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

Active:	Yes
Cancer Type:	Leukemia	NCT ID:	NCT06846671
Trial Phases:	Phase III	Protocol IDs:	BGB-16673-302 (primary) NCI-2025-07449 2024-518893-15-00
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	BeOne Medicines
NCI Full Details:	http://clinicaltrials.gov/show/NCT06846671

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."

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.