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PIPELINE > TRIAL OVERVIEW

Trial Information
Molecule Overview
BTK Inhibitor
Pirtobrutinib
Phase
2
Recruiting
Recruiting Info
A Phase 2, Open-Label, Randomized Study Evaluating Efficacy and Safety of 3 Doses of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Who Previously Received Treatment With a Covalent Bruton Tyrosine Kinase Inhibitor
Related Resources:
BRUIN CLL-211
Key Inclusion Criteria
  • Confirmed chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and in need of treatment defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria
  • Part 1: Received at least 1, but not more than 3, lines of prior treatment for CLL/SLL
  • Received a covalent Bruton's tyrosine kinase (BTK) inhibitor
  • Part 2: Received no prior treatment for CLL/SLL
    • Part 1: Known 17p deletion status (positive or negative)
    • Part 2: Must have 17p deletion (positive)
  • Capable of swallowing oral study medication
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
Key Exclusion Criteria
  • Received prior treatment with a BTK degrader or a non-covalent BTK inhibitor 
  • History of ≥ Grade 3 bleeding due to treatment with a BTK inhibitor
  • Known or suspected Richter's transformation
  • Known or suspected history of central nervous system involvement by CLL/SLL
  • Previous or concurrent cancer distinct from CLL/SLL within 3 years before randomization. Exceptions may occur with documented sponsor approval. Examples include:
    • Nonmelanoma skin cancer or lentigo malignant melanoma
    • Cervical carcinoma in situ
    • Localized prostate cancer undergoing active surveillance
    • Localized (for example, lymph node negative) breast cancer with no evidence of active disease for >3 years. Individual may be receiving adjuvant hormonal therapy
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Pirtobrutinib is administered orally.
For information on trial enrollment, locations, and more, call 1-800-545-5979.
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