NCT04703621

The DART Study- Daratumumab Treatment in ITP

Daratumumab as a Treatment for Adult Immune Thrombocytopenia (The DART Study)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Ostfold Hospital Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• ITP

Interventions

Type	Name	Description
DRUG	Daratumumab Injection	subcutaneious daratumumab administration

Timeline

• Start date: 2021-01-21
• Primary completion: 2024-04-01
• Completion: 2024-12-01
• First posted: 2021-01-11
• Last updated: 2024-04-09

Locations

6 sites across 3 countries: Denmark, France, Norway