Phase II Study of Rituximab and Daratumumab Combination for Adults with Primary Immune Thrombocytopenia Not Responding to Previous Treatments

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining Daratumumab, an anti-CD38 monoclonal antibody, with Rituximab in adults with primary immune thrombocytopenia ITP who did not respond to or relapsed after glucocorticoid treatment. ITP is an autoimmune condition causing low platelet counts and bleeding, with current treatments often inadequate for many patients. This phase II, open-label study focuses on patients with relapsed or refractory ITP, aiming to offer new treatment options by targeting both B cells and long-lived plasma cells involved in disease resistance. Participants receive one dose of Rituximab 375 mgm2 on day 1, followed by eight doses of Daratumumab 16 mgkg on days 8, 15, 22, 29, 36, 43, 50, and 57. The combination is intended to reduce harmful antibodies by removing different immune cells. This single-arm trial involves no placebo group and monitors patients over a treatment period to assess response and safety. During the study, participants will be regularly assessed for their platelet counts and bleeding symptoms. The primary outcome is the overall response rate at 12 weeks, with secondary measures including platelet levels, time to reach specific platelet thresholds, bleeding severity, need for rescue treatments, and adverse events monitored over one year. Patients adherence to treatment and safety will be carefully tracked throughout the trial, which is expected to last until March 2027.

Anti-CD38 Monoclonal Antibody Combined With Rituximab in the Management of Primary Immune Thrombocytopenia (ITP)