A Study of 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

Recruiting now · Phase 3

Conditions studied: CLL, Chronic Lymphocytic Leukemia

In brief

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).

Key facts

Study ID

NCT06846671

Run by

BeOne Medicines

People needed

250

Starts

2025-04-10

Expected to finish

2030-02-14

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
• Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 months
• Known central nervous system involvement
• Prior exposure to any BTK protein degraders
• Active fungal, bacterial and/or viral infection requiring parenteral systemic therapy
• Clinically significant cardiovascular disease
• NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Where it is running

• UCLA Department of Medicine Hematologyoncology — Los Angeles, California, United States (enrolling)
• Pih Health Whittier Hospital — Whittier, California, United States (enrolling)
• Rocky Mountain Cancer Centers (Williams) Usor — Aurora, Colorado, United States (enrolling)
• Florida Oncology and Hematology — Fort Myers, Florida, United States (enrolling)
• Baptist Md Anderson Cancer Center — Jacksonville, Florida, United States (enrolling)
• Cleveland Clinic Florida — Weston, Florida, United States (enrolling)
• Emory University Winship Cancer Institute — Atlanta, Georgia, United States (enrolling)
• Northside Cancer Center — Atlanta, Georgia, United States (enrolling)
• Our Lady of the Lake Hospital — Baton Rouge, Louisiana, United States (enrolling)
• American Oncology Partners of Maryland Pa — Bethesda, Maryland, United States (enrolling)
• Corewell Health the Michigan Cancer Consortium — Grand Rapids, Michigan, United States (enrolling)
• St Lukes Center For Cancer Care — Chesterfield, Missouri, United States (enrolling)
• Oncology Hematology Associates — Springfield, Missouri, United States (enrolling)
• St Vincent Frontier Cancer Center — Billings, Montana, United States (enrolling)
• Oncology Hematology West, Pc Dba Nebraska Cancer Specialists — Omaha, Nebraska, United States (enrolling)
• Memorial Sloan Kettering Cancer Center Mskcc — New York, New York, United States (enrolling)
• New York Cancer and Blood Specialists — Shirley, New York, United States (enrolling)
• Optum Medical Care, Pc — Westbury, New York, United States (enrolling)
• University Hospitals — Cleveland, Ohio, United States (enrolling)
• Dayton Physician Network — Dayton, Ohio, United States (enrolling)
• Oncology Associates of Oregon Willamette Valley Cancer Center — Eugene, Oregon, United States (enrolling)
• West Penn Hospital — Pittsburgh, Pennsylvania, United States (enrolling)
• Cancer Care Associates of York — York, Pennsylvania, United States (enrolling)
• Texas Oncology Tyler — Tyler, Texas, United States (enrolling)
• St Bernards Medical Center — Jonesboro, Arkansas, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.