BTK Inhibitor
Pirtobrutinib
Phase
3
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 Lymphoma*
Related Resources:
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
*
This clinical trial is being conducted globally.
†
Pirtobrutinib is administered PO QD.
‡
Venetoclax is administered PO QD.
§
Rituximab is administered intravenously.
