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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT05254743

Public ClinicalTrials.gov record NCT05254743. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 19, 2026, 1:43 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05254743
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Loxo Oncology, Inc.
Industry
Enrollment
737 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 21, 2022
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027
Last update posted
Aug 16, 2026

2022 – 2028

United States locations

U.S. sites
19
U.S. states
11
U.S. cities
18
Facility City State ZIP Site status
Pacific Cancer Medical Center, Inc Anaheim California 92801 Recruiting
TOI Clinical Research Cerritos California 90703 Recruiting
Stanford School of Medicine-Cancer Clinical Trials Office Palo Alto California 94305 Recruiting
California Cancer Associates for Research and Excellence San Marcos California 92069 Active, not recruiting
Florida Cancer Specialists Fort Myers Florida 33916-2233 Recruiting
Cancer Specialists of North Florida -St Augustine Saint Augustine Florida 32086 Recruiting
Florida Cancer Specialists East West Palm Beach Florida 33401 Recruiting
Hematology Oncology Clinic Baton Rouge Louisiana 70809 Active, not recruiting
Tulane Cancer Center Office of Clinical Research New Orleans Louisiana 70112 Active, not recruiting
American Oncology Partners of Maryland, PA Bethesda Maryland 20817 Recruiting
St. Vincent Frontier Cancer Center Billings Montana 59102 Recruiting
Cancer Care Associates Of York York Pennsylvania 17403 Active, not recruiting
Prisma Health Cancer Institute Greenville South Carolina 29605 Active, not recruiting
Sarah Cannon Research Institute SCRI Nashville Tennessee 37203 Recruiting
Kelsey Research Foundation Houston Texas 77025 Active, not recruiting
Lumi Research Kingwood Texas 77339 Recruiting
Virginia Cancer Institute Richmond Virginia 23230 Recruiting
Medical Oncology Associates, PS Spokane Washington 99208 Recruiting
MultiCare Health System Institute for Research and Innovation Spokane Washington 99218 Active, not recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 124 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05254743, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 16, 2026 · Synced Sep 19, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05254743 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →