A Prospective, One-arm and Open Clinical Study of Zanubrutinib in the Treatment of Immune 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 a condition known as immune thrombocytopenia (ITP). ITP is a disorder where the body doesn't have enough platelets, which are needed for blood to clot properly. The trial will involve 30 participants who are 18 years or older and have been diagnosed with ITP for at least three months. To qualify, participants must have a very low platelet count and should have already tried other treatments, including corticosteroids and at least one other therapy like rituximab, without success.

If you or a family member are interested in participating, it’s important to know that you would undergo health checks to ensure you’re eligible. Participants will receive zanubrutinib and will be monitored for any side effects and how well the treatment works. This study is currently recruiting, so it’s a good opportunity for those looking for new treatment options for ITP. However, some individuals, like those with severe heart or liver issues, active infections, or those who are pregnant or breastfeeding, will not be able to join the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18 and above, male or female；
• • Conform to the diagnostic criteria of immune Thrombocytopenia (ITP)；
• • Diagnosis of ITP\>3 months；
• • Primary ITP with a platelet count of \<30 X 109/L prior to inclusion with failure to achieve response or relapse after corticosteroid therapy, and at least one second-line therapy including rituximab \>12 weeks ago and/or TPO-RAs.
• • 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 pulmonary embolism, thrombosis and atherosclerosis;
• • 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;
• • Patients taking antiplatelet drugs at the same time;
• • Pregnant women, suspected pregnancies (positive pregnancy test for human chorionic gonadotropin in urine at screening) and lactating patients.