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).
Additional locations may be listed on ClinicalTrials.gov for NCT06846671.
See trial information on ClinicalTrials.gov for a list of participating sites.
Chronic lymphocytic leukemia is a type of blood cancer that affects people around the
world. People with CLL suffer from enlarged lymph nodes, spleen, or liver, or have
symptoms like night sweats, weight loss and fever. They have shorter life expectancy
compared to healthy people. There is an urgent need for new treatment to prolong life and
control disease-related symptoms.
In this study, participants with relapsed/refractory (R/R) CLL who were previously
exposed to a BTKi and a BCL2i will receive BGB-16673 or the investigator's choice of
idelalisib plus rituximab (for CLL only) or bendamustine plus rituximab or venetoclax
plus rituximab retreatment. The main purpose of this study is to compare the length of
time that participants live without their CLL or SLL worsening between those participants
who receive BGB-16673 versus the investigator's choice of treatment (idelalisib plus
rituximab or bendamustine plus rituximab, or venetoclax plus rituximab).
Approximately 250 participants will be included in this study around the world.
Participants will be randomly allocated to receive either BGB-16673 or the investigator's
choice of treatment.
Lead OrganizationBeiGene Company Limited
