eligibility_summary
Eligible: men <75 with newly diagnosed DLBCL (WHO 2017), stage III–IV, no prior lymphoma therapy/radiation, life expectancy ≥6 mo, adequate marrow/liver/kidney/coagulation, consent and contraception for 12 mo post-rituximab. Exclude: R-CHOP intolerance, CNS involvement/PCNSL/PMBL, prior transplant, recent major surgery/trauma/other trials, other cancer ≤3 y, serious/uncontrolled disease incl major CV ≤6 mo, bleeding, neuro, absorption issues, live vaccine ≤4 w, warfarin/VKA, prior doxorubicin ≥150 mg/m2, or investigator judgment.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase III RCT in male, newly diagnosed stage III–IV DLBCL compares high‑dose rituximab (500 mg/m²) vs standard dose (375 mg/m²), each with R‑CHOP x6 plus 2 rituximab maintenance cycles. Interventions/mechanisms: Rituximab—chimeric anti‑CD20 IgG1 monoclonal antibody (immunotherapy) depleting B cells via complement‑dependent cytotoxicity (CDC), antibody‑dependent cellular cytotoxicity (ADCC), and apoptosis. CHOP chemotherapy: cyclophosphamide (alkylating DNA crosslinker), doxorubicin (anthracycline/topoisomerase II inhibitor, DNA intercalation/ROS), vincristine (vinca alkaloid microtubule inhibitor), prednisone (glucocorticoid inducing lymphocyte apoptosis). Targets/pathways: malignant CD20+ B cells, complement and Fc‑effector pathways, DNA damage/repair and topoisomerase II, microtubule dynamics, glucocorticoid receptor–mediated apoptosis.