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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-321; NCT04666038
CLL/SLL
BTK Inhibitor
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*
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 × 109/L without granulocyte-colony stimulating factor support
- Hemoglobin ≥8 g/dL not requiring transfusion support or growth factors within 14 days of cycle 1 day 1
- Platelets ≥50 × 109/L not requiring transfusion support or growth factors within 14 days of cycle 1 day 1. If the investigator has chosen rituximab + bendamustine as the arm B treatment, platelets must be ≥75 × 109/L
- 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 noncovalent (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
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.