Phase 3  | 

BRUIN CLL-314; NCT05254743


BTK Inhibitor

A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma*

show modal icon BRUIN CLL-314
Key Inclusion Criteria
  • Diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) requiring therapy as defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Platelets ≥50 x 10⁹/L, hemoglobin ≥8 g/dL, and absolute neutrophil count ≥0.75 x 10⁹/L
  • Adequate organ function
  • Kidney function: Estimated creatinine clearance ≥30 mL/min
Key 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
  • Significant history of renal, neurologic, psychiatric, endocrine, metabolic, or immunologic disease
  • Active uncontrolled autoimmune cytopenia (eg, autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP])
  • Significant cardiovascular disease
  • Active hepatitis B or C
  • Active cytomegalovirus (CMV) infection
  • Active uncontrolled systemic bacterial, viral, or fungal infection
  • Known HIV infection, regardless of cluster of differentiation 4 (CD4) count
  • Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption
  • Ongoing inflammatory bowel disease
  • Prior exposure to BTK inhibitor (covalent or non-covalent)
  • Concurrent use of investigational agent or anticancer therapy, except hormonal therapy
  • Patients requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist
  • Use of ≥20 mg prednisone daily or equivalent dose of steroid with the first dose of study treatment
  • Vaccination with a live vaccine within 28 days prior to randomization
  • Chronic therapy with a strong cytochrome P450 3A (CYP3A) 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
  • Known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or ibrutinib
This clinical trial is being conducted globally.
Pirtobrutinib is administered PO.
Ibrutinib is administered PO.
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The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.