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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 Fixed Duration Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab Versus Venetoclax and Rituximab in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphomaa

Related Resources:
Molecule Overview Trial Enrollment
NCT04965493 show modal icon
Key Inclusion Criteria
  • Confirmed 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
  • Previously treated with at least one line of therapy that may include a covalent BTK inhibitor
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Platelets ≥50 x 109/L, hemoglobin ≥8 g/dL, and absolute neutrophil count ≥1.0 x 109/L
  • Adequate organ function
  • Estimated creatinine clearance ≥30 mL/min
Key Exclusion Criteria
  • Known or suspected Richter’s transformation at any time preceding enrollment
  • Uncontrolled immune thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia (AIHA)
  • Central nervous system (CNS) involvement
  • Significant cardiovascular disease
  • History of allogeneic stem cell transplantation (SCT) or chimeric antigen receptor-modified T-cell (CAR-T) therapy within the past 60 days
  • Active hepatitis B or C
  • Known active cytomegalovirus (CMV) infection
  • Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
  • Known HIV infection, regardless of cluster of differentiation 4 (CD4) count
  • Previously treated with venetoclax
  • Prior exposure to a non-covalent (reversible) BTK inhibitor
  • Patients requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist
  • Current treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers 
  • Vaccination with a live vaccine within 28 days prior to randomization
  • Patients with the following hypersensitivity:
    • Known hypersensitivity to any component or excipient of pirtobrutinib and venetoclax
    • Prior significant hypersensitivity to rituximab
    • Known allergy to allopurinol and inability to take uric acid lowering agents
a
This clinical trial is being conducted globally.
b
Administered orally QD.
c
Administered intravenously.
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