OncRef

Clinical Trial: NCT03740529

A Study of Oral LOXO-305 in Patients With Previously Treated CLL/SLL or NHL

Status:

COMPLETED

Phase:

Phase 1

Lead Sponsor:Loxo Oncology, Inc.
Information Provided By:Eli Lilly and Company
Last Update Posted:2026-01-27

Study Overview

Brief Summary

This is an open-label, multi-center Phase 1/2 study of oral LOXO-305 (pirtobrutinib) in patients with CLL/SLL and NHL who have failed or are intolerant to standard of care.

Official Title

A Phase 1/2 Study of Oral LOXO-305 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin Lymphoma (NHL)

Conditions

Chronic Lymphocytic Leukemia, Waldenstrom Macroglobulinemia, Mantle Cell Lymphoma, Marginal Zone Lymphoma, B-cell Lymphoma, Small Lymphocytic Lymphoma

Intervention / Treatment

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

Other Study ID Numbers

  • 17539
  • 2018-003340-24
  • J2N-OX-JZNA
  • LOXO-BTK-18001 (BRUIN)
  • 2018

Start Date (Actual)

2019-03-15

Primary Completion Date (Actual)

2025-01-27

Study Completion Date (Actual)

2025-12-23

Enrollment (Actual)

803

Study Type

Interventional

Phase

Phase 1, Phase 2