Zanubrutinib Combined With BR in the First-line Treatment of Waldenström's Macroglobulinemia

Inclusion criteria

• Previously untreated symptomatic Waldenström macroglobulinemia (WM) meeting IWWM-7 diagnostic criteria:

• Presence of monoclonal IgM-type immunoglobulin in serum
• Bone marrow infiltration by plasmacytoid lymphocytes or bone marrow biopsy showing small lymphocytes/plasma cells/plasmacytoid lymphocytes (any quantity) in the intertrabecular space
• Exclusion of other non-Hodgkin lymphoma subtypes
• Typical immunophenotype: CD5-/CD10-/CD19⁺/CD20⁺/CD23-/CD79b⁺ /sIgM⁺/CD138- clonal B-cells. Variant phenotypes may show CD5/CD10/CD23 /CD38 positivity or coexistence of clonal B-cells and plasma cells.
• MYD88 L265P mutation is detected in peripheral blood or bone marrow.
• Serum monoclonal IgM ≥5 g/L.

Exclusion criteria

• Co-morbidity of uncontrolled infection or autoimmune disease
• Co-morbidity of other active malignancy
• Co-morbidity of uncontrolled heart disease
• Co-morbidity of severe digestive system disorders precluding oral medication
• Seropositive for human immunodeficiency virus
• Hepatitis B virus (HBV)-DNA > 1000 copies/mL
• Seropositive for hepatitis C (except in the setting of a sustained virologic response)
• Neutrophil <1×10E9/L, platelet < 75×10E9/L, alanine transaminase (ALT) or aspertate aminotransferase (AST) > 2.5 × upper limit of normal (ULN), total bilirubin > 1.5 × ULN，eGFR < 30 mL/min, or receiving renal replacement therapy.