eligibility_summary
Adults ≥18 with untreated, CD20+ low/medium‑risk MCL (Ki‑67 ≤30% or ≤50%, nodes ≤3–5 cm), ECOG ≤2, adequate marrow/organ function. Exclude: CNS MCL, high‑risk features (blastoid/pleomorphic, Ki‑67>50%, bulky>5 cm, TP53/del17p, MYC, complex karyotype), cardiac disease/QTc>470, bleeding diathesis, active HIV/HBV/HCV/CMV, malabsorption, pregnancy/lactation, strong CYP3A/P‑gp drugs, warfarin, recent stroke/ICH, live vaccines, prior severe BTKi toxicity, other active cancer, prior allo‑transplant, uncontrolled autoimmune cytopenias.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase II, chemotherapy-free first-line therapy in low/intermediate-risk mantle cell lymphoma combining pirtobrutinib + rituximab. Drugs and mechanisms: • Pirtobrutinib (LOXO-305): small-molecule, highly selective, reversible (non-covalent) Bruton’s tyrosine kinase (BTK) inhibitor. Blocks B-cell receptor (BCR) signaling, including C481-mutant BTK, suppressing downstream NF-κB/PI3K-AKT/MAPK survival pathways and B-cell trafficking/adhesion. • Rituximab (Rituxan): chimeric anti-CD20 IgG1 monoclonal antibody that depletes CD20+ B cells via ADCC, complement-dependent cytotoxicity, and apoptosis. Targets: malignant CD20+ mantle cell B lymphocytes, BTK/BCR pathway. Design includes MRD-adapted pirtobrutinib duration (stop if MRD-negative, continue if MRD-positive). Primary endpoint: ORR after 3 cycles.