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EventsOncology Pipeline
Loxo@Lilly aims to create medicines that make life better for all those affected by cancer around the world. Bringing together the focus and spirit of a biotech with the scale, resources, and heritage of Lilly, our team is focused on rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating oncology medicines that unequivocally show early signs of clinical activity and will matter to patients.
BRUIN CLL-322; NCT04965493
CLL/SLL
BTK Inhibitor
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*
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
Contact the Loxo Oncology at Lilly Clinical Trial Team
Visit www.clinicaltrials.gov for more information on this trial.
Need additional information or have a question:
The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.