eligibility_summary
Eligibility: CD20+ B‑cell PCNSL with PR/CR/CRu after first‑line high‑dose methotrexate (± brain RT), randomize ≤75 days, MRI ≤30 days, prior CSF/vitreal disease must be CR, off steroids ≥2 weeks, KPS≥60/ECOG 0–2, adequate labs, consent and effective contraception. Exclude: systemic NHL, severe mAb allergy, other active malignancy, major infection/surgery or live vaccine ≤4 wks, HIV, HBV/HCV (exceptions if DNA/RNA−), pregnancy/lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial tests maintenance obinutuzumab vs observation in responders with primary CNS lymphoma. Obinutuzumab (Gazyva/GA101) is a glycoengineered humanized type II anti‑CD20 IgG1 monoclonal antibody (biologic), given IV on days 1–2 of cycle 1 and day 1 of subsequent cycles every 60 days for 2 years. Mechanism: binds CD20 on B cells, causing robust B‑cell depletion via enhanced Fcγ receptor–mediated antibody‑dependent cellular cytotoxicity (ADCC) and phagocytosis (ADCP), plus direct type II cell death, relatively less complement‑dependent cytotoxicity. Targets: CD20+ malignant B cells in PCNSL, engages innate effector cells (NK cells, macrophages) and B‑cell survival pathways. Non-therapeutic: cognitive and QoL assessments.