A Prospective, One-arm and Open Clinical Study of Obinutuzumab in the Treatment of Pediatric Primary Immune Thrombocytopenia (ITP)

Trial details

Who runs it

Institute of Hematology & Blood Diseases Hospital, China

Trial code

NCT06094881

Record updated

24 February 2025

Original description

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 glucocorticoid treatment.Read full original descriptionShow less

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

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 glucocorticoid treatment.

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: Patients taking antiplatelet drugs at the same time; 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 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; Any medical history or condition that the investigator deems unsuitable for participation in the study; Subjects whose toxic symptoms caused by pre-trial treatment have not disappeared.

ClinicalTrials.gov NCT06094881