eligibility_summary
Untreated, measurable MCL (cyclin D1+ or t(11,14)), any stage. Age ≥70 or 60–69 with comorbidities, not SCT candidates/decline. ECOG 0–2, adequate counts/organ function (ANC ≥750, platelets ≥75k or ≥50k if marrow, CrCl ≥30). No prior BTK/anti‑CD20/SCT, no stage I RT. Exclude major cardiac disease/QTcF>480, recent stroke/ICH, severe bleeding, GI malabsorption, live vaccines, hypersensitivity, strong CYP3A4 modulators. Controlled HIV/HBV/HCV ok. Archival tissue required.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3 randomized trial in older, previously untreated mantle cell lymphoma. Induction uses zanubrutinib (oral, small‑molecule, covalent Bruton’s tyrosine kinase [BTK] inhibitor) plus rituximab (IV anti‑CD20 monoclonal antibody). Patients in complete remission are randomized to continuous zanubrutinib vs intermittent (stop and restart at first progression). Mechanisms: rituximab targets CD20 on B cells to induce immune-mediated depletion (ADCC/CDC/apoptosis), zanubrutinib inhibits BTK to shut down B‑cell receptor (BCR) signaling, reducing malignant B‑cell survival, proliferation, and trafficking. Targets/pathways: malignant mature B cells in MCL, CD20 antigen, BTK/BCR signaling axis. Study assesses PFS, OS, toxicity/QOL, and MRD dynamics under continuous vs intermittent BTK blockade.