drugset
drugset / Trial / NCT04666038

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)

NCT04666038 ↗

Phase 3 Active not recruiting 238 enrolled Loxo Oncology, Inc. Eli Lilly and Company · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2021-03-09
Primary completion
2023-08-29
Completion
2027-05

Outcome

Met primary endpoint

paper The primary PFS end point was met at the time of the primary analysis (August 29, 2023) PMID 40479620 ↗

registry p = 0.0002; Hazard Ratio (HR) 0.536 (95% CI 0.385 to 0.746) NCT04666038 ↗

release “BRUIN CLL-321, which previously met its primary endpoint, is the first randomized Phase 3 study” lilly.com ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bendamustine Small molecule 70 mg/m2 Intravenous
Comparator Idelalisib Small molecule 150 mg Oral
Subject Pirtobrutinib Small molecule 200 mg Oral
Comparator Rituximab Monoclonal antibody 500 mg/m2 Intravenous

Indications

chronic lymphocytic leukemia/small lymphocytic lymphoma