Low-dose Rituximab Regimens in Chinese Adult Patients With Immune Thrombocytopenia (ITP)

Inclusion Criteria:

• Age 18-60 years old;
• Diagnosis of primary immune thrombocytopenia according to the guidelines of American Society of Hematology for at least 3 months before inclusion;
• Platelet count <30×109/L (measured at least twice during the screening, with at least a 1-week interval);
• Failed or dependent on or relapsed after previous treatment with glucocorticoid;
• If on glucocorticoid maintenance therapy, dose ≤0.5 mg/kg prednisone or equivalent and stabilised for at least 4 weeks;
• Drugs such as azathioprine, danazol, cyclosporine A, tacrolimus, and sirolimus stopped for at least 4 weeks;
• Splenectomy more than 6 months previously;
• Previous rescue therapy of ITP (including methylprednisolone, platelet transfusion and IVIG) completed at least 2 weeks before the first administration;
• Liver and kidney function (including alanine aminotransferase, aspartate aminotransferase, total bilirubin, serum creatine, urea nitrogen, etc.) less than 1.5 times the upper limit of normal value;
• Eastern Cooperative Oncology Group performance status ≤2;
• Cardiac function classification (New York Heart Association) ≤2;
• Understand the research procedure and voluntarily sign a written informed consent form.

Exclusion Criteria:

• Patients with secondary thrombocytopenia (including myelodysplastic syndrome, aplastic anemia, common variant immunodeficiency disease, hereditary thrombocytopenia, drug-induced thrombocytopenia, pseudothrombocytopenia, connective tissue disease secondary thrombocytopenia, thrombocytopenia after liver disease, etc.);
• Previous treatment of RTX or allergic to RTX;
• Uncontrollable primary diseases of important organs (including malignant tumor, liver failure, heart failure, kidney failure and other diseases);
• HIV-positive status;
• Active infection including hepatitis B (HBV), hepatitis C (HCV) and other viral antigens or DNA, RNA positive; cytomegalovirus, Epstein-Barr virus, syphilis chronic or active infection. If HBV core antibodies are positive, HBV-DNA testing is required.
• Extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage, etc.
• Heart disease or arrhythmia need treatment, or poorly controlled hypertension;
• Thrombotic diseases including pulmonary embolism, thrombosis, atherosclerosis, etc.;
• Previously allogeneic stem cell transplantation or organ transplantation;
• Mental disorders who are unable to obtain informed consent normally and participate in trials and follow-up;
• Symptoms of toxicity from pre-trial treatment have not resolved;
• Other severe conditions that may limit participation in the trial (e.g., diabetes; severe cardiac insufficiency; myocardial infarction or unstable arrhythmia or unstable angina within the last 6 months; gastric ulcer; active autoimmune diseases, etc.);
• Sepsis or other irregular bleeding;
• Taking antiplatelet drugs;
• pregnancy, suspected pregnancy (urine human chorionic gonadotropin positive during screening) or lactation.