Clinical Trial

A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Study acronym: BRUIN-CLL-314
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The purpose of Part 1 of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL; participants may or may not have already had treatment for their cancer. The purpose of Part 2 of this study evaluates pirtobrutinib monotherapy in treatment-naïve participants with CLL/SLL with 17p deletions. Participation could last up to six years for Part 1. Participation could last up to 2 years for Part 2.
Protocol Amendment History 2 changes
notable Enrollment increased: 662 -> 737 participants 2026-06-10
notable Primary completion pushed: 2025-06-10 -> 2027-10 2026-06-10
Trial Details
NCT Number NCT05254743
Lead Sponsor Loxo Oncology, Inc.
Conditions Chronic Lymphocytic Leukemia, Leukemia, Lymphocytic, Leukemia, B-cell, Small Lymphocytic Lymphoma
Enrollment 737 participants
Start Date 2022-07-22
Primary Completion 2027-10 (estimated)
Study Completion 2028-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-17