Ostfold Hospital Trust is conducting a phase two multicenter clinical, open-label, (total) dose-escalating study with a safety run tacked on 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. Daratumumab is a human monoclonal antibody) that is received through a subcutaneous injection. This study aims to investigate the efficacy, the optimal number of treatments, and the safety daratumumab in steroid-refractory or steroid-dependent ITP patients who fail to respond to at least one previous second-line therapy, including rituximab and/ or TPO agonist. The first three patients enrolled will be included in the safety run-in phase. The next nine patients will be included in cohort one and will receive eight weekly injections. If the response rate is less than 100%, the next nine patients will be included in cohort two and will receive eight weekly injections followed by two bi-weekly injections. Eligibility includes adult ITP patients 18 years of age or older with a platelet count less than 30,000 µL. Participants must also have previously failed to achieve response to (or has relapsed after) corticosteroid therapy and at least one second-line therapy.
France, Norway, Denmark
https://www.clinicaltrials.gov/ct2/show/NCT04703621?recrs=a&cond=Immune+Thrombocytopenia&draw=2&rank=48
Recruiting
