eligibility_summary
Inclusion: 18–80, confirmed MZL (SMZL per criteria), measurable disease, needs systemic therapy, ≥1 prior systemic regimen with ≤PR or progression, ECOG 0–2, adequate labs/organ function (LVEF ≥50%), survival ≥3 mo, contraception, consent. Exclusion: refractory to obutinib+rituximab, severe allergy, other active cancer, CNS disease, major CV disease/QTc, bleeding/anticoagulation, DVT/PE, active HBV/HCV/HIV, serious lung disease, prior BTK/BCR/PI3K/Syk/BCL‑2 inhibitors.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT06134284 tests the OR regimen (orelabrutinib + rituximab) as second-line therapy for relapsed/refractory marginal zone lymphoma (MZL). Orelabrutinib is an oral, covalent small‑molecule Brutons tyrosine kinase (BTK) inhibitor that blocks B‑cell receptor (BCR) signaling, reducing proliferation and survival of malignant B cells. Rituximab is an intravenous chimeric anti‑CD20 monoclonal antibody that depletes CD20+ B cells via antibody‑dependent cellular cytotoxicity, complement activation, and apoptosis. Targeted cells/pathways: malignant marginal zone B cells, BTK/BCR signaling pathway and CD20 surface antigen. Post-response maintenance may use rituximab or obinutuzumab (type II anti‑CD20 mAb enhancing ADCC).