Safety and Efficacy of Zanubrutinib in the Treatment of Antiphospholipid Syndrome With Secondary Thrombocytopenia

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Jan 19, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called zanubrutinib to see how safe and effective it is for treating people with antiphospholipid syndrome who also have low platelet counts (a condition known as secondary thrombocytopenia). The trial aims to recruit 10 patients aged 18 and older who have been diagnosed with this syndrome and have not had success with standard steroid treatments. To be eligible, participants must have a platelet count below 30,000 and meet certain health criteria, such as stable liver and kidney function.

If you or a family member decides to participate, you can expect to receive zanubrutinib and be monitored closely by the research team for any side effects or changes in your condition. It’s important to note that this study cannot accept patients with severe underlying health issues, active infections, or certain other medical conditions. Participants will need to give their consent to join the trial and will be closely followed to ensure their safety throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18 and above, male or female；
• • Diagnosis of antiphospholipid syndrome；
• • Failure to receive glucocorticoid treatment in the past (the curative effect cannot be maintained, or recurs, or cannot be tolerated); Can not choose other second-line treatment, such as rituximab, cyclosporine, cyclophosphamide, etc.; Or rituximab, cyclosporine and other treatments are ineffective, relapsed or intolerable;
• • Plt \< 30×10\^9/L；
• • Liver and kidney function, such as ALT, AST, BUN, SCR \< 1.5 × upper limit of normal value, passing physical examination;
• • ECOG physical state score ≤ 2 points；
• • Cardiac function of the New York Society of Cardiac Function ≤ 2；
• • Signed and dated written informed consent.
• Exclusion Criteria:
• • Uncontrollable primary diseases of important organs, such as malignant tumors, liver failure, heart failure, renal failure and other diseases；
• • HIV positive;
• • Accompanied by uncontrollable active infection, including hepatitis B, hepatitis C, cytomegalovirus, EB virus and syphilis positive;
• • Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage, etc.;
• • At present, there are heart diseases, arrhythmias that need treatment or hypertension that researchers judge is poorly controlled;
• • Patients with thrombotic diseases such as new pulmonary embolism and unstable period of various arteriovenous thrombosis;
• • Those who have received allogeneic stem cell transplantation or organ transplantation in the past;
• • Patients with mental disorders who cannot normally obtain informed consent and conduct trials and follow-up;
• • Patients whose toxic symptoms caused by pre-trial treatment have not disappeared;
• • Other serious diseases that may limit the subject's participation in this test (such as diabetes; Severe cardiac insufficiency; Myocardial obstruction or unstable arrhythmia or unstable angina pectoris in recent 6 months; Gastric ulcer，etc.);
• • Patients with septicemia or other irregular severe bleeding;
• • Pregnant women, suspected pregnancies (positive pregnancy test for human chorionic gonadotropin in urine at screening) and lactating patients.