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A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors
Trial Status: active
The purpose of this study is to investigate the efficacy and safety of BGB-16673 compared
with investigator's choice (idelalisib plus rituximab [for CLL only] or bendamustine plus
rituximab or venetoclax plus rituximab retreatment) in participants with chronic
lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to both
BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).
Inclusion Criteria
Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.
Previously received treatment for CLL/SLL with both a BTKi and a BCL2i.
Participants with SLL must have measurable disease by computer tomography (CT)/magnetic resonance imaging (MRI)
Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
Adequate liver function
Adequate blood clotting function
Exclusion Criteria
Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 months
Known central nervous system involvement
Prior exposure to any BTK protein degraders
Active fungal, bacterial and/or viral infection requiring parenteral systemic therapy
Clinically significant cardiovascular disease NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06846671.