versus Rituximab in Management of ITP

Status Not yet recruiting

Clinical Trial 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 .

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03443570
Study type	Interventional
Source	Shandong University
Contact	Ming Hou, Dr
Phone	+86-531-82169114
Email	houming@medmail.com.cn
Status	Not yet recruiting
Phase	Phase 3
Start date	March 1, 2018
Completion date	March 1, 2021

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02287649` - Polymorphism and Auto-reactive B and T Cells Subsets in Adult's Immune Thrombocytopenia (ITP)	N/A
Completed	`NCT02556814` - Caffeic Acid Combining High-dose Dexamethasone in Management of ITP	Phase 4
Terminated	`NCT02401061` - PRTX-100-202 Open-Label, Dose Escalation Study in Adult Patients With ITP	Phase 1/Phase 2
Completed	`NCT02868099` - Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Immune Thrombocytopenia (ITP)	Phase 3
Completed	`NCT02351622` - Caffeic Acid Tablets as a Second-line Therapy for ITP	Phase 3
Active, not recruiting	`NCT04741139` - Post IVIG Medication in Children With Immune Thrombocytopenia	Phase 1
Not yet recruiting	`NCT05494307` - The Combination of Terbutaline and Danazol as the Treatment of Corticosteroid-resistant/Relapse Immune Thrombocytopenia	Phase 2
Not yet recruiting	`NCT05468866` - The Expression of Immune Checkpoint CD28 rs1980422-related Single-nucleotide Polymorphisms in the Primary Immune Thrombocytopenia	N/A
Recruiting	`NCT04993885` - Avatrombopag in the Treatment of Adult Immune Thrombocytopenia With Autoantibodies	Phase 2
Recruiting	`NCT05281068` - The Combination of Iguratimod and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia	Phase 2
Not yet recruiting	`NCT05020288` - A Clinical Trial of the Orelabrutinib in the Management of Refractory ITP	Phase 2
Withdrawn	`NCT03965624` - Efficacy and Safety of Ixazomib and Dexamethasone Refractory Autoimmune Cytopenia	Phase 2
Not yet recruiting	`NCT03252457` - Decitabine Combining Dexamethasone Versus Dexamethasone in Management of ITP	Phase 3
Recruiting	`NCT05937828` - OBS'CEREVANCE: French Cohort of Pediatric Autoimmune Cytopenia
Completed	`NCT03156452` - Newly Diagnosed Immune Thrombocytopenia Testing the Standard Steroid Treatment Against Combined Steroid & Mycophenolate	Phase 3
Completed	`NCT03164915` - A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP)	Phase 3
Recruiting	`NCT02270801` - Recombinant Human Thrombopoietin (rhTPO) in Management of Immune Thrombocytopenia (ITP) in Pregnancy	Phase 3
Withdrawn	`NCT01976195` - High-dose Dexamethasone Combining Thalidomide Versus Dexamethasone Mono-therapy for Management of Newly-diagnosed ITP	Phase 2
Completed	`NCT01933035` - Extended Platelet Parameters as a Means to Differentiate Immune Thrombocytopenia From Hypo-proliferative Thrombocytopenias.	N/A
Recruiting	`NCT02821572` - Role of Fcgamma Receptors in Immune Thrombocytopenia (ITP)