eligibility_summary
Inclusion: ≥65, chemo‑intolerant DLBCL, ECOG 0–1, IPI ≤3, >3‑mo survival, measurable disease, adequate counts (ANC ≥1.0, PLT ≥75, Hb ≥80), liver/renal OK, normal heart, no conflicting illness/therapies, consent. Exclusion: neuro/psychiatric risk, concurrent/recent trials or anti‑tumor therapy (e.g., rituximab/BTK/azacitidine), autoimmune/immunodef, pregnancy, active/uncontrolled infection, CNS disease, major CV/respiratory/HTN/ulcer issues, HLH, HBV/HCV/HIV/CMV/syphilis.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial tests two subtype-tailored regimens in elderly, newly diagnosed DLBCL: Non-GCB: obutinib (orelabutinib, small-molecule covalent BTK inhibitor) + rituximab + cyclophosphamide + prednisone. GCB: decitabine (hypomethylating nucleoside analog, DNMT inhibitor) + rituximab + cyclophosphamide + prednisone. Mechanisms/targets: • Obutinib blocks BTK to inhibit B‑cell receptor signaling and downstream NF‑κB survival pathways in malignant B cells. • Decitabine inhibits DNA methyltransferase, causing DNA hypomethylation, re-expression of tumor suppressors, and cytotoxicity in proliferating lymphoma cells. • Rituximab (anti‑CD20 mAb) depletes CD20+ B cells via ADCC/CDC/apoptosis. • Cyclophosphamide (alkylator) crosslinks DNA, inducing apoptosis. • Prednisone (glucocorticoid) triggers lymphoid apoptosis and immunosuppression. Overall targets: CD20+ DLBCL cells, BTK/BCR pathway (non‑GCB), epigenetic/DNMT axis (GCB), DNA integrity and glucocorticoid receptor signaling.