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

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Oct 17, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Obinutuzumab for children and teenagers aged 12 to 18 who have a condition known as Immune Thrombocytopenia (ITP). ITP is a condition where the body doesn’t produce enough platelets, which are important for blood clotting. This trial is specifically for patients who haven’t responded well to previous treatments, such as steroid medications, or have experienced a relapse after treatment. The goal is to see if Obinutuzumab is safe and effective in increasing platelet counts in these young patients.

To be eligible for this trial, participants must have a platelet count below a certain level and must have had difficulties with prior treatments. They should also be in relatively good health overall, without serious heart, liver, or kidney problems, and not have any active infections or other major illnesses. Those who join the study will receive Obinutuzumab and will be monitored closely for any side effects and improvements in their condition. This trial is currently looking for volunteers, so if you or someone you know fits the criteria and is interested, it could be an opportunity to help find a better treatment for ITP.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.