Pirtobrutinib (LOXO-305) and Venetoclax for the Treatment of Patients With CLL or SLL Resistant to Covalent BTKi

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKerry Rogers

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

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

Kerry Rogers

Lead sponsor

Ohio State University Comprehensive Cancer Center

Sponsor institution