NCT05254743

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

A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-314)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 662 (estimated)
• Sponsor: Loxo Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Lymphocytic Leukemia
• Leukemia, Lymphocytic
• Leukemia, B-cell
• Small Lymphocytic Lymphoma

Interventions

Type	Name	Description
DRUG	Pirtobrutinib	Administered orally.
DRUG	Ibrutinib	Administered orally.

Timeline

• Start date: 2022-07-22
• Primary completion: 2025-06-10
• Completion: 2028-01-01
• First posted: 2022-02-24
• Last updated: 2026-04-01

Locations

144 sites across 23 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, France, Germany, Hungary, Israel, Italy, Japan, New Zealand, Poland, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study