Clinical Trial

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

Study acronym: BRUIN-MCL-321
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 34 amendments
This ClinicalTrials.gov record has been amended 34 times since 2020-12-04; most recent amendment 2026-05-13.
Status change: Recruiting → Active, Not Recruiting 2025-05-27
Status change: Active, Not Recruiting → Recruiting 2025-04-18
Status change: Recruiting → Active, Not Recruiting 2024-05-10
Status change: Not Yet Recruiting → Recruiting 2021-03-19
Trial Details
NCT Number NCT04662255
Lead Sponsor Loxo Oncology, Inc.
Collaborators: Eli Lilly and Company
Conditions Lymphoma, Mantle-Cell
Enrollment 500 participants
Start Date 2021-04-08
Primary Completion 2027-01 (estimated)
Study Completion 2028-04 (estimated)
Updated on ClinicalTrials.gov 2026-05-15