Actively Recruiting
Daratumumab Versus Rituximab in the Management of Pediatric Primary Immune Thrombocytopenia (ITP)
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-01-23
122
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This randomized, open-label study aim to compare the efficacy and safety of Daratumumab (anti-CD38 monoclonal antibody) with Rituximab in pediatric ITP patients.This study will be conducted in pediatric ITP patients who had not responded to or had relapsed after previous glucocorticoid treatment.
CONDITIONS
Official Title
Daratumumab Versus Rituximab in the Management of Pediatric Primary Immune Thrombocytopenia (ITP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6 to under 18 years, male or female
- Clinically diagnosed with primary immune thrombocytopenia for at least 3 months
- Failed glucocorticoid therapy with a history of response to first-line ITP treatment
- Platelet count below 30 x 10^9/L within 24 hours before first dose and during screening
- ECOG performance status score of 2 or less
- If on maintenance therapy, stable dose of one medication including glucocorticoids or TPO receptor agonists for at least 4 weeks
- Ability and willingness to follow study protocol and provide informed consent
You will not qualify if you...
- Previous use of CD20 or CD38 monoclonal antibodies
- Diagnosis of autoimmune hemolytic anemia or secondary thrombocytopenic disorders
- History of thrombotic or embolic events or severe bleeding within 12 months prior to study
- Participation in other investigational drug studies within 4 weeks or 5 half-lives before study
- Use of anticoagulants or antiplatelet agents within 3 weeks before study
- Emergency treatment for ITP within 2 weeks before study
- Use of certain immunosuppressive drugs within 4 weeks or 6 months depending on the drug
- Splenectomy within 6 months before study
- Receipt of live vaccines within 4 weeks before or planned during the study
- Diagnosis of myelodysplastic syndromes or recent history of malignancy
- History of organ or stem cell transplantation
- Significant medical history posing safety risks as judged by investigators
- History of severe or recurrent infections within screening periods
- Laboratory abnormalities including elevated liver enzymes, low blood counts, or impaired kidney function
- Positive for HIV, syphilis, hepatitis B surface antigen or active hepatitis C
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Science and Blood Disease Hospital
Tianjin, China
Actively Recruiting
Research Team
L
Lei Zhang, MD
CONTACT
T
Ting Sun, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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