Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07362238
PHASE2

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

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

Summary

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.

Official title: A Randomized, Open-label Study To Compare The Efficacy And Safety Of Daratumumab Versus Rituximab in ITP Patients Who Failed or Relapsed After Glucocorticoid Therapy

Key Details

Gender

All

Age Range

6 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

122

Start Date

2026-03

Completion Date

2028-03

Last Updated

2026-01-23

Healthy Volunteers

No

Interventions

DRUG

Rituximab

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.

DRUG

Daratumumab

All subjects were randomly assigned to group A (active comparator) and group B (experimental). For subjects in group B (experimental), Daratumumab (anti-CD38 monoclonal antibody ) (16mg/kg) was given once a week for eight times.

Locations (1)

Chinese Academy of Medical Science and Blood Disease Hospital

Tianjin, China