ITP Clinical Trial - The DART Study- Daratumumab Treatment in ITP

Status Active, not recruiting

Clinical Trial Summary

A multicenter clinical, open-label total dose-escalating phase II study with safety run-in to explore the clinical activity, total dosage, and safety of daratumumab in adult ITP patients who have not responded adequately or relapsed after corticosteroids and at least one second-line therapy including rituximab and/or TPO-RA.

Clinical Trial Description

Many patients with chronic ITP require repeated or continuous medications to maintain a safe platelet count. B-cell depletion with rituximab in ITP induces the differentiation of short-lived auto-immune plasma cells into pathogenic long-lived plasma cells in the spleen that was not present before treatment. It has been reported that refractory ITP is related to the presence of long-lived plasma cells, which are resistant to steroids and immunosuppressants, including rituximab. These findings lead to the hypothesis that therapy directed against plasma cells may help overcome treatment resistance. At least in a proportion of patients, treatment resistance is caused by CD20 negative long-lived plasma cells. This study aims to investigate the efficacy, the optimal number of treatments, and safety of anti-CD38 antibody daratumumab steroid-refractory or steroid-dependent in ITP patients who fail to respond to at least one previous second-line therapy, including rituximab and/ or TPO agonist. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04703621
Study type	Interventional
Source	Ostfold Hospital Trust
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	January 21, 2021
Completion date	December 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05281068` - The Combination of Iguratimod and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia	Phase 2
Recruiting	`NCT05635266` - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Completed	`NCT02914054` - Therapy of Adults Affected by Idiopathic Thrombocytopenic Purpura With Dexamethasone	Phase 2/Phase 3
Recruiting	`NCT05116423` - Machine-learning Based Prediction Model in Primary Immune Thrombocytopenia
Terminated	`NCT04904276` - Observational Study of Fostamatinib as Second Line Therapy in Adult Patients With Immune Thrombocytopenia (ITP) and Insufficient Response to a Prior Therapy
Recruiting	`NCT04747080` - The Combination of Tacrolimus and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia	Phase 2
Not yet recruiting	`NCT04482777` - IL37,Tlymphocytes,NK Cells in Pathogenesis of ITP
Recruiting	`NCT05446831` - Baricitinib for Steroid-resistant/Relapse Immune Thrombocytopenia	Phase 2
Recruiting	`NCT05118126` - Gut Microbiota in ITP
Recruiting	`NCT05315778` - Anti-BCMA CAR T-Cell Therapy for R/R ITP	Phase 2
Active, not recruiting	`NCT04943042` - An Observational, Multicenter Study to Evaluate the Use and Effectiveness of Doptelet® in Patients With ITP
Completed	`NCT04089267` - Evaluating the Efficacy and Safety of Different Human Thrombopoietin (rhTPO) Regimens in the Treatment of Patients With Primary Immune Thrombocytopenia (ITP)	Phase 4
Recruiting	`NCT04735588` - Investigation on the Incidence and Course of COVID-19 in Patients With Prior, Ongoing or de Novo ITP. Evaluation of the Impact of COVID-19 Pandemic on the Management of ITP