NCT04662255

Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)

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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Loxo Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lymphoma, Mantle-Cell

Interventions

Type	Name	Description
DRUG	Pirtobrutinib	Oral
DRUG	Ibrutinib	Oral
DRUG	Acalabrutinib	Oral
DRUG	Zanubrutinib	Oral

Timeline

• Start date: 2021-04-08
• Primary completion: 2027-01-01
• Completion: 2028-04-01
• First posted: 2020-12-10
• Last updated: 2025-05-28

Locations

189 sites across 24 countries: United States, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Israel, Italy, Japan, Netherlands, New Zealand, Poland, Portugal, Russia, South Korea, Spain, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study