eligibility_summary
Eligibility: Adults 18–75 with CD20+ DLBCL plus TP53 mutation and del(17p), ECOG 0–2, IPI>1, life expectancy ≥6 months, consent, no prior/concurrent malignancy. Exclude prior anti-lymphoma therapy or autologous SCT, primary CNS lymphoma, uncontrolled comorbidities/infections, LVEF ≤50%, lab dysfunction (ANC<1.5, Plt<75, ALT/AST>2×ULN, ALP/bili>1.5×, Cr>1.5× ULN), pregnancy/lactation, HIV, psychiatric noncompliance, active HBV (HBV DNA negative), exceptions: basal cell or cervical in situ.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, single-arm trial adding epigenetic therapy to R-CHOP for newly diagnosed CD20+ DLBCL with TP53 mutation plus del(17p). Interventions: 1) Chidamide (tucidinostat) – oral histone deacetylase inhibitor (HDAC1/2/3/10), epigenetic modulation to restore gene expression, promote apoptosis, and enhance chemo/immuno sensitivity. 2) Decitabine – DNA methyltransferase (DNMT) inhibitor, hypomethylating nucleoside analog, reactivates silenced tumor suppressors and induces p53-independent cytotoxicity/immune signaling. 3) R-CHOP: Rituximab (anti-CD20 monoclonal antibody, B-cell depletion via ADCC/CDC/apoptosis), Cyclophosphamide (alkylating agent), Doxorubicin (anthracycline/topoisomerase II inhibitor), Vincristine (vinca alkaloid, microtubule inhibitor), Prednisone (glucocorticoid, lympholytic). Targets: malignant CD20+ B cells, epigenetic (HDAC/DNMT) pathways, DNA damage/cell cycle, microtubules, and glucocorticoid signaling—aimed to overcome TP53-defective biology.