eligibility_summary
Eligibility: Untreated adult MCL (Ann Arbor II–IV) with measurable disease, ECOG 0–2, high-risk features (MIPI 4–11, Ki-67>50%, TP53 abnormality, blastic/pleomorphic), transplant-ineligible, adequate labs/organ function, life expectancy >12 weeks, able to comply. Exclude prior BTK inhibitor use, severe/uncontrolled comorbidities or active infections, HIV, psychiatric/noncompliance issues, or any condition deemed unsuitable by investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase 3, transplant-ineligible intermediate/high-risk mantle cell lymphoma. Interventions: - Orelabrutinib (oral small-molecule, covalent BTK inhibitor): blocks B-cell receptor (BCR)/BTK signaling to suppress survival and proliferation of malignant B cells. - Bendamustine (IV alkylating agent): induces DNA crosslinks and damage, triggering apoptosis. - Rituximab (IV anti-CD20 monoclonal antibody): depletes CD20+ B cells via complement-mediated cytotoxicity, ADCC, and apoptosis. - Venetoclax (oral BCL-2 inhibitor, BH3 mimetic): restores mitochondrial apoptosis by inhibiting anti‑apoptotic BCL‑2. Arms: Induction Orelabrutinib+Bendamustine+Rituximab vs Bendamustine+Rituximab, Maintenance Orelabrutinib±Venetoclax based on TP53 mutation/blastic-pleomorphic variants. Targets/pathways: malignant CD20+ B cells, BTK/BCR signaling, BCL‑2 anti-apoptotic pathway, DNA damage response, biomarker-guided (TP53) risk.