This is a single-arm, multicenter, prospective, phase II study. The primary objective is to assess the efficacy and safety of orelabrutinib in treatment-naïve patients with marginal zone lymphoma.
Age ≥18 years, regardless of gender;
Patients with histopathologically confirmed stage I/II marginal zone lymphoma;
ECOG performance status score of 0-2;
Blood tests: Absolute neutrophil count (ANC) ≥1.5×10^9/L, platelets ≥75×10^9/L, hemoglobin ≥75g/L; if accompanied by bone marrow involvement, ANC ≥1.0×10^9/L, platelets ≥50×10^9/L, hemoglobin ≥50g/L;
Lymphoma involving the central nervous system or transformation to high-grade;
New York Heart Association (NYHA) Class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months prior to the first dose of the study drug, or arrhythmia requiring treatment at screening, with left ventricular ejection fraction (LVEF) <50%;
Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, or unclassified cardiomyopathy);
History of clinically significant QTc interval prolongation, or QTc interval >470 ms for females or >450 ms for males at screening;
Institute of Hematology & Blood Diseases Hospital, China
Lead sponsor
Beijing Tongren Hospital
Collaborator