eligibility_summary
Eligible: adults ≥18, ECOG 0–3, untreated CD20+ histologically confirmed DLBCL (incl. transformed), CNS-IPI ≥4, adequate organ function (Cr <2×ULN, ALT/AST <2.5×, bilirubin <2×, EF ≥50%), ≥1 measurable lesion, consent. Exclude: CNS involvement, significant cardiac disease/MI <6 mo, HIV, pregnant/lactating, other active cancers, uncontrolled infection, HBV DNA >2×10^3/ml despite antivirals, unable to comply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, single-arm trial in newly diagnosed DLBCL with high CNS-IPI tests orelabrutinib plus R-CDOP. Orelabrutinib: small-molecule, covalent Bruton’s tyrosine kinase (BTK) inhibitor that blocks B-cell receptor (BCR) signaling and penetrates the blood–brain barrier to address CNS-relapse risk. R-CDOP components: rituximab (anti-CD20 monoclonal antibody, depletes B cells via ADCC/CDC/apoptosis), cyclophosphamide (alkylating agent, DNA crosslinks), liposomal doxorubicin (anthracycline/topoisomerase II inhibitor, reduced cardiotoxicity), vincristine (vinca alkaloid, microtubule inhibitor), prednisone (glucocorticoid, lympholytic). Targets: CD20+ malignant B cells, BTK/BCR pathway, DNA replication/repair, mitotic spindle, glucocorticoid signaling, CNS-risk B cells.