eligibility_summary
Eligible: untreated MCL, age ≥65 or 60–<65 and ineligible/refusing transplant, Ann Arbor stage II–IV (stage II needing systemic therapy), histologically confirmed MCL with Cyclin D1+ and/or t(11,14), measurable disease (LN >1.5 cm or extranodal >1.0 cm), ECOG 0–2. Exclude: other malignancy unless disease-free ≥2 years, significant GI absorption issues/total gastrectomy, pre-transplant debulking intent, strong CYP3A inhibitors/inducers, CNS lymphoma.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Randomized, double-blind phase 3 trial in untreated mantle cell lymphoma comparing orelabrutinib + bendamustine + rituximab (BR) vs BR. Interventions and mechanisms: Orelabrutinib—oral small‑molecule, highly selective, irreversible Bruton’s tyrosine kinase (BTK) inhibitor, blocks B‑cell receptor (BCR) signaling and downstream NF‑κB survival pathways. Bendamustine—IV cytotoxic alkylating agent (nitrogen mustard/antimetabolite) causing DNA crosslinks, replication arrest, and apoptosis. Rituximab—IV anti‑CD20 monoclonal antibody depleting B cells via CDC, ADCC, and apoptosis. Targets: malignant CD20+ B cells, BCR/BTK/NF‑κB signaling, DNA integrity/repair pathways.