Daratumumab Versus Rituximab in the Management of Pediatric Primary Immune Thrombocytopenia (ITP)

Recruiting Phase 2 Interventional Study
Immune Thrombocytopenia Treatment
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
6 – 18
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
122 (estimated)
Sponsor
Institute of Hematology & Blood Diseases Hospital, China · Other
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About This Trial

This randomized, open-label study aim to compare the efficacy and safety of Daratumumab (anti-CD38 monoclonal antibody) with Rituximab in pediatric ITP patients.This study will be conducted in pediatric ITP patients who had not responded to or had relapsed after previous glucocorticoid treatment.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age ≥6,\<18 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 …
Contacts

Lei Zhang, MD

+8613502118379

zhanglei1@ihcams.ac.cn

CONTACT

Ting Sun, MD

+8615822339131

sunting@ihcams.ac.cn

CONTACT