RecruitingPhase 2NCT07234019

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

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


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

160 participants

Start Date

Jan 28, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Daratumumab(Anti-CD38 Monoclonal Antibody) and a drug called Rituximab for people with immune thrombocytopenia and treatment. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDaratumumab(Anti-CD38 Monoclonal Antibody)

All subjects were randomly assigned to group A (active comparator) and group B (experimental). For subjects in group B (experimental), rituximab (375mg/m2) was given once (day1) and Daratumumab (16mg/kg) was given four times (day8,15,22,29).

DRUGRituximab

All subjects were randomly assigned to group A (active comparator) and group B (experimental). For subjects in group A (active comparator) , rituximab (375mg/m2) was given once. For subjects in group B (experimental), rituximab (375mg/m2) was given once (day1) and anti-CD38 monoclonal antibody (16mg/kg) was given four times (day8,15,22,29).


Locations(1)

Chinese Academy of Medical Science and Blood Disease Hospital

Tianjin, Tianjin Municipality, China

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NCT07234019


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