eligibility_summary
Planned for 6-cycle R-CHOP, newly diagnosed, CD20+ DLBCL (de novo or transformed FL) per WHO 2016: DLBCL NOS, HGBCL with MYC/BCL2 and/or BCL6 rearrangements (DLBCL morphology), T-cell/histiocyte-rich, EBV+ DLBCL NOS, FL grade 3b. Tissue available. IPI 2–5 (IPI2 ≤30%). ECOG 0–2 (may improve during prephase). ≥1 PET+ measurable lesion. Adequate labs, LVEF ≥50%. Exclude prior systemic DLBCL therapy/curative RT, prohibited histologies (incl CD20−), and significant cardiovascular disease.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05578976 is a Phase 3 trial in newly diagnosed CD20+ DLBCL comparing: (1) epcoritamab + R-CHOP followed by epcoritamab vs (2) R-CHOP followed by rituximab. Epcoritamab: subcutaneous bispecific IgG1 T‑cell engager (CD3×CD20) that redirects cytotoxic T cells to kill CD20+ B cells. Rituximab: anti‑CD20 monoclonal antibody depleting B cells via ADCC, complement (CDC), and apoptosis. Cyclophosphamide: alkylating prodrug causing DNA crosslinks. Doxorubicin: anthracycline intercalator/topoisomerase II inhibitor generating ROS. Vincristine: vinca alkaloid microtubule inhibitor arresting mitosis. Prednisone: glucocorticoid inducing lymphocyte apoptosis and anti‑inflammation. Targets/pathways: CD20 on malignant B cells, T‑cell activation via CD3, DNA integrity/replication (crosslinking, topo II inhibition), microtubule dynamics, glucocorticoid receptor signaling, immune effector mechanisms (ADCC/CDC).