The main purpose of Part 1 of this study is to assess the efficacy and safety of 3 dose levels of Pirtobrutinib in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have received 1-3 lines of treatment including a covalent Bruton tyrosine kinase (BTK) inhibitor. The purpose of Part 2 of this study is to evaluate pirtobrutinib monotherapy in participants with treatment-naïve CLL/SLL with 17p deletions. Participation in Part 1 is expected to last approximately 3 years. Participation in Part 2 is expected to last up to 2 years.
Have confirmed diagnosis of CLL/SLL as defined by iwCLL 2018 criteria.
Part 1: Have received prior CLL/SLL treatment
Have received at least 1, but not more than 3 lines of prior treatment for CLL/SLL
Have received a covalent BTK inhibitor
Have received prior treatment with a BTK degrader or a noncovalent BTK inhibitor
Have a history of greater than or equal to (>=) Grade 3 bleeding due to treatment with a BTK inhibitor
Have known or suspected Richter's transformation
Have known or suspected history of central nervous system involvement by CLL/SLL
Parallel
Pirtobrutinib
DrugAdministered Orally.
Overall Response Rate
Overall response rate is defined as the proportion of participants who achieve the best overall response at or before the initiation of subsequent anticancer therapy of CR, CRi, nPR, or PR. ORR will be assessed using International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 response criteria.
Duration of Response
Duration of response is defined as the time from the date of the first documented CR, CRi, nPR, or PR to disease progression (per iwCLL 2018) or death from any cause.
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Loxo Oncology, Inc.
Lead sponsor
Eli Lilly and Company
Collaborator
