Primary Immune Thrombocytopenia
Conditions
Interventions
Therapy Group:Zanubrutinib (80 mg, 2 times/day, for a total of 12 weeks) combined with Rituximab (375 mg/m2, 1 intravenous infusion) regimen
Sponsors
The Second Affiliated Hospital of Kunming Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-70 years old, male or female, the course of disease is more than 3 months, excluding other diseases, patients diagnosed with ITP; 2. ITP patients with ineffective or hormone-dependent first-line hormone therapy; 3. Platelet count <=30*10^9/L or platelet count <50*10^9/L with bleeding symptoms; 4. Those who can understand the procedures and methods of this study, voluntarily sign the informed consent form, and strictly abide by the clinical trial protocol; 5. Particiants agree to take effective contraceptive measures during the trial and within 12 months after the last dose.
Exclusion criteria
Exclusion criteria: 1. ITP patients with severe bleeding: patients with a bleeding score higher than 5 points. 2. Patients with a history of allergy to zanubrutinib, rituximab, and murine; 3. Active pulmonary tuberculosis and other uncontrolled active infections; 4. Secondary thrombocytopenia; 5. Active hepatitis B virus infection: patients with HBSAg positive or hepatitis B virus DNA copy number exceeding the standard; 6. Angina pectoris, heart failure, myocardial infarction, severe arrhythmia, etc.; 7. Inoculated with live vaccine within 4 weeks before screening; 8. Renal dysfunction, serum creatinine > 1.5 times the upper limit of normal; 9. Abnormal liver function, AST or ALT > 2.5 times the upper limit of normal; 10. Suffering from cancer or a history of cancer; 11. A history of serious mental illness; 12. Received any other study drug within 30 days before receiving the first dose of the study drug, or 5 times the drug half-life of the drug; 13. Pregnant and lactating women; 14. Other researchers think that it is not suitable to participate in the research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate;Overall Response Rate;Overall Response Rate;Complete Response Rate; | — |
Countries
China
Contacts
Public ContactZePing Zhou
The Second Affiliated Hospital of Kunming Medical University
Outcome results
None listed