eligibility_summary
Inclusion: ≥60 with path-confirmed MCL (t(11,14) or cyclin D1+), stage II–IV needing treatment, ECOG 0–3, frail/unfit (e.g., ≥80, CIRS-G ≥6, LVEF ≤50%, major cardiac/respiratory comorbidity), able to swallow pills, consent, WOCBP neg test/contraception. Exclusion: prior systemic MCL therapy, fit for full-dose chemo, major CV/GI/infection/bleeding, AIHA/ITP, CNS disease, HBV/HCV, PPI, strong CYP3A4 or warfarin use, cytopenias/organ dysfunction, recent surgery/stroke/MI, other cancer (unless low risk), pregnancy, other trial, live vaccine.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II single-arm trial (UK, NCT05004064) in elderly/frail, previously untreated mantle cell lymphoma tests acalabrutinib plus rituximab. Acalabrutinib: oral, second‑generation small‑molecule Bruton’s tyrosine kinase (BTK) inhibitor that blocks B‑cell receptor (BCR) signaling (BTK→PLCγ2→NF‑kB/ERK), suppressing malignant B‑cell survival and proliferation. Rituximab: chimeric anti‑CD20 monoclonal antibody that depletes CD20+ B cells via antibody‑dependent cellular cytotoxicity, complement‑dependent cytotoxicity, and apoptosis. Targets: CD20‑expressing malignant B cells, BCR/BTK signaling axis and downstream NF‑kB/PI3K/ERK pathways, immune effector–mediated B‑cell clearance. Regimen: up to six 28‑day cycles (acalabrutinib 100 mg BID, rituximab day 1), then acalabrutinib maintenance until progression/toxicity.