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

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
• •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