Comparing Daratumumab Versus Rituximab for Adults with Primary Immune Thrombocytopenia Not Responding to Glucocorticoids

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Daratumumab, an anti-CD38 monoclonal antibody, compared to rituximab in adults with primary immune thrombocytopenia ITP who have not responded to or relapsed after glucocorticoid treatment. ITP is an autoimmune disorder that causes low platelet counts leading to bleeding issues, and current treatments often have limited success, especially in recurrent or resistant cases. Participants will be randomly assigned to receive either rituximab once at a dose of 375 mgm2 or Daratumumab once weekly for eight weeks at 16 mgkg. This study is open-label and includes a Phase 2 design to assess and compare these treatments in patients who have previously failed glucocorticoid therapies. During the study, participants will undergo regular assessments including platelet counts, bleeding evaluations, and monitoring for adverse events at multiple timepoints up to 12 months. The primary outcome is the overall response rate at 12 weeks. Secondary outcomes include complete and partial response rates, platelet count thresholds, duration to response, emergency treatments, use of maintenance drugs, bleeding scale changes, and safety evaluations. The study will last up to one year following treatment initiation to closely monitor treatment effects and safety.

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