Anti-CD38 Antibody Treating Children With Primary Immune Thrombocytopenia (ITP)

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT06838962
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

  • Daratumumab Injection — DRUG
    intravenous Daratumumab administration This study adopts a prospective, single arm, open design method. Thirty subjects were enrolled in the study and were treated with CD38 monoclonal antibody (Daratumumab 16mg/kg/w) for 4 weeks. The first stage is the main research stage (d1-w4), which is the core treatment period. The subjects will receive intravenous infusion of 16mg/kg Daratumumab once a week for 4 weeks to observe the safety and efficacy during treatment. The second stage (w5-w24) is the stage of withdrawal from the visit, mainly to observe the safety and continuous efficacy of Daratumumab after treatment.

Study Details

To evaluate the safety and efficacy of Anti-CD38 Antibody in the treatment of primary immune thrombocytopenia in patients who have failed first-line treatment.

Key Dates

Start date
Aug 1, 2024
Status verified
Dec 2024
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention (Daratumumab)
    30 enrolled subjects: once a week x 4 doses

Primary Outcome Measure

Efficacy after Daratumumab treatment within 8 weeks [ Time Frame: 8 weeks ]

Central Contacts

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