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

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT07362238
Phase
PHASE2
Status
Recruiting
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Conditions

  • Immune Thrombocytopenia
  • Treatment

Eligibility Criteria

Sex
ALL
Age
6 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    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.
  • Daratumumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Mar 31, 2026
Status verified
Jan 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
122 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Rituximab
    Rituximab (375mg/m2) was given once.
  • Experimental: Daratumumab（Anti-CD38 Monoclonal Antibody ）
    Daratumumab（anti-CD38 monoclonal antibody ）(16mg/kg) was given once a week for eight times

Primary Outcome Measure

Overall response rate at week 12 [ Time Frame: 12 weeks ]

Central Contacts

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