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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 Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma*
Related Resources:
Molecule Overview Trial Enrollment
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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 ≥75 x 109/L (≥50 × 109/L for patients with evidence of bone marrow infiltrate), hemoglobin ≥8 g/dL, and absolute neutrophil count ≥0.75 x 109/L
  • Adequate organ function
  • Kidney function: Estimated creatinine clearance ≥40 mL/min
Key Exclusion Criteria
  • Known or suspected Richter’s transformation at any time preceding enrollment
  • Prior systemic therapy for CLL/SLL
  • Presence of 17p deletion
  • Central nervous system (CNS) involvement
  • 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, fungal, or parasitic infection
  • Known HIV infection, regardless of cluster of differentiation 4 (CD4) count
  • Concurrent use of investigational agent or anticancer therapy except hormonal therapy
  • Patients requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist
  • 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
*
This clinical trial is being conducted globally.
†
Pirtobrutinib is administered PO.
‡
Bendamustine is administered intravenously (IV).
§
Rituximab is administered IV.
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