eligibility_summary
Eligible: adults with untreated WHO-defined mantle cell lymphoma (18–<65 or ≥65), ECOG 0–3, life expectancy ≥3 months, measurable disease (Lugano 2014), adequate organ/marrow function (HB≥60 g/L, ANC≥0.5, PLT≥50 [×10^9/L], AST/ALT≤2.5×ULN, bilirubin≤1.5×ULN, Ccr≥40 mL/min, LVEF≥50%). Exclude: concurrent tumors, strong/mod CYP3A inhibitors, pregnancy/lactation, allergy, no contraception, live vaccine ≤28 d, HIV, active HBV/HCV (if DNA/RNA detectable), severe coagulopathy/major organ disease, DVT/PE ≤12 mo, other safety risks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, open-label study of zanubrutinib-based regimens for newly diagnosed mantle cell lymphoma (MCL). Elderly arm: zanubrutinib + obinutuzumab induction (1 year), then zanubrutinib maintenance. Young high-risk arm (<65, TP53 mutation, blastoid/pleomorphic, or high sMIPI): zanubrutinib + R-BAC for 6 cycles, ASCT if eligible, then zanubrutinib maintenance. Mechanisms/types: Zanubrutinib is an oral, selective covalent BTK inhibitor (small-molecule TKI) that blocks B-cell receptor (BCR) signaling to reduce MCL B-cell proliferation/survival. Obinutuzumab is a type II, glycoengineered anti-CD20 monoclonal antibody inducing direct cell death and enhanced ADCC. R-BAC is chemoimmunotherapy causing cytotoxic DNA damage. ASCT consolidates remission after high-dose therapy. Targets: BTK/BCR pathway, CD20 on malignant B cells, DNA replication/repair in dividing lymphoma cells.