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Study identifier: NCT05254743 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Chronic Lymphocytic Leukemia · Leukemia, Lymphocytic · Leukemia, B-cell  ·  Sponsor: Loxo Oncology, Inc.

PhasePhase 3
Planned participants737
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or  ·  1-317-615-4559  ·  LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact  ·  clinical_inquiry_hub@lilly.com

Always discuss trial participation with your own doctor first.

Locations (143)

Pacific Cancer Medical Center, IncAnaheim, California, United StatesRecruiting
TOI Clinical ResearchCerritos, California, United StatesRecruiting
Stanford School of Medicine-Cancer Clinical Trials OfficePalo Alto, California, United StatesRecruiting
California Cancer Associates for Research and ExcellenceSan Marcos, California, United StatesActive Not Recruiting
Florida Cancer SpecialistsFort Myers, Florida, United StatesRecruiting
Cancer Specialists of North Florida -St AugustineSaint Augustine, Florida, United StatesRecruiting
Florida Cancer Specialists EastWest Palm Beach, Florida, United StatesRecruiting
Hematology Oncology ClinicBaton Rouge, Louisiana, United StatesActive Not Recruiting
Tulane Cancer Center Office of Clinical ResearchNew Orleans, Louisiana, United StatesActive Not Recruiting
American Oncology Partners of Maryland, PABethesda, Maryland, United StatesRecruiting
St. Vincent Frontier Cancer CenterBillings, Montana, United StatesRecruiting
Cancer Care Associates of YorkYork, Pennsylvania, United StatesActive Not Recruiting

+ 131 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05254743