Clinical Trial

Study of LOXO-305 (Pirtobrutinib) Versus Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Study acronym: BRUIN CLL-321
Active, Not Recruiting Phase 3
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Summary
This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (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.
Protocol Amendment History 35 amendments
This ClinicalTrials.gov record has been amended 35 times since 2020-12-07; most recent amendment 2026-04-07.
Status change: Recruiting → Active, Not Recruiting 2024-04-24
Status change: Not Yet Recruiting → Recruiting 2021-04-01
Trial Details
NCT Number NCT04666038
Lead Sponsor Loxo Oncology, Inc.
Collaborators: Eli Lilly and Company
Conditions Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Enrollment 238 participants
Start Date 2021-03-09
Primary Completion 2023-08-29 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2026-04-24