Zanuburutinib in Relapsed and Refractory iMCD: a Prospective, Single-center, Single-arm Trial

• Status: Recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

Summary

To explore the effectiveness and safety of Zanuburutinib in relapsed and refractory idiopathic Multicentric Castleman's disease (iMCD) patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Zanubrutinib

Criteria

Inclusion Criteria:

• fulfilled the CDCN (Castleman Disease Collaborative Network) diagnostic criteria of iMCD

• relapsed or refractory disease. Relapsed = patients who ever achieved overall partial response (PR) or complete response (CR) with prior lines of therapy suffered from progressive disease (PD); refractory = iMCD patients who never achieved PR or CR with the first-line treatment but suffered from PD during treatment.

• Eastern Cooperative Oncology Group performance status (ECOG-PS ≤ 2)

• Neutrophil count ≥ 0.75×10^9/L, hemoglobin ≥ 70 g/L and platelet count > 30×10^9/L

• Total bilirubin ≤ 2 x ULN (upper limit of normal), AST（aspartate aminotransferase） or ALT（Alanine aminotransferase）≤ 2.5 x ULN

• INR （international normalized ratio) and APTT(activated partial thromboplastin time) ≤ 1.5 x ULN；eGFR>25ml/min/1.73m2

• estimated survival ≥ 3 months

• agree to take birth control methods during study period for women of reproductive age

• agree to provide informed consent

Exclusion Criteria:

• concurrent malignancies

• prior history of receiving any kind of BTK (Bruton's tyrosine kinase) inhibitors

• patients with SLE (systemic lupus erythematosus), HHV-8 (human herpesvirus-8) infection or POEMS syndrome

• History of major surgery or radiation therapy within 4 weeks before initiation of study drug

• history of myocardial infarction within 1 years

• patient with history of heart failure (NYHA 3 or 4) would be excluded unless his LVEF(left ventricular ejection fraction) ≥ 50% within 1 months

• primary cardiomyopathy; Qtc > 450ms for men and > 470ms for women

• breast feeding or pregnant women

• intolerance for oral regimen due to gastro-intestinal disorders

• uncontrolled infection

• positive HBV(hepatitis B virus)-DNA titers or positive HbsAg; positive HCV(hepatitis C virus)antibody; patients with HIV infection

• patients with history of bleeding disorders

• cerebral infarction or intracranial bleeding within 6 months

• active bleeding disorders within 2 months

• taking anti-platelet or anticoagulation drugs

• taking drugs which strongly inhibit P450 CYP3A

• patients or their relatives fail to understand the purpose of the study

• any other conditions that the investigators consider to be not appropriate for inclusion