eligibility_summary
Eligibility: Adults 18–75 with histologically confirmed CD20+ DLBCL, MYC≥40% and BCL2≥50%, ECOG 0–2, IPI>1, life expectancy ≥6 months, consent, no prior or concurrent malignancy (except skin BCC/cervical in situ). Exclude prior lymphoma therapy or ASCT, primary CNS lymphoma, uncontrolled comorbidities, LVEF≤50%, abnormal labs, pregnancy/lactation, HIV, noncompliance, and active HBV (HBV DNA must be negative if HBsAg+ or HBcAb+).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, single-arm study in untreated DLBCL with MYC/BCL2 double expression tests CR-CHOP plus subtype-specific add-ons. Regimen: R-CHOP (rituximab anti-CD20 mAb, cyclophosphamide alkylator, doxorubicin anthracycline/topo II inhibitor, vincristine vinca alkaloid, prednisone glucocorticoid) + chidamide/tucidinostat (selective HDAC inhibitor). Add-ons: Cluster 1 gets a PD-1 inhibitor (checkpoint-blocking mAb), Clusters 2/3 get orelabrutinib (covalent BTK inhibitor), TP53-mut gets decitabine (hypomethylating DNMT inhibitor). Targets/pathways: CD20+ malignant B cells (ADCC/CDC/apoptosis), DNA crosslinking/topo II, microtubules, glucocorticoid-mediated lympholysis, epigenetic regulation via HDAC and DNA methylation, BCR-BTK signaling, PD-1/PD-L1 axis to restore T-cell cytotoxicity. Designed for MYC/BCL2-high (DEL) biology, with chidamide maintenance after CR.