A Study of Tacabrutideg (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
18 Years and older, Male and Female
BGB-16673-302 (primary)
NCI-2025-07449
2024-518893-15-00
Summary
The purpose of this study is to investigate the efficacy and safety of tacabrutideg
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).
Objectives
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 tacabrutideg 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 tacabrutideg 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 tacabrutideg or the
investigator's choice of treatment.
"Our company, previously known as BeiGene, is now officially BeOne Medicines. Because
some of our older studies were sponsored under the name BeiGene, you may see both names
used for this study on this website."
Eligibility
- 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
Treatment Sites in Georgia
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