Safety and Effectiveness Study of Daratumumab in Treating Elderly Patients with Primary Immune Thrombocytopenia Who Have Tried Multiple Treatments

What this Trial Is About

Researchers are evaluating the safety and effectiveness of an Anti-CD38 antibody called Daratumumab in treating elderly patients aged 60 and above who have primary immune thrombocytopenia ITP and have not responded well to multiple treatments. ITP is an autoimmune disease causing low platelet counts, leading to bleeding issues, and it is especially challenging to treat in older adults who may not tolerate standard therapies well. This Phase 2, single-arm, open-label study aims to address these treatment challenges by targeting long-lived plasma cells believed to contribute to the diseases persistence. The study involves 30 elderly participants receiving Daratumumab infusions once a week at a dose of 16 mgkg over four weeks. This initial treatment period is followed by a 20-week observation phase without treatment to monitor ongoing safety and effectiveness. Daratumumab works by targeting CD38 on plasma cells, aiming to reduce the abnormal antibodies that cause platelet destruction in ITP. The trial evaluates both immediate and longer-term responses to this therapy. Participants will undergo regular monitoring including platelet counts measured multiple times before treatment and throughout the 24-week study. Safety is closely observed, tracking adverse events and bleeding episodes. Researchers will assess treatment effectiveness within 8 weeks and at intervals up to 24 weeks, including remission rates and the need for emergency treatments. The study also monitors the reduction of other ITP medications and overall patient health during and after treatment.

Anti-CD38 Antibody Treating Elderly Patients With Primary Immune Thrombocytopenia (ITP)