Status:
UNKNOWN
Zanuburutinib in Relapsed and Refractory iMCD: a Prospective, Single-center, Single-arm Trial
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Idiopathic Multicentric Castleman's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To explore the effectiveness and safety of Zanuburutinib in relapsed and refractory idiopathic Multicentric Castleman's disease (iMCD) patients.
Detailed Description
This is a single center, open-labeled , single arm, prospective study which includes a safety run-in phase. The primary endpoint is the overall response rate which includes complete response (CR) and ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04743687
Start Date
January 1 2021
End Date
January 1 2025
Last Update
February 9 2021
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100005