NCT06973187

A Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

A Phase 3, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: BeOne Medicines · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of BGB-16673 alone compared with pirtobrutinib in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had been previously treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi).

Detailed description

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.

Conditions

• Chronic Lymphocytic Leukemia
• Small Lymphocytic Lymphoma

Interventions

Type	Name	Description
DRUG	BGB-16673	BGB-16673 will be administered orally
DRUG	Pirtobrutinib	Pirtobrutinib will be administered orally

Timeline

• Start date: 2025-09-04
• Primary completion: 2028-04-17
• Completion: 2028-04-17
• First posted: 2025-05-15
• Last updated: 2026-04-15

Locations

143 sites across 21 countries: United States, Australia, Austria, Belgium, Brazil, France, Germany, Israel, Italy, Japan, Netherlands, New Zealand, Poland, Puerto Rico, Romania, Singapore, South Korea, Spain, Sweden, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study