Actively Recruiting
Anti-CD38 Monoclonal Antibody Combined With Rituximab in the Management of Primary Immune Thrombocytopenia (ITP)
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-01-23
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This single-arm, open-label phase II study aim to evaluate the efficacy and safety of Daratumumab (anti-CD38 monoclonal antibody) combined 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 Combined With 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 as per guidelines
- Previous failure or relapse after glucocorticoid therapy
- Failed at least one thrombopoietin receptor agonist and rituximab/anti-CD38 antibody therapy, or relapse after splenectomy
- Platelet count below 30 × 10^9/L based on at least two tests
- ECOG performance status score of 2 or less
- Stable dose of one maintenance therapy (glucocorticoids ≤0.5 mg/kg prednisone or equivalent, or thrombopoietin receptor agonists) for at least 4 weeks before treatment
- Negative pregnancy test for fertile females and use of effective contraception during and after study
- Ability to understand and follow study protocol and provide informed consent
You will not qualify if you...
- Allergy to CD20 or CD38 monoclonal antibodies
- Diagnosis of autoimmune hemolytic anemia or secondary thrombocytopenic disorders
- History of serious thrombotic or bleeding events within 12 months before treatment
- Participation in other investigational drug studies within 4 weeks or 5 half-lives before treatment
- Use of anticoagulants or antiplatelet agents within 3 weeks before treatment
- Emergency treatment for ITP within 2 weeks before treatment
- Use of certain immunosuppressive medications within 4 weeks before treatment
- Treatment with CD20 or CD38 monoclonal antibodies or similar drugs within 3 months before treatment
- Splenectomy within 6 months before treatment
- Live vaccine use within 4 weeks before treatment or planned during study
- Diagnosis of myelodysplastic syndromes or recent malignancy within 5 years
- History of allogeneic stem cell or organ transplantation
- Significant medical conditions that increase safety risk or affect study results
- History of severe or poorly controlled infections or immunosuppression
- Abnormal laboratory results including elevated liver enzymes, low blood counts, or impaired kidney function
- Positive tests for HIV, syphilis, hepatitis B or C (with some exceptions)
- Pregnant or breastfeeding women or partners intending pregnancy during study
- Any other condition deemed unsuitable by investigators
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, 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
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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