Using zanubrutinib to treat immune thrombocytopenia

Safety and Efficacy of Zanubrutinib in the Treatment of Immune Thrombocytopenia

This study tests if zanubrutinib can help people with immune thrombocytopenia who haven't had success with other treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China (Academic / other)
• Drugs / interventions: rituximab, zanubrutinib, Zebutinib, ibutinib, acalabrutinib
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT05214391 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of zanubrutinib in treating immune thrombocytopenia (ITP) in 30 patients. ITP is an autoimmune disease characterized by low platelet counts, leading to bleeding risks and a significant impact on patients' quality of life. The study focuses on patients who have not responded to conventional treatments and aims to provide a new therapeutic option for those with refractory ITP. Participants will receive zanubrutinib and be monitored for treatment response and safety outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of primary immune thrombocytopenia and a platelet count below 30 X 10^9/L who have failed previous treatments.

Not a fit: Patients with uncontrollable primary diseases of important organs or those with active infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients suffering from refractory immune thrombocytopenia.

How similar studies have performed: While there have been preliminary studies on BTK inhibitors for autoimmune diseases, this specific approach for treating immune thrombocytopenia is relatively novel.

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.

Where this trial is running

Tianjin, Tianjin Municipality

• Chinese Academy of Medical Science and Blood Disease 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

Conditions Immune Thrombocytopenia; Treatment