eligibility_summary
Adults (≥18) with pathologically confirmed CD5+ DLBCL, ≥1 measurable/evaluable lesion (Lugano 2014), ECOG 0–2, expected survival ≥3 months, and adequate marrow, liver, and renal function. Exclude: mixed/transformed lymphoma, CNS involvement, prior BTK inhibitor use, drug contraindications, HIV/AIDS, inability to swallow/absorb tablets, pregnancy/lactation or no contraception, inability to consent, or investigator deems unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial tests orelabrutinib added to R-CHOP for untreated CD5-positive DLBCL, with possible orelabrutinib maintenance after CR. Orelabrutinib: oral, covalent small-molecule BTK inhibitor that blocks B-cell receptor (BCR) signaling and survival. Rituximab: anti-CD20 monoclonal antibody causing B-cell depletion via ADCC/CDC and apoptosis. Cyclophosphamide: alkylating prodrug causing DNA crosslinks. Doxorubicin: anthracycline DNA intercalator/topoisomerase II inhibitor generating ROS. Vincristine: vinca alkaloid inhibiting microtubule polymerization/mitosis. Prednisone: glucocorticoid inducing lymphocyte apoptosis. Targets: malignant CD5+ CD20+ B cells, pathways include BCR/BTK signaling, DNA integrity/replication, mitotic spindle, and immune-mediated B-cell clearance.