Clinical Trial

A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Study acronym: BRUIN CLL-313
Active, Not Recruiting Phase 3
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Summary
The purpose of this study is to compare the efficacy and safety of pirtobrutinib (LOXO-305; Arm A) compared to BR (Arm B) in patients with CLL/SLL who have not been treated. Participation could last up to five years.
Protocol Amendment History 24 amendments
This ClinicalTrials.gov record has been amended 24 times since 2021-08-24; most recent amendment 2026-01-21.
Status change: Recruiting → Active, Not Recruiting 2024-04-04
Status change: Not Yet Recruiting → Recruiting 2021-10-08
Trial Details
NCT Number NCT05023980
Lead Sponsor Loxo Oncology, Inc.
Collaborators: Eli Lilly and Company
Conditions Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Enrollment 309 participants
Start Date 2021-09-23
Primary Completion 2025-07-11 (estimated)
Study Completion 2027-10 (estimated)
Updated on ClinicalTrials.gov 2026-01-22