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Recruiting Phase 2 NCT07063199

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

Trial Parameters

Condition Immune Thrombocytopenia
Sponsor Institute of Hematology & Blood Diseases Hospital, China
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 30
Sex ALL
Min Age 60 Years
Max Age N/A
Start Date 2025-08
Completion 2026-08
Interventions
Daratumumab Injection

Brief Summary

To evaluate the safety and efficacy of Anti-CD38 Antibody in the treatment of elderly patients with primary immune thrombocytopenia in patients who have failed multiple treatment.

Eligibility Criteria

Inclusion Criteria: * Age ≥60 years, male or female. * Before enrollment, the subjects have been clinically diagnosed with primary immune thrombocytopenia for no less than three months according to the American Society of Hematology guidelines 2011 Evidence-Based Practice Guideline (Neunert et al. 2011) or the International Consensus Report for the Investigation and Management of Primary Immune Thrombocytopenia (Provan et al. 2010), as applicable locally. * Patients have failed glucocorticoid therapy and at least one standard second-line therapy. (either due to inefficacy, efficacy could not be maintained, or relapse). Patients should have a history of response to previous ITP standard first-line therapy (glucocorticoids and/or intravenous human immunoglobulin) (PLT≥50×10\^9/L); * Platelet count \<30×10\^9/L within 24 hours before the first administration of the study drug; During the screening period, platelet counts were measured at least 2 times (at least 1 week apart), with an aver

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