Study of LOXO-305 Versus Investigator's Choice (IdelaR or BR) in Patients With CLL or SLL

Official 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)

Summary:

This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress.

Trial Description

Primary Outcome:

• To evaluate progression-free survival (PFS) of LOXO-305 monotherapy (Arm A) compared to investigator's choice of idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR) (Arm B)

Secondary Outcome:

• To evaluate the effectiveness of Arm A compared to Arm B based on Overall Response Rate (ORR)
• To evaluate the effectiveness of Arm A compared to Arm B based on Overall Survival (OS)
• To evaluate the effectiveness of Arm A compared to Arm B based on Time to Next Treatment (TTNT)
• Time to worsening (TTW) of CLL/SLL related symptoms
• Time to worsening (TTW) of physical function

This is a Phase 3 global, randomized, open-label study comparing LOXO-305 (Arm A) to investigator's choice of either idelalisib plus rituximab or bendamustine plus rituximab (Arm B) in CLL/SLL patients who have been treated with at least a covalent BTK inhibitor (BTKi). Patients may have discontinued the prior covalent BTKi due to disease progression (PD) or intolerance. Patients who have received venetoclax are eligible for the study. Eligible patients will be randomized in 1:1 to Arm A and Arm B.

View this trial on ClinicalTrials.gov