RecruitingChronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

A Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Eligible age

18+ yrs

Accepts

All genders

Locations

24 states

Healthy volunteers

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About this study

The purpose of this study is to evaluate the efficacy and safety of BGB-16673 alone compared with pirtobrutinib in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had been previously treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi).

Sponsor: BeOne Medicines

You may qualify if…

✓ Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 iwCLL criteria
✓ Previously received treatment for CLL/SLL with a covalent Bruton tyrosine kinase inhibitor (cBTKi). Patients should have disease relapsed after or refractory to at least 1 line of therapy including a cBTKi.
✓ Participants with SLL must have measurable disease by computed tomography/magnetic resonance imaging, defined as ≥ 1 lymph node \> 1.5 cm in longest diameter and measurable in 2 perpendicular diameters.

You may not qualify if…

✕ Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation.
✕ History of known bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention
✕ History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug
✕ Prior exposure to any Bruton tyrosine kinase (BTK) protein degraders or noncovalent Bruton tyrosine kinase inhibitor (ncBTKi).
✕ Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by CLL/SLL
✕ NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.