eligibility_summary
Eligibility: Adults ≥18 with R/R DLBCL (NOS, T-cell/histiocyte-rich, EBV+, composite lymphoma with DLBCL relapse, or transformed low-grade lymphoma with DLBCL failure), 1–3 prior lines, measurable disease, ECOG 0–2, adequate organs, life ≥3 mo, consent, recent tumor biopsy (safety stage), HDT/SCT-ineligible if not transplanted. Exclude: other malignancy <3y, CNS lymphoma, double/triple-hit HGBL, PMBCL, prior allo-SCT, prior anti-CD19 or gemcitabine+platinum failure, unresolved ≥G2 toxicity, major CV/neurologic disease, high VTE risk without prophylaxis, uncontrolled infection, HIV or active HBV/HCV.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3 randomized trial in relapsed/refractory DLBCL comparing: (1) Tafasitamab (humanized, Fc‑engineered anti‑CD19 monoclonal antibody) + lenalidomide (IMiD) + gemcitabine/oxaliplatin vs (2) Rituximab (chimeric anti‑CD20 monoclonal antibody) + gemcitabine/oxaliplatin. Mechanisms: Tafasitamab binds CD19 on B cells, enhancing ADCC/ADCP and apoptosis. Lenalidomide binds cereblon, promotes IKZF1/3 degradation, boosts NK/T‑cell function and cytokines, augmenting antibody‑mediated cytotoxicity, also antiangiogenic. Gemcitabine is a nucleoside antimetabolite inhibiting ribonucleotide reductase/DNA synthesis (S‑phase). Oxaliplatin is a platinum agent causing DNA crosslinks and apoptosis. Rituximab targets CD20 inducing CDC/ADCC/apoptosis. Targets: CD19+/CD20+ malignant B cells, cereblon/IKZF pathway, immune effector (NK/complement), DNA replication/repair.