eligibility_summary
Eligible: ≥18, MCL with t(11,14)/cyclin D1, stage II–IV or leukemic non‑nodal with splenomegaly+BM, measurable disease, ECOG 0–2 (or 3 if due to MCL), adequate organ/marrow, available tumor/BM sample, contraception, negative pregnancy, consent. Exclude: CNS MCL, active other cancer (exceptions), severe illness, major CV disease/QTc>480, active infection, HIV viremia, active HBV/HCV, PML, stroke/ICH ≤6 mo, AIHA/ITP, GI bleed/malabsorption, hypersensitivity, pregnancy/breastfeeding, prior MCL therapy (except limited RT), strong CYP3A4 meds/warfarin, major surgery/live vaccine ≤28 d, immunosuppression, other trials/noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Drugs/interventions: Acalabrutinib (small‑molecule, covalent Bruton’s tyrosine kinase [BTK] inhibitor) blocks B‑cell receptor (BCR) signaling to reduce proliferation/survival, Venetoclax (small‑molecule BH3‑mimetic BCL‑2 inhibitor) restores apoptosis in BCL‑2–dependent cells, Rituximab (chimeric anti‑CD20 monoclonal antibody, IgG1) depletes B cells via ADCC/CDC and apoptosis. Targets: Malignant B cells in mantle cell lymphoma, key pathways/antigens include BTK/BCR signaling, anti‑apoptotic BCL‑2 pathway, and CD20 on B cells. Phase II, chemo‑free triplet induction (13 cycles) in treatment‑naïve MCL, primary endpoint: MRD‑negative complete response at end of induction, MRD‑negative CRs randomized to continued acalabrutinib vs observation, with option for acalabrutinib retreatment at relapse.