Clinical Trial

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)

Study acronym: BRUIN CLL-322
Active, Not Recruiting Phase 3
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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.
Protocol Amendment History 29 amendments
This ClinicalTrials.gov record has been amended 29 times since 2021-07-15; most recent amendment 2026-01-27.
Status change: Recruiting → Active, Not Recruiting 2024-11-15
Status change: Not Yet Recruiting → Recruiting 2021-10-11
Trial Details
NCT Number NCT04965493
Lead Sponsor Loxo Oncology, Inc.
Collaborators: Eli Lilly and Company
Conditions Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Enrollment 600 participants
Start Date 2021-09-20
Primary Completion 2026-10 (estimated)
Study Completion 2027-10 (estimated)
Updated on ClinicalTrials.gov 2026-01-29