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

Recruiting now · Phase 3

Conditions studied: Chronic Lymphocytic Leukemia, Leukemia, Lymphocytic, Leukemia, B-cell, Small Lymphocytic Lymphoma

In brief

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.

Key facts

Study ID

NCT05254743

Run by

Loxo Oncology, Inc.

People needed

737

Starts

2022-07-22

Expected to finish

2028-01-01

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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
• Ongoing inflammatory bowel disease
• Previous treatment for CLL/SLL - Part 1: Treatment-naïve and previously treated, except prior exposure to BTK inhibitor (covalent or noncovalent).
• Part 2: participants must be treatment naïve
• Concurrent use of investigational agent or anticancer therapy except hormonal therapy
• Participants requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
• Use of > 20 mg prednisone daily or equivalent dose of steroid at the time of first dose of study drug
• Vaccination with a live vaccine within 28 days prior to randomization
• Participants receiving chronic therapy with a strong cytochrome P450 (CYP)3A inhibitor (except posaconazole and voriconazole) which cannot be stopped within 3-5 half lives of the CYP3A inhibitor therapy prior to start of study drug treatment
• Participants with known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or ibrutinib

Where it is running

• Hemocentro Unicamp — Campinas, Brazil (enrolling)
• Centro Gaucho Integrado - Mae de Deus Center — Porto Alegre, Brazil (enrolling)
• VITAZ — Sint-Niklaas, Belgium (enrolling)
• Upeclin - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UNESP — Botucatu, Brazil (enrolling)
• Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer — Curitiba, Brazil (enrolling)
• Instituto do Câncer - Hospital São Vicente de Paulo — Passo Fundo, Brazil (enrolling)
• TOI Clinical Research — Cerritos, California, United States (enrolling)
• Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg — Leuven, Belgium (enrolling)
• Florida Cancer Specialists — Fort Myers, Florida, United States (enrolling)
• Fundação Pio XII - Hospital de Câncer de Barretos — Barretos, Brazil (enrolling)
• Hospital Uopeccan - Centro de Pesquisa Clinica — Cascavel, Brazil (enrolling)
• Stanford School of Medicine-Cancer Clinical Trials Office — Palo Alto, California, United States (enrolling)
• Sarah Cannon Research Institute SCRI — Nashville, Tennessee, United States (enrolling)
• Florida Cancer Specialists East — West Palm Beach, Florida, United States (enrolling)
• Lumi Research — Kingwood, Texas, United States (enrolling)
• Virginia Cancer Institute — Richmond, Virginia, United States (enrolling)
• Medical Oncology Associates, PS — Spokane, Washington, United States (enrolling)
• Pacific Cancer Medical Center, Inc — Anaheim, California, United States (enrolling)
• Alexander Fleming — Ciudad Autónoma de Buenos Aire, Argentina (enrolling)
• American Oncology Partners of Maryland, PA — Bethesda, Maryland, United States (enrolling)
• Clínica de Nefrología, Urología y Enfermedades Cardiovasculares — Santa Fe, Argentina (enrolling)
• St. Vincent Frontier Cancer Center — Billings, Montana, United States (enrolling)
• Cancer Specialists of North Florida -St Augustine — Saint Augustine, Florida, United States (enrolling)
• The Perth Blood Institute — West Perth, Australia (enrolling)
• Hospital de Clínicas de Ribeirão Preto — Ribeirão Preto, Brazil (enrolling)

Full record on ClinicalTrials.gov

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