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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 Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma*

Related Resources:
Molecule Overview Trial Enrollment
NCT04666038 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 a covalent BTK inhibitor
  • Eastern Cooperative Oncology Group (ECOG) status of 0-2
  • Absolute neutrophil count ≥0.75 x 109/L without granulocyte-colony-stimulating factor support, or ≥0.50 x 109/L in patients with documented bone marrow involvement considered to impair hematopoiesis. Granulocyte-colony-stimulating factor support is permitted in patients with documented bone marrow involvement
  • Hemoglobin ≥8 g/dL or ≥6 g/dL in patients with documented bone marrow involvement considered to impair hematopoiesis. Transfusion support is permitted in patients with bone marrow involvement
  • Platelets ≥50 x 109/L. If an investigator has chosen bendamustine/rituximab as the arm B treatment, platelets must be ≥75 x 109/L. Patients may enroll below these thresholds if the investigator determines the cytopenia is related to bone marrow involvement considered to impair hematopoiesis. Patients with a platelet count <30 x 109/L are excluded
  • AST and ALT ≤3.0 x upper limit of normal (ULN); total bilirubin ≤1.5 x ULN
  • Estimated creatinine clearance of ≥30 mL/min
Key Exclusion Criteria
  • Known or suspected Richter's transformation at any time preceding enrollment
  • Known or suspected history of central nervous system (CNS) involvement by CLL/SLL
  • Ongoing drug-induced liver injury
  • Active uncontrolled autoimmune cytopenia 
  • Significant cardiovascular disease
  • History of allogeneic or autologous 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
  • Clinically significant active malabsorption syndrome or inflammatory bowel disease
  • 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 and/or strong P-gp inhibitors
  • 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, idelalisib, and bendamustine
    • Prior significant hypersensitivity to rituximab
*
This clinical trial is being conducted globally.
†
Pirtobrutinib is administered 200 mg PO QD until progression or unacceptable toxicity. 
‡
Idelalisib is administered 150 mg PO BID. 
§
Rituximab is administered intravenously (IV) as 8 total infusions. 
‖
Bendamustine is administered 70 mg/m2 IV on days 1 and 2 of cycles 1-6. 
Rituximab is administered IV as 6 total infusions. 
For information on trial enrollment, locations, and more, call 1-800-545-5979.
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