A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

The purpose of Part 1 of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL; participants may or may not have already had treatment for their cancer. The purpose of Part 2 of this study evaluates pirtobrutinib monotherapy in treatment-naïve participants with CLL/SLL with 17p deletions. Participation could last up to six years for Part 1. Participation could last up to 2 years for Part 2.

Trial Details

NCT ID
NCT05254743
Phase
PHASE3
Sponsor
Loxo Oncology, Inc.
Status
RECRUITING
Cancer Type
Non-Hodgkin Lymphoma Lymphoma
Interventions
  • Pirtobrutinib
  • Ibrutinib
Locations (sample)
  • Anaheim, California, United States|33.83529,-117.9145
  • Cerritos, California, United States|33.85835,-118.06479
  • Palo Alto, California, United States|37.44188,-122.14302
  • San Marcos, California, United States|33.14337,-117.16614
  • Fort Myers, Florida, United States|26.62168,-81.84059

Key Eligibility Criteria

  • Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
  • Part 1 - Known 17p deletion status (wildtype or deleted). Part 2 - Must have deletion of 17p as determined by FISH testing
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • Adequate organ function

For full eligibility, visit ClinicalTrials.gov.

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