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A Randomized, Open-label Study To Compare The Efficacy And Safety Of Rituximab Combining Anti-CD38 Monoclonal Antibody Versus Rituximab in ITP Patients Who Failed or Relapsed After Glucocorticoid Therapy
This randomized, open-label study aim to compare the efficacy and safety of rituximab combining anti-CD38 monoclonal antibody with rituximab in ITP patients.This study will be conducted in ITP patients who had not responded to or had relapsed after previous glucocorticoid treatment.
Details
| Lead sponsor | Institute of Hematology & Blood Diseases Hospital, China |
|---|---|
| Phase | Phase 2 |
| Status | RECRUITING |
| Enrolment | 160 |
| Start date | 2026-01-28 |
| Completion | 2028-11 |
Conditions
- Immune Thrombocytopenia
- Treatment
Interventions
- Daratumumab（Anti-CD38 Monoclonal Antibody）
- Rituximab
Primary outcomes
- Overall response rate at week 12 — 12 weeks
Overall response rate was defined as proportion of subjects with a platelet count ≥ 30 × 10\^9/L and at least twice the baseline platelet count without bleeding and subjects with a platelet count ≥ 100 × 10\^9/L without bleeding at week 12 after initial administration in absence of rescue therapy, and without having had dose increment of TPO-RA or corticosteroids during the study period.
Countries
China