drugset / Trial / NCT06588478

A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

NCT06588478

Phase 2 Recruiting 249 enrolled Loxo Oncology, Inc. Eli Lilly and Company · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The main purpose of Part 1 of this study is to assess the efficacy and safety of 3 dose levels of Pirtobrutinib in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have received 1-3 lines of treatment including a covalent Bruton tyrosine kinase (BTK) inhibitor. The purpose of Part 2 of this study is to evaluate pirtobrutinib monotherapy in participants with treatment-naïve CLL/SLL with 17p deletions. Participation in Part 1 is expected to last approximately 3 years. Participation in Part 2 is expected to last up to 2 years.

Timeline

Start
2025-01-03
Primary completion
2028-06
Completion
2028-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Pirtobrutinib Other / unclassified Oral