Title: A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (BRUIN CLL-313)
Study Director: Safi Shahda, Loxo Oncology, Inc.
Description: Researchers are conducting a phase 3 trial to compare the efficacy and safety of pirtobrutinib with bendamustine plus rituximab (BR) in patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
Patients will be randomly assigned 1:1 to oral pirtobrutinib or intravenous BR. Patients in the BR arm who have disease progression confirmed by an independent review committee may be eligible to cross over to the pirtobrutinib arm.
The primary outcome measure of the study is progression-free survival (PFS) by independent review. Key secondary endpoints include investigator-assessed PFS, overall survival, time to next treatment, overall response rate, duration of response, and patient-reported outcomes.
To be eligible, patients must have a diagnosis of CLL/SLL requiring therapy, as per International Workshop on Chronic Lymphocytic Leukemia 2018 criteria. Patients must also be 18 years of age or older, have adequate organ function, and have a performance status of 0 to 2. For a complete list of eligibility criteria, please refer to the reference.
This study is sponsored by Loxo Oncology, Inc.
Clinicaltrials.gov. A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (BRUIN CLL-313). NCT05023980. Accessed October 20, 2021.