Actively Recruiting
A Prospective, One-arm and Open Clinical Study to Assess Safety and Efficacy of Anti-Human CD20 Monoclonal Antibody Obinutuzumab in the Treatment of Primary Immune Thrombocytopenia
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-02-21
110
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Obinutuzumab in treating immune thrombocytopenia (ITP), a condition where the immune system attacks platelets causing low platelet counts and bleeding. This study focuses on adults who did not respond well or relapsed after initial treatments like corticosteroids. ITP is a challenging disease with limited effective options, and this trial aims to address the urgent need for better treatments for patients with persistent or recurring ITP. Participants will receive a single intravenous infusion of 1000 mg Obinutuzumab, a type of anti-CD20 monoclonal antibody. The study has two stages: the first 12 weeks involve the core treatment and monitoring of safety and response, followed by a withdrawal period from week 12 to week 48 to observe ongoing safety and lasting effects after treatment. In total, 110 participants will be enrolled in this open-label, single-arm trial. During the study, participants will undergo regular assessments to evaluate treatment response, bleeding severity, and safety over one year. Key measures include the overall response within 12 weeks, sustained response rates at 6 and 12 months, recurrence-free survival, and safety monitoring. The study involves blood tests, physical exams, and questionnaires to track platelet counts and bleeding symptoms, ensuring close observation of the treatment's effects and participant health throughout the trial period.
CONDITIONS
Brief 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 above, any gender
- Diagnosed with immune thrombocytopenia (ITP) for at least 3 months
- Platelet count below 30 x 10^9/L confirmed twice within 2 days prior to treatment
- Inadequate response or relapse after corticosteroid therapy
- Previous emergency ITP treatments completed at least 2 weeks before first dose
- Signed informed consent
- Liver and kidney function tests less than 1.5 times the upper limit of normal
- ECOG physical state score of 2 or less
- New York Heart Association cardiac function class 2 or less
- Stable maintenance treatment dose for at least 4 weeks before first administration
- Discontinued certain immunosuppressive drugs at least 4 weeks before first administration
- More than 3 months since last rituximab treatment
- More than 6 months since splenectomy
You will not qualify if you...
- Primary diseases of important organs (liver, kidney, heart) or immune system diseases
- Secondary thrombocytopenia from other causes like bone marrow failure or malignancy
- HIV infection
- Uncontrolled or active infections including hepatitis B or C, cytomegalovirus, EB virus, or syphilis
- Severe bleeding such as hemoptysis, gastrointestinal, or brain hemorrhage
- Heart disease requiring treatment or poorly controlled hypertension
- Venous or arterial thrombosis or atherosclerosis
- History of malignant tumors or organ/stem cell transplantation
- Mental disorders preventing informed consent or trial participation
- Unresolved toxic symptoms from prior treatments
- Serious illnesses limiting trial participation (e.g., diabetes, severe cardiac conditions, autoimmune diseases)
- Septicemia or irregular bleeding
- Pregnant or nursing women
- Concurrent use of antiplatelet drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 1 to Week 12
Participants receive a single intravenous infusion of 1000mg Obinutuzumab to observe its safety and efficacy in treating immune thrombocytopenia.
1 infusion visit and multiple follow-up visits during 12 weeks
Duration - Week 12 to Week 48
Participants are observed for safety and continuous efficacy of Obinutuzumab after treatment ends.
Periodic visits up to 36 weeks after treatment
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
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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