eligibility_summary
Adults 18–70 with untreated, confirmed MCL (stage II–IV), ECOG 0–2, measurable disease, eligible for high‑dose therapy (incl Ara‑C), adequate counts/organ function (CrCl≥30, AST/ALT≤3×ULN, INR/APTT≤1.5×ULN), life expectancy >3 mo, contraception. Excludes CNS/leukemic non‑nodal MCL, recent major surgery or malignancy, active infection or HBV/HCV/HIV, major CV disease or QTcF>450, strong CYP3A meds, GI issues/can’t swallow, stroke/ICH <6 mo, drug hypersensitivity, pregnant/lactating, recent trial.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, single-arm trial in newly diagnosed mantle cell lymphoma testing: 1) Zanubrutinib: covalent small-molecule BTK inhibitor that blocks B‑cell receptor (BCR) signaling, impairing survival/proliferation of malignant B cells. 2) R-CHOP: rituximab (anti‑CD20 monoclonal antibody causing B‑cell depletion via ADCC/CDC/apoptosis), cyclophosphamide (alkylating DNA crosslinker), doxorubicin (anthracycline/topoisomerase II inhibitor), vincristine (vinca alkaloid, microtubule inhibitor), prednisone (glucocorticoid, lympholytic). 3) R-DHAP: rituximab, dexamethasone (glucocorticoid), high‑dose cytarabine (antimetabolite, DNA polymerase inhibitor), cisplatin (platinum DNA crosslinker). Induction alternates R-CHOP and R-DHAP, maintenance is zanubrutinib + rituximab. Targets: CD20+ B cells, BTK/BCR pathway, DNA replication/repair, mitotic spindle, and steroid‑induced apoptosis.