Status:
RECRUITING
A Prospective, One-arm and Open Clinical Study of Obinutuzumab in the Treatment of Pediatric Primary Immune Thrombocytopenia (ITP)
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Immune Thrombocytopenia
Treatment
Eligibility:
All Genders
12-18 years
Phase:
PHASE2
Brief Summary
To evaluate the safety and efficacy of Obinutuzumab in the treatment of pediatric primary immune thrombocytopenia in patients who have not responded adequately or relapsed after first-line glucocortic...
Detailed Description
Immune thrombocytopenia (ITP) is an organ-specific autoimmune disease, which is characterized by decreased platelet count and skin and mucosal bleeding. ITP is a kind of disease with increased platele...
Eligibility Criteria
Inclusion
- Age 12-18 years old, male or female
- Conform to the diagnostic criteria of persistent or chronic immune Thrombocytopenia (ITP)
- With a platelet count of \<30 X 10\^9/L measured within 2 days prior to administration（Platelet counts were measured at least 2 times during screening (at least 1 week apart) with platelets\<30 X 10\^9/L）
- Failure or recurrence of previous hormonal therapy or hormone dependence
- The previous emergency treatment of ITP (e.g. methylprednisolone, platelet transfusion, IVIG transfusion) must be completed at least 2 weeks before the first administration
- Signed and dated written informed consent
- With Liver and kidney function\<1.5×upper limit of normal， such as ALT、AST，BUN，Cre，etc.
- ECOG physical state score ≤ 2 points
- Cardiac function of the New York Society of Cardiac Function ≤ 2
- Patients receiving maintenance treatment (including corticosteroids (less than or equal to 0.5mg/kg prednisone), TPO receptor agonists, etc.) must have a stable dose at least 4 weeks before the first administration, and azathioprine, danazol, cyclosporin A, tacrolimus, sirolimus, etc. must be stopped at least 4 weeks before the first administration; The end of rituximab treatment was\>3 months；More than 6 months after splenectomy.
Exclusion
- Subjects with primary disease of important organs (liver, kidney, heart, etc.), or with immune system diseases;
- Secondary thrombocytopenia caused by various reasons, such as connective tissue disorders, bone marrow hematopoietic failure disease, myelodysplastic syndrome, malignancy, drugs, inherited thrombocytopenia, common variable immune deficiency, lymphoma, etc.;
- Subjects infected with human immunodeficiency virus (HIV);
- Uncontrollable or active infections during the screening period, including hepatitis B, hepatitis C, cytomegalovirus, EB virus, or positive syphilis antigen;
- Subjects with extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage;
- Subjects with heart disease that requires treatment or hypertension that has been judged by researchers to be poorly controlled currently;
- Subjects with any venous or arterial thrombosis, atherosclerosis, and other diseases;
- Subjects with a history of malignant solid tumor or have received allogeneic stem cell transplantation or organ transplantation;
- Subjects with mental disorders who are unable to sign normal informed consent and conduct trials and follow-up;
- Subjects whose toxic symptoms caused by pre-trial treatment have not disappeared;
- Subjects with other serious diseases that may limit their participation in this trial (diabetes; severe cardiac insufficiency; myocardial obstruction or unstable arrhythmia or unstable angina pectoris in the last 6 months; gastric ulcer; active autoimmune disease, etc.);
- Subjects with septicemia or other irregular bleeding;
- Patients taking antiplatelet drugs at the same time;
- Any medical history or condition that the investigator deems unsuitable for participation in the study.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06094881
Start Date
December 1 2023
End Date
November 1 2026
Last Update
February 24 2025
Active Locations (1)
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1
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Tianjin, China