Using zanubrutinib to treat antiphospholipid syndrome with low platelet counts

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of zanubrutinib in patients diagnosed with antiphospholipid syndrome (APS) who also experience secondary thrombocytopenia. The study aims to enroll 10 patients who have not responded to previous treatments such as glucocorticoids or other immunosuppressants. Zanubrutinib, a Bruton tyrosine kinase inhibitor, may help manage the symptoms of APS by targeting B cell signaling pathways. The trial will assess the impact of this treatment on platelet counts and overall disease management.

Why it matters

Who can join: the full rules

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.

Where it's running

• Chinese Academy of Medical Science and Blood Disease Hospital
  Tianjin, Tianjin Municipality, China Recruiting
• Institute of Hematology & Blood Diseases Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Principal investigator: Lei Zhang, MD — Chinese Academy of Medical Science and Blood Disease Hospital
• Study coordinator: Yunfei Chen, MD
• Email: chenyunfei@ihcams.ac.cn
• Phone: +8618502220788

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.