A Phase 3 Open-Label, Randomized Study of LOXO-305 versus Investigator Choice of BTK Inhibitor in Patients with Previously Treated BTK Inhibitor Naïve Mantle Cell Lymphoma (BRUIN MCL-321)

This research study is being done to test the effectivenss 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.

Are you Eligible? (Inclusion Criteria)

• At least 18 years of age
• Able to swallow oral study medication.
• no major surgery within 4 weeks prior to randomization
• life expectancy of at least 3 months