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

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.

Trial Details

NCT ID
NCT06588478
Phase
PHASE2
Sponsor
Loxo Oncology, Inc.
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • Pirtobrutinib
Locations (sample)
  • Chandler, Arizona, United States|33.30616,-111.84125
  • Duarte, California, United States|34.13945,-117.97729
  • Irvine, California, United States|33.66946,-117.82311
  • Palo Alto, California, United States|37.44188,-122.14302
  • Palo Alto, California, United States|37.44188,-122.14302

Key Eligibility Criteria

  • Have confirmed diagnosis of CLL/SLL as defined by iwCLL 2018 criteria.
  • Part 1: Have received prior CLL/SLL treatment
  • Have received at least 1, but not more than 3 lines of prior treatment for CLL/SLL
  • Have received a covalent BTK inhibitor

For full eligibility, visit ClinicalTrials.gov.

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