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

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT07362199
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

Study Details

This single-arm, open-label phase II study aim to evaluate the efficacy and safety of Daratumumab (anti-CD38 monoclonal antibody) combined 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
Mar 31, 2026
Status verified
Jan 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
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 eight times (day8,15,22,29,36,43,50,57).

Primary Outcome Measure

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

Central Contacts

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