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

RECRUITINGPHASE3

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)

NCT05254743•Loxo Oncology, Inc.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
•Part 1 - Known 17p deletion status (wildtype or deleted). Part 2 - Must have deletion of 17p as determined by FISH testing
•Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
•Adequate organ function
•* Platelets greater than or equal to ≥ 50 x 10⁹/liter (L) or ≥30 x 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis,
•* Hemoglobin ≥8 grams/deciliter (g/dL) or ≥6 g/dL in participants with documented bone marrow involvement considered to impair hematopoiesis
•* Absolute neutrophil count ≥0.75 x 10⁹/L or ≥0.50 × 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis
•* Kidney function: Estimated creatinine clearance ≥30 milliliters per minute (mL/min)

Exclusion Criteria

•Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin's lymphoma at any time preceding enrollment
•Known or suspected central nervous system (CNS) involvement
•A significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic disease
•Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia \[AIHA\], idiopathic thrombocytopenic purpura \[ITP\])
•Significant cardiovascular disease including ejection fraction \< 40% and any grade ongoing atrial fibrillation or atrial flutter
•Hepatitis B or hepatitis C testing indicating active/ongoing infection, based on Screening laboratory tests
•Active cytomegalovirus (CMV) infection
•Active uncontrolled systemic bacterial, viral, or fungal infection
•Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
•Clinically significant active malabsorption syndrome or other condition likely to affect GI absorption of the oral-administered study treatments
+9 more criteria

Locations (144)

Pacific Cancer Medical Center, Inc

Anaheim, California, United States

TOI Clinical Research

Cerritos, California, United States

Stanford School of Medicine-Cancer Clinical Trials Office

Palo Alto, California, United States

California Cancer Associates for Research and Excellence

San Marcos, California, United States

Florida Cancer Specialists

Fort Myers, Florida, United States

Cancer Specialists of North Florida -St Augustine

Saint Augustine, Florida, United States

Florida Cancer Specialists East

West Palm Beach, Florida, United States

Hematology Oncology Clinic

Baton Rouge, Louisiana, United States

Tulane Cancer Center Office of Clinical Research

New Orleans, Louisiana, United States

American Oncology Partners of Maryland, PA

Bethesda, Maryland, United States

Key Dates

Start Date

July 22, 2022

Primary Completion Date

June 10, 2025

Completion Date

January 1, 2028

Last Updated

March 12, 2026

Enrollment

662

ESTIMATED participants

Conditions

Chronic Lymphocytic LeukemiaLeukemia, LymphocyticLeukemia, B-cellSmall Lymphocytic Lymphoma

Interventions

Pirtobrutinib

DRUG

Ibrutinib

DRUG

Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia

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