eligibility_summary
Eligible: adults ≥18 with histologically confirmed CD20+ MZL (MALT/SMZL/NMZL) progressed/recurrent or unsuitable after local therapy, ECOG 0–2, treatment indicated, adequate organs (CBC per marrow status, bilirubin ≤1.5×ULN, AST/ALT ≤2×ULN, creatinine ≤1.5×ULN, amylase ≤ULN, INR ≤1.5×ULN), life expectancy ≥3 mo, consent. Exclude: other active cancer, CNS/transformed disease, recent bleeding/surgery, active infections (HBV/HCV/HIV), psych/cognitive issues, pregnancy/no contraception, need CYP3A inhibitors/inducers, or other unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, single-arm first-line study in marginal zone lymphoma evaluating Orelabrutinib + Obinutuzumab (O2), a chemotherapy-free regimen. Orelabrutinib: oral, highly selective, covalent Bruton’s tyrosine kinase (BTK) inhibitor (targeted small molecule) that blocks B-cell receptor signaling and downstream NF-kB/PI3K-AKT/MAPK pathways, suppressing proliferation/survival of malignant B cells. Obinutuzumab: type II, glycoengineered anti-CD20 monoclonal antibody that depletes CD20+ B cells via enhanced ADCC/ADCP and direct cell death (some CDC). Targets: CD20+ marginal zone B cells and BTK in the BCR pathway. Responders get 1-year orelabrutinib maintenance.