eligibility_summary
Adults with marginal zone lymphoma (MALT/SMZL/NMZL): Cohort A age 18–70 fit for chemo, Cohort B age ≥70 or <70 unfit for chemo, progressive/relapsed or unsuitable for local therapy, ECOG 0–3 (3 if tumor‑related), treatment indication, adequate labs, life expectancy ≥3 months, consent. Exclude: other active cancers, CNS/transform, major cardiac disease, bleeding/DVT/PE, GI malabsorption, transplant, recent surgery, active HBV/HCV/HIV, severe lung disease, prior BTK/BCR/BCL2 drugs, pregnancy, strong CYP3A interactions, other risks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, multicenter study in untreated marginal zone lymphoma testing: (A) orelabrutinib + bendamustine + rituximab in younger/fit patients, (B) orelabrutinib + obinutuzumab in older/less-fit patients, responders receive orelabrutinib maintenance. Drugs/mechanisms (type): Orelabrutinib—oral, covalent Bruton’s tyrosine kinase (BTK) inhibitor (targeted therapy) that blocks B‑cell receptor (BCR) signaling and downstream NF‑κB/AKT survival pathways, Bendamustine—alkylating chemotherapeutic causing DNA crosslinking and apoptosis, Rituximab—chimeric anti‑CD20 IgG1 monoclonal antibody (mAb) inducing B‑cell depletion via ADCC/CDC/apoptosis, Obinutuzumab—glycoengineered type II anti‑CD20 IgG1 mAb with enhanced ADCC and direct cell death. Targets: CD20+ malignant marginal zone B cells, pathways: BCR/BTK signaling, DNA damage/apoptosis, and immune effector cytotoxicity.