Actively Recruiting
Rituximab Combining 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
144 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 rituximab combining 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
Rituximab Combining 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, any gender
- Diagnosed with primary immune thrombocytopenia for at least 3 months
- Platelet count below 30 x 10^9/L confirmed by at least two tests within screening
- Failure of glucocorticoid therapy or relapse after treatment
- Completed any emergency ITP treatments at least 2 weeks before study start
- Liver and kidney function tests less than 1.5 times the upper normal limit
- ECOG performance status of 2 or less
- Cardiac function classified as NYHA class 2 or less
- Stable use of maintenance treatments like low-dose glucocorticoids or TPO receptor agonists for at least 4 weeks
- Discontinued certain immunosuppressive drugs at least 4 weeks prior
- Rituximab stopped for more than 6 months before starting
- At least 6 months since splenectomy before treatment
- Negative pregnancy test for fertile women and use of effective contraception for fertile men and women during and 90 days after study
- Ability to understand and follow study procedures and provide informed consent
You will not qualify if you...
- Uncontrolled serious diseases of major organs like cancer, liver failure, heart failure, or kidney failure
- HIV infection
- Active uncontrolled infections including hepatitis B or C, cytomegalovirus, Epstein-Barr virus, or syphilis
- Severe bleeding such as coughing blood, upper gastrointestinal bleeding, or brain hemorrhage
- Current heart disease, arrhythmias requiring treatment, or poorly controlled hypertension
- History of thrombotic diseases like pulmonary embolism or thrombosis
- Previous allogeneic stem cell or organ transplantation
- Mental disorders preventing informed consent or follow-up
- Persistent toxic symptoms from prior treatments
- Other serious conditions limiting study participation, including diabetes, severe heart problems, or gastric ulcers
- Septicemia or severe bleeding irregularities
- Concurrent use of antiplatelet drugs
- Pregnancy, suspected pregnancy, or breastfeeding
- Known allergies to study medications or their ingredients
- Any other conditions deemed unsuitable by the investigator
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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