A Clinical Trial to Assess Safety and Efficacy of Daratumumab in the Treatment of Primary Immune Thrombocytopenia

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT05562882
Phase
PHASE2
Status
Unknown

Conditions

  • Immune Thrombocytopenia

Eligibility Criteria

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

Interventions

Study Details

A single-center, open-label, off-label use investigator-initiated clinical study to explore the clinical activity and safety of daratumumab in adult ITP patients who have not responded adequately or relapsed after first-line treatment and at least one second-line therapy including rituximab and/or TPO-RA.

Key Dates

Start date
Dec 10, 2022
Status verified
May 2024
Primary completion
Jan 31, 2025
Completion
Dec 31, 2025

Study Design

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

Arms

  • Experimental: Intervention
    Daratumumab once a week x 8 doses

Primary Outcome Measure

Evaluate of response after daratumumab treatment [ Time Frame: 8 weeks ]

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