RecruitingPhase 2NCT05199909

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

Prospective, Single Arm and Open Clinical Observation of Zanubrutinib in the Treatment of Antiphospholipid Syndrome With Secondary Thrombocytopenia

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

10 participants

Start Date

Jan 25, 2022

Study Type

INTERVENTIONAL

Conditions

Treatment Thrombocytopenia Antiphospholipid Syndrome

Summary

To evaluate the safety and efficacy of zanubrutinib in the treatment of antiphospholipid syndrome with secondary thrombocytopenia in 10 patients.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

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 Criteria12

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.

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Interventions

DRUGzanubrutinib

The initial dose is 80mg/day. If the treatment is ineffective after 4 weeks, and under the condition of good safety, the researcher will judge that the dosage should be added to 80mg twice/day，or a higher dose for oral maintenance. The maximum dose is 160mg twice a day. The duration of zanubrutinib is 24 weeks. In case of intolerable adverse reactions, such as severe infection, severe bleeding, hematopenia, arrhythmia, etc., investigator can reduce the dose of zanubrutinib, or withdraw from clinical trials as appropriate.