A Phase 3 Open-Label, Randomized Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Trial Description
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).
Eligibility Requirements
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.