BTK Inhibitor
Pirtobrutinib
Phase
3
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:
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.
