This research study is being done to test the efficacy and safety of an investigational treatment called LOXO-305. LOXO-305 is an investigational (or experimental) drug that may treat certain cancers like leukemia and lymphomas, including mantle cell lymphoma (MCL). These cancers are dependent on or “addicted to” a protein made by the cancers called “BTK”. LOXO-305 is a “BTK inhibitor”—it is designed to block both normal and mutated forms of BTK in these cancers. Other drugs used to treat this type of cancer are ibrutinib, acalabrutinib, and zanubrutinib which are approved by the US FDA and other health authorities around the world. Patients on this study will receive either LOXO-305 (Arm A) or the study doctor’s choice of ibrutinib, acalabrutinib, or zanubrutinib (Arm B).
Patients with Previously Treated BTK Naïve Mantle Cell Lymphoma
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