OncRef

Clinical Trial: NCT05023980

A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With 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:2026-09-25

Study Overview

Brief Summary

The purpose of this study is to compare the efficacy and safety of pirtobrutinib (LOXO-305; Arm A) compared to BR (Arm B) in patients with CLL/SLL who have not been treated. Participation could last up to five years.

Official Title

A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Conditions

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Intervention / Treatment

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

Other Study ID Numbers

  • 18088
  • J2N-OX-JZNP
  • LOXO-BTK-20023
  • 2024-511599-33-00

Start Date (Actual)

2021-09-23

Primary Completion Date (Actual)

2025-07-11

Study Completion Date (Estimated)

2027-10

Enrollment (Actual)

282

Study Type

Interventional

Phase

Phase 3