Title: A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator’s Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-321)

Study Director: Safi Shahda, MD, Loxo Oncology

Description: Researchers are conducting a phase 3 global, randomized, open-label study comparing LOXO-305 to investigator’s choice of either idelalisib plus rituximab or bendamustine plus rituximab in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have been treated with at least a covalent Bruton tyrosine kinase inhibitor (BTKi). Patients may have discontinued the prior covalent BTKi due to disease progression or intolerance. The primary outcome measure of the trial is to evaluate progression-free survival after LOXO-305 monotherapy compared to investigator’s choice.

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Status: Recruiting

This study is sponsored by Loxo Oncology, Inc.


Clinicaltrials.gov. Study of LOXO-305 Versus Investigator’s Choice (IdelaR or BR) in Patients With CLL or SLL. NCT04666038. Accessed April 23, 2021.