The DART Study- Daratumumab Treatment in ITP

Sponsor
Ostfold Hospital Trust
Study ID
NCT04703621
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

Study Details

A multicenter clinical, open-label total dose-escalating phase II study with safety run-in to explore the clinical activity, total dosage, and safety of daratumumab in adult ITP patients who have not responded adequately or relapsed after corticosteroids and at least one second-line therapy including rituximab and/or TPO-RA.

Key Dates

Start date
Jan 21, 2021
Status verified
Sep 2023
Primary completion
Apr 30, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
21 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention ( safety run-in, cohort 1, cohort 2)
    Safety run-in( 3 patients): daratumumab once a week x 4 doses. If no worsening of thrombocytopenia can be attributed to study treatment or any other life-threatening events, the study will proceed to the main part. Cohort 1 ( 9 patients): daratumumab once a week x 8 doses If response is \<100%: Cohort 2 ( 9 patients): daratumumab once a week x 8 doses followed by daratumumab every 2 weeks x 2 doses

Primary Outcome Measure

to evaluate of response after daratumumab treatment [ Time Frame: 12-16 weeks ]