Title: A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator Choice of BTK Inhibitor in Patients With Previously Treated BTK Inhibitor Naive Mantle Cell Lymphoma (BRUIN MCL-321)
Principal Investigators: Michael Roberts, MD, Arizona Oncology Associates; Jamal Misleh, MD, Medical Oncology Hematology Consultants; Miguel Islas-Ohlmayer, MD, Oncology/ Hematology Care, Inc; Ian Flinn, MD, Sarah Cannon Research Institute; Henrik Illum, MD, Texas Oncology, Bedford; Monte Jones, MD, Texas Oncology, McKinney; Tammy Roque, MD, Texas Oncology, P.A., Sherman
Description: Researchers are conducting a phase 3 global, randomized, open-label study comparing LOXO-305 to investigator’s choice of ibrutinib, acalabrutinib or zanubrutinib in patients with mantle cell lymphoma who have received 1 or more lines of therapy and are Bruton tyrosine kinase inhibitor naive. The primary outcome measure of the trial is to compare progression-free survival after the administration of LOXO-305 as monotherapy compared with investigator choice of covalent BTK inhibitor monotherapy in patients with previously treated mantle cell lymphoma. Secondary outcome measures include the comparison of event-free survival and time to treatment failure between treatment arms and time to worsening of mantle cell lymphoma-related symptoms.
This study is sponsored by Loxo Oncology, Inc.
Clinicaltrials.gov. Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL) (BRUIN-MCL-321). NCT04662255. Accessed April 23, 2021.