NCT06970743

A Study of BGB-16673 Compared to Investigator's Choice in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent Bruton Tyrosine Kinase (BTK) Inhibitors

A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator's Choice in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent BTK Inhibitors

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: BeOne Medicines · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the efficacy and safety of BGB-16673 compared with investigator's choice (bendamustine plus rituximab or high-dose methylprednisolone plus rituximab) in participants with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to covalent Bruton tyrosine kinase inhibitor(s) (cBTKi).

Detailed description

Chronic lymphocytic leukemia and small lymphocytic lymphoma are types of blood cancer that affects people around the world. People with CLL and SLL 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 R/R CLL or SLL who were previously exposed to a covalent BTKi will receive BGB-16673 or the investigator's choice of bendamustine plus rituximab or high-dose methylprednisolone plus rituximab. 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. Approximately 150 participants will be included in this study in Mainland China and Taiwan. Participants will be randomly allocated to receive either BGB-16673 or the investigator's choice of treatment.

Conditions

• Chronic Lymphocytic Leukemia
• Small Lymphocytic Lymphoma

Interventions

Type	Name	Description
DRUG	BGB-16673	Administered orally
DRUG	Bendamustine	Administered intravenously
DRUG	Rituximab	Administered intravenously
DRUG	Methylprednisolone	Administered intravenously

Timeline

• Start date: 2025-05-29
• Primary completion: 2029-11-30
• Completion: 2029-11-30
• First posted: 2025-05-14
• Last updated: 2026-01-07

Locations

64 sites across 2 countries: China, Taiwan