Overview
The main purpose of this study is to assess the efficacy and safety of 3 dose levels of Pirtobrutinib in participants with relapsed or refractory 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 study is expected to last approximately 3 years.
Eligibility
Inclusion Criteria:
- Have confirmed diagnosis of CLL/SLL as defined by these iwCLL 2018 criteria.
- 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 a requirement for therapy consistent with iwCLL 2018 criteria for initiation of therapy
- Capable of swallowing oral study medication.
- Have an Eastern Cooperative Oncology Group Performance Status (ECOG) score of 0 to 2.
Exclusion Criteria:
- Have received prior treatment with a BTK degrader and 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
- Previous or concurrent cancer distinct from CLL/SLL within 3 years before
randomization. Exceptions may occur with documented sponsor approval. Examples
- include
-
- nonmelanoma skin cancer or lentigo maligna melanoma
- cervical carcinoma in situ
- localized prostate cancer undergoing active surveillance, and
- localized (for example, lymph node negative) breast cancer with no evidence of active disease present for more than 3 years. Individual may be receiving adjuvant hormonal therapy