Actively Recruiting
Anti-CD38 Monoclonal Antibody Versus Rituximab in the Management of Primary Immune Thrombocytopenia (ITP)
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-02-11
160
Participants Needed
1
Research Sites
92 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 ITP patients.This study will be conducted in ITP patients who had not responded to or had relapsed after previous glucocorticoid treatment.
CONDITIONS
Official Title
Anti-CD38 Monoclonal Antibody Versus Rituximab in the Management of Primary Immune Thrombocytopenia (ITP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, male or female
- Diagnosed with primary immune thrombocytopenia for at least 3 months according to established guidelines
- Failed glucocorticoid therapy or relapsed after treatment, with prior response to standard first-line therapy
- Platelet count less than 30 x 10^9/L within 24 hours before first study dose and during screening
- ECOG performance status score of 2 or less
- Receiving stable maintenance therapy with glucocorticoids (prednisone ≤0.5 mg/kg) or TPO receptor agonists, limited to one concomitant medication stable for at least 4 weeks
- Negative pregnancy test for fertile females and use of effective contraception for fertile females and males during study and months after
- Able and willing 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 thrombocytopenia
- History of severe thrombotic or bleeding events within 12 months before study start
- Participation in other investigational drug studies within 4 weeks or 5 half-lives before first dose
- Use of anticoagulants or antiplatelet agents (like aspirin) within 3 weeks before first dose
- Emergency ITP treatments within 2 weeks before first dose
- Use of certain immunosuppressive medications within 4 weeks or 6 months before first dose
- Splenectomy within 6 months before first dose
- Receipt or planned receipt of live vaccines within 4 weeks before or during study
- Diagnosis of myelodysplastic syndromes or recent malignancy within 5 years (with exceptions)
- History of stem cell or organ transplantation
- Significant medical conditions posing safety risks, including major cardiac, respiratory, neurological, immune, mental, or metabolic diseases
- History of severe or recurrent infections or recent infections requiring systemic treatment
- Known or suspected immunosuppression or frequent infections
- Laboratory abnormalities including elevated liver enzymes, low neutrophils, hemoglobin, IgG, lymphocytes, or poor kidney function
- Positive tests for HIV, syphilis, hepatitis B or C infections
- Pregnancy or breastfeeding or intention to conceive during study
- Any other condition deemed unsuitable by investigators
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
L
Lei Zhang, MD
CONTACT
Y
Yunfei Chen, 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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