A Prospective, One-arm and Open Clinical Study of Obinutuzumab in the Treatment of Immune Thrombocytopenia

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Aug 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Obinutuzumab to see if it is safe and effective for treating a condition known as immune thrombocytopenia (ITP). ITP is a disorder where the immune system mistakenly attacks and destroys platelets, which are important for blood clotting. This trial is specifically for adults aged 18 and older who have not responded well to previous treatments or have had a relapse after initial treatment. To be eligible, participants need to have a low platelet count and have completed any emergency treatments at least two weeks prior to starting the trial.

If you join the trial, you will be monitored closely by healthcare professionals to assess how well the medication works and to check for any side effects. The trial is currently recruiting participants, and it’s open to all genders. It's important to know that there are specific criteria for joining, such as not having certain serious health conditions or infections. If you're considering participating, you will need to provide informed consent, meaning you understand the trial and agree to take part. Overall, this study aims to find a better treatment option for those struggling with ITP.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18 and above, male or female
• • Conform to the diagnostic criteria of immune Thrombocytopenia (ITP)
• • Diagnosis of ITP ≥3 months, and with a platelet count of \<30 X 109/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 109/L）
• • Failure to achieve response or relapse after corticosteroid therapy
• • 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;
• • Female subjects who are nursing or pregnant/suspected pregnant (positive pregnancy tests for human chorionic gonadotropin in urine during screening).
• • Patients taking antiplatelet drugs at the same time;