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

Protocol No
LOXO-BTK-20019
Principal Investigator
Nirav Shah
Phase
III
Summary
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).
Description
Patients with Previously Treated BTK Naïve Mantle Cell Lymphoma
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL