OncRef

Clinical Trial: NCT04965493

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)

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:Loxo Oncology, Inc.
Information Provided By:Eli Lilly and Company
Last Update Posted:2026-01-29

Study Overview

Brief 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.

Official Title

A Phase 3 Open-Label, Randomized Study of Fixed Duration Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab Versus Venetoclax and Rituximab in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-322)

Conditions

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Intervention / Treatment

  • Drug: Pirtobrutinib
  • Drug: Venetoclax
  • Drug: Rituximab

Other Study ID Numbers

  • 18087
  • J2N-OX-JZNO
  • LOXO-BTK-20022

Start Date (Actual)

2021-09-20

Primary Completion Date (Estimated)

2026-10

Study Completion Date (Estimated)

2027-10

Enrollment (Estimated)

600

Study Type

Interventional

Phase

Phase 3