Actively Recruiting
A Prospective, One-arm and Open Clinical Study of Obinutuzumab in the Treatment of Immune Thrombocytopenia
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-02-21
110
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the safety and efficacy of Obinutuzumab in the treatment of immune thrombocytopenia in patients who have not responded adequately or relapsed after first-line treatment.
CONDITIONS
Official Title
A Prospective, One-arm and Open Clinical Study of Obinutuzumab in the Treatment of Immune Thrombocytopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and older, male or female
- Diagnosed with immune thrombocytopenia (ITP) for at least 3 months
- Platelet count less than 30 x 10^9/L measured twice at least one week apart during screening
- Inadequate response or relapse after corticosteroid therapy
- Completed any emergency ITP treatments at least 2 weeks before study start
- Signed informed consent
- Liver and kidney function tests less than 1.5 times the upper normal limit
- ECOG physical score of 2 or less
- New York Heart Association cardiac function classification of 2 or less
- Stable doses of maintenance treatments (corticosteroids ≤0.5 mg/kg prednisone, TPO receptor agonists) for at least 4 weeks before study
- Immunosuppressive drugs such as azathioprine, danazol, cyclosporin A, tacrolimus, sirolimus stopped at least 4 weeks before study
- More than 3 months since last rituximab treatment
- More than 6 months since splenectomy
You will not qualify if you...
- Presence of primary diseases affecting important organs (liver, kidney, heart) or immune system diseases
- Secondary thrombocytopenia from causes such as connective tissue disorders, bone marrow failure, myelodysplastic syndrome, malignancy, drugs, inherited thrombocytopenia, immune deficiencies, or lymphoma
- Infection with HIV
- Active or uncontrolled infections including hepatitis B, hepatitis C, cytomegalovirus, EB virus, or positive syphilis antigen
- Severe bleeding such as hemoptysis, gastrointestinal bleeding, or intracranial hemorrhage
- Heart disease requiring treatment or poorly controlled hypertension
- History of venous or arterial thrombosis, atherosclerosis, or related diseases
- History of malignant solid tumors or prior allogeneic stem cell or organ transplantation
- Mental disorders preventing informed consent or trial participation
- Persistent toxic symptoms from prior treatments
- Other serious illnesses limiting trial participation (e.g., diabetes, severe cardiac insufficiency, unstable heart conditions, gastric ulcer, active autoimmune disease)
- Septicemia or unusual bleeding
- Nursing or pregnant females (positive pregnancy test during screening)
- Current use of antiplatelet drugs
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, China, 300020
Actively Recruiting
Research Team
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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