OncRef

Clinical 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)

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:Loxo Oncology, Inc.
Information Provided By:Eli Lilly and Company
Last Update Posted:2026-04-24

Study Overview

Brief 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.

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)

Conditions

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Intervention / Treatment

  • Drug: Pirtobrutinib
  • Drug: Idelalisib
  • Drug: Bendamustine
  • Drug: Rituximab

Other Study ID Numbers

  • 18073
  • J2N-OX-JZNN
  • LOXO-BTK-20020

Start Date (Actual)

2021-03-09

Primary Completion Date (Actual)

2023-08-29

Study Completion Date (Estimated)

2027-05

Enrollment (Actual)

238

Study Type

Interventional

Phase

Phase 3