eligibility_summary
Adults (≥18) with consent, ECOG 0–2, low‑grade FL (grade 1–2 or 3A/cFL), stage II–IV, no transformation, high tumor burden (GELF ≥1 or high‑risk FLIPI), ≥1 FDG‑avid lesion, minimal prior therapy (local RT ≤2 regions, ≤4 rituximab doses, recent steroids allowed), tissue for EZH2 testing, adequate organ function, contraception required. Excludes: active infection, pregnancy/breastfeeding, recent/competing cancers, CNS disease, recent investigational drugs, moderate/strong CYP3A modulators, uncontrolled HIV, active HCV/HBV, significant cardiac disease.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05551936: Single‑arm Phase I/II frontline study in high–tumor‑burden follicular lymphoma testing tazemetostat + rituximab with abbreviated bendamustine. Drugs/mechanisms: • Tazemetostat: oral small‑molecule EZH2 (PRC2) methyltransferase inhibitor, epigenetic therapy that reduces H3K27me3 and reprograms germinal center B‑cell gene expression (active in EZH2‑mutant and WT). • Rituximab: anti‑CD20 chimeric monoclonal antibody, depletes B cells via ADCC, CDC, and apoptosis. • Bendamustine: IV alkylating agent (nitrogen mustard with purine‑like properties), induces DNA crosslinks and apoptosis. Targets: malignant CD20+ follicular B cells, EZH2‑driven epigenetic pathway, DNA replication/repair and cell‑cycle/apoptotic pathways. Regimen: Bendamustine D1‑2 x3 cycles, rituximab D1 x6, tazemetostat BID x6 (dose‑escalated to RP2D).