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 Pediatric Primary Immune Thrombocytopenia
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-02-24
60
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, an anti-CD20 monoclonal antibody, for treating pediatric primary immune thrombocytopenia (ITP) in patients aged 12 to 18 years who have not responded well or have relapsed after first-line glucocorticoid treatment. ITP is an autoimmune disease causing low platelet counts and bleeding, and current treatments for pediatric ITP have limited success, leading to ongoing challenges and reduced quality of life. This open, single-arm study will enroll 60 pediatric participants who will receive one intravenous infusion of 1000 mg Obinutuzumab. The study has two stages: the first 12 weeks focus on treatment safety and efficacy after infusion, and the following weeks up to 48 weeks monitor ongoing safety and lasting treatment effects without additional infusions. Participants will undergo regular assessments including platelet counts, bleeding evaluations, safety monitoring, and quality of life surveys over 12 months. Researchers will measure overall treatment response, duration of response, bleeding events, recurrence rate, and health-related quality of life to understand how Obinutuzumab affects pediatric ITP. Safety will be closely observed throughout the study period.
CONDITIONS
Brief Title
A Prospective, One-arm and Open Clinical Study of Obinutuzumab in the Treatment of Pediatric Primary Immune Thrombocytopenia (ITP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 12-18 years, male or female
- Diagnosed with persistent or chronic immune thrombocytopenia (ITP)
- Platelet count below 30 x 10^9/L measured at least twice during screening
- Failed or relapsed after previous hormone therapy or hormone dependent
- Previous emergency ITP treatments completed at least 2 weeks before first dose
- Signed and dated informed consent
- Liver and kidney function less than 1.5 times the upper limit of normal
- ECOG physical status score 2 points or less
- New York Heart Association cardiac function class 2 or less
- Stable maintenance treatment doses for at least 4 weeks before first dose
- Stopped certain immunosuppressive drugs at least 4 weeks before first dose
- More than 3 months since last rituximab treatment
- More than 6 months after splenectomy
You will not qualify if you...
- Primary diseases of major organs (liver, kidney, heart) or immune system diseases
- Secondary thrombocytopenia caused by other disorders
- Infection with HIV
- Active or uncontrolled infections including hepatitis B, C, CMV, EBV, or syphilis
- Severe bleeding such as hemoptysis, gastrointestinal or intracranial hemorrhage
- Heart disease needing treatment or poorly controlled hypertension
- History of venous or arterial thrombosis or atherosclerosis
- History of cancer or stem cell/organ transplant
- Mental disorders preventing informed consent or follow-up
- Ongoing toxic symptoms from previous treatments
- Serious diseases limiting study participation
- Septicemia or other bleeding disorders
- Use of antiplatelet drugs
- Any condition deemed unsuitable by investigators
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 treat pediatric primary immune thrombocytopenia (ITP). The safety and efficacy of the treatment are observed during this period.
1 infusion visit and multiple follow-up visits during 12 weeks
Duration - Week 12 to Week 48
Participants are monitored after treatment withdrawal to observe the ongoing safety and sustained efficacy of Obinutuzumab.
Periodic visits up to 36 weeks after treatment
Trial Site Locations
Total: 1 location
1
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Tianjin, China
Actively Recruiting
Research Team
T
Ting Sun, 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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