A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Prior treatment

• Prior systemic therapy for CLL/SLL
• Concurrent use of investigational agent or anticancer therapy except hormonal therapy
• Vaccination with a live vaccine within 28 days prior to randomization
• Patients with the following hypersensitivity:
  • Known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or bendamustine
  • Prior significant hypersensitivity to rituximab

Other illness

• Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia \[AIHA\], idiopathic thrombocytopenic purpura \[ITP\])
• Significant cardiovascular disease
• Active hepatitis B or hepatitis C
• Active cytomegalovirus (CMV) infection
• Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection

Lab values

• Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count

Other

• Known or suspected Richter's transformation at any time preceding enrollment
• Presence of 17p deletion
• Central nervous system (CNS) involvement
• Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist

• Confirmed diagnosis of CLL/SLL requiring therapy, per iwCLL 2018 criteria
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
• Adequate organ function
• Platelets greater than or equal to (≥)75 x 10⁹/liter (L) (≥50 × 10⁹/L for patients with evidence of bone marrow infiltrate), hemoglobin ≥8 grams/deciliter (g/dL), and absolute neutrophil count ≥0.75 x 10⁹/L
• Kidney function: Estimated creatinine clearance ≥40 milliliters per minute (mL/min)