A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Summary

The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.

Timeline

Start

2021-09-20

Primary completion

2026-10

Completion

2027-10

Publications

• Davids MS, Eyre TA, Woyach JA, Roeker LE, Ferrajoli A, Wang Y, Tam CS, Jurczak W, Zinzani PL, Simkovic M, Li JY, Bosch F, Roos-Weil D, Cramer P, Osterborg A, Islam P, Jacobs R, Skarbnik A, Bhat SA, Kang S, Chen M, Nguyen B, McNeely SC, Chung KL, Oliveira JM, Ito R, Ghia P, Wierda WG. Fixed-duration pirtobrutinib plus venetoclax-rituximab versus venetoclax-rituximab for patients with previously treated chronic lymphocytic leukaemia or small lymphocytic lymphoma (BRUIN CLL-322): an open-label, multicentre, randomised, controlled, phase 3 trial. Lancet. 2026 Jul 9:S0140-6736(26)01204-3. doi: 10.1016/S0140-6736(26)01204-3. Online ahead of print.

Drugs

Indications