About this trial
This phase II trial tests how well pirtobrutinib (LOXO-305) and venetoclax works in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that remains despite treatment (resistant) with covalent bruton tyrosine kinase inhibitors (BTKi). Pirtobrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the a protein that signals cancer cells to multiply. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Giving pirtobrutinib and venetoclax may kill more cancer cells in patients with CLL or SLL that is resistant to covalent BTKi.
Eligibility criteria
Qualifiers
Diagnosis of CLL or SLL according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 guidelines
Detectable CLL on flow cytometry of the blood or marrow at time of enrollment
Age ≥ 18 years old
Eastern Cooperative Oncology Group (ECOG) performance 0-2
Disqualifiers
Inability to tolerate 2 Liters of oral or intravenous (IV) hydration
Prior venetoclax exposure > 13 months or known resistance to venetoclax
Known hypersensitivity to any of the excipients of pirtobrutinib or venetoclax
Need for treatment with warfarin or other vitamin K antagonist during study treatment
Trial design
Treatments tested in this trial
- Biospecimen Collection
- Bone Marrow Aspiration
- Bone Marrow Biopsy
- Computed Tomography
- Pirtobrutinib
- Venetoclax
Treatment groups
Sponsors and collaborators
Kerry Rogers
Lead sponsor
Ohio State University Comprehensive Cancer Center
Sponsor institution