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)
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 is a study for participants with a type of blood cancer called mantle cell lymphoma (MCL). The main purpose is to compare pirtobrutinib (LOXO-305) to other drugs that work in a similar way that have already been approved by the United States Food and Drug Administration (US FDA). Participation could last up to two years, and possibly longer, if the disease does not progress.
This is a Phase 3 global, randomized, open-label study comparing pirtobrutinib (Arm A) to investigator's choice of ibrutinib, acalabrutinib or zanubrutinib (Arm B) in MCL patients who have received 1 or more lines of therapy and are BTK inhibitor naïve.
Inclusion Criteria:
Exclusion Criteria:
Aldeota, Fortaliza 60115-281, Brazil
Rio Preto, São Paulo 15090-000, Brazil
Santo André, São Paulo 09060-650, Brazil
Curitiba- PR, 80060 240, Brazil
Luoyang, Henan 471003, China
Bordeaux, Aquitaine 33076, France
Politiers, Politiers 86021, France
Rouen, Seine-Maritime 76038, France
Münster, North Rhine-Westphalia 48149, Germany
Meldola, Emilia-Romagna 47014, Italy
Osaka Sayama-shi, Osaka 589 8511, Japan
Koto, Tokyo 135-8550, Japan
Saint Petersburg, 191024, Russia
Namdong-gu, Incheon-gwangyeoksi [Incheon] 21565, South Korea
Seoul, Seoul-teukbyeolsi [Seoul] 03722, South Korea
Taipei City, Taipei 114, Taiwan
Chiayi County, 61363, Taiwan