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

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT07234019
Phase
PHASE2
Status
Recruiting
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Conditions

  • Immune Thrombocytopenia
  • Treatment

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab（Anti-CD38 Monoclonal Antibody） — DRUG
    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).
  • 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. 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).

Study Details

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.

Key Dates

Start date
Jan 28, 2026
Status verified
Feb 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

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

Arms

  • Experimental: rituximab combined with Daratumumab（anti-CD38 monoclonal antibody）
    Rituximab (375mg/m2) was given once (day1) and a Daratumumab (16mg/kg) was given four times (day8,15,22,29).
  • Active Comparator: rituximab
    Rituximab (375mg/m2) was given once.

Primary Outcome Measure

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

Central Contacts

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