Actively Recruiting
Anti-CD38 Antibody Treating Pediatric Primary Immune Thrombocytopenia (ITP)
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-11-28
60
Participants Needed
1
Research Sites
361 weeks
Total Duration
On this page
Sponsors
I
Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
B
Beijing Children's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
To evaluate the safety and efficacy of Anti-CD38 Antibody in the treatment of pediatric primary immune thrombocytopenia in patients who have not responded adequately or relapsed after first-line treatment and at least one second-line therapy including Anti-CD20 Antibody and/or TPO-RA, or those in whom no other second-line treatment options are suitable.
CONDITIONS
Official Title
Anti-CD38 Antibody Treating Pediatric Primary Immune Thrombocytopenia (ITP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6 years and above, male or female
- Diagnosed with immune thrombocytopenia (ITP)
- ITP diagnosis for 3 months or longer with platelet count below 30 x 10^9/L measured within 2 days before enrollment
- Failed to respond or relapsed after corticosteroid therapy and at least one second-line treatment including rituximab or TPO receptor agonists
- Completed any emergency ITP treatments at least 2 weeks before first study dose
- Provided signed informed consent
- Normal liver and kidney function
- ECOG physical state score of 2 or less
- New York Heart Association cardiac function class 2 or less
- Stable maintenance treatment (corticosteroids <=0.5 mg/kg prednisone, TPO receptor agonists) for at least 4 weeks before first dose
- Discontinued azathioprine, danazol, cyclosporin A, tacrolimus, or sirolimus at least 4 weeks before first dose
- Completed rituximab treatment more than 3 months prior
- More than 6 months since splenectomy
You will not qualify if you...
- Allergy to daratumumab or its components, or prior treatment with daratumumab with refractory response or response lasting less than 6 months
- Uncontrolled serious diseases of major organs such as cancer, liver failure, heart failure, or kidney failure
- HIV positive
- Active, uncontrolled infections including hepatitis B, hepatitis C, cytomegalovirus, EB virus, or syphilis
- Severe bleeding events like hemoptysis, gastrointestinal bleeding, or brain hemorrhage
- Current heart disease, arrhythmias needing treatment, or poorly controlled hypertension
- Thrombotic diseases such as pulmonary embolism, thrombosis, or atherosclerosis
- Past allogeneic stem cell or organ transplantation
- Mental disorders preventing informed consent or participation
- Persistent toxic symptoms from prior treatments
- Other serious illnesses limiting study participation (e.g., diabetes, severe heart failure, unstable angina, gastric ulcer)
- Septicemia or severe irregular bleeding
- Use of antiplatelet drugs concurrently
- Pregnant or breastfeeding women, or suspected pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Science and Blood Disease Hospital
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
T
Ting Sun, MD
CONTACT
Y
Yunfei Chen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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