eligibility_summary
Include: newly diagnosed WM needing therapy (IWWM‑11), treatment‑naive, ECOG 0–3, >3‑mo survival, adequate organs (CrCl ≥40, TBil ≤1.5×ULN, AST/ALT ≤2.5×, cardiac normal), ANC ≥1.5, Plt ≥50, Hb ≥60 (no recent support), no AF, able to take oral meds, screening complete, consented. Exclude: amyloidosis/POEMS, HIV/active hepatitis or HBV>10^2, unstable major disease, recent severe autoimmune/immunosuppression, serious infection, other active cancer, neuro/psych noncompliance, interfering issues, pregnant/lactating, investigator deems unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, single-arm trial in newly diagnosed Waldenström’s macroglobulinemia testing zanubrutinib plus BR (bendamustine/rituximab). Zanubrutinib: oral, second-generation small-molecule BTK inhibitor that blocks B-cell receptor (BCR) signaling, reducing proliferation and survival of malignant lymphoplasmacytic/B cells. Bendamustine: IV alkylating chemotherapeutic (nitrogen mustard) that crosslinks DNA, causing apoptosis of dividing B cells. Rituximab: IV anti-CD20 chimeric monoclonal antibody that depletes B cells via ADCC, CDC, and apoptosis. Target cells/pathways: CD20+ malignant B cells (WM clone), BTK/BCR signaling, DNA integrity/repair, immune effector mechanisms (complement and Fc-mediated cytotoxicity). Aim: deepen remission with time-limited therapy.