eligibility_summary
Eligible: adults (≥18) with WHO 5th mantle cell lymphoma, del(17p)/TP53 mutation or age ≥65, or <65 and chemo-intolerant, life expectancy >3 months, CCR ≥50 mL/min or eGFR ≥60, INR/aPTT ≤1.5×ULN, LVEF ≥50, consent. Exclude: pregnant/lactating, active HBV/HCV, immunodeficiency, recent CHF/NYHA III–IV/LVEF <50, allergy, other malignancy, severe infection, substance abuse/other interfering conditions, unsuitable by investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06136351 is a single-arm Phase 2 study in newly diagnosed mantle cell lymphoma patients who are elderly, TP53-altered, or chemotherapy-intolerant, testing zanubrutinib + bendamustine + rituximab. Drugs and mechanisms: • Zanubrutinib: small-molecule covalent BTK inhibitor, blocks B-cell receptor (BCR) signaling, suppressing BTK→NF-κB/PI3K-MAPK pathways to reduce malignant B‑cell survival and proliferation. • Rituximab: anti-CD20 monoclonal antibody (immunotherapy), depletes CD20+ B cells via ADCC, CDC, and apoptosis. • Bendamustine: alkylating chemotherapeutic (nitrogen mustard), induces DNA crosslinks and damage, triggering apoptosis. Target cells/pathways: malignant CD20+ B cells in MCL, BCR/BTK/NF-κB signaling axis, immune effector mechanisms against B cells, DNA damage response and cell-cycle arrest/apoptosis, including in high-risk TP53-altered disease.