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PIPELINE > TRIAL OVERVIEW

Trial Information
Molecule Overview
BTK Inhibitor
Pirtobrutinib
Phase
3
Not Enrolling
A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphomaa
Related Resources:
Molecule Overview Trial Enrollment
BRUIN CLL-314 show modal icon
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
  • Adequate organ function
    • Platelets ≥50 x 10⁹/L or ≥30 x 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis
    • Hemoglobin ≥8 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 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
a
This clinical trial is being conducted globally.
b
Administered orally.
For information on trial enrollment, locations, and more, call 1-800-545-5979.
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or visit www.clinicaltrials.gov for more information on this trial