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

Recruiting now · Phase 3

Conditions studied: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

In brief

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).

Key facts

Study ID

NCT06973187

Run by

BeOne Medicines

People needed

500

Starts

2025-09-04

Expected to finish

2028-04-17

Last updated by the study team

2026-08-06

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 iwCLL criteria
• Previously received treatment for CLL/SLL with a covalent Bruton tyrosine kinase inhibitor (cBTKi). Patients should have disease relapsed after or refractory to at least 1 line of therapy including a cBTKi.
• Participants with SLL must have measurable disease by computed tomography/magnetic resonance imaging, defined as ≥ 1 lymph node > 1.5 cm in longest diameter and measurable in 2 perpendicular diameters.

You may not qualify if…

• Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation.
• History of known bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention
• History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug
• Prior exposure to any Bruton tyrosine kinase (BTK) protein degraders or noncovalent Bruton tyrosine kinase inhibitor (ncBTKi).
• Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by CLL/SLL
• NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Where it is running

• Mayo Clinic Phoenix — Phoenix, Arizona, United States (enrolling)
• Kaiser Permanente Southern California — Irvine, California, United States (enrolling)
• University of California San Diego (Ucsd) Moores Cancer Center — La Jolla, California, United States (enrolling)
• Cancer and Blood Specialty Clinic — Los Alamitos, California, United States (enrolling)
• UCLA Department of Medicine Hematologyoncology — Los Angeles, California, United States (enrolling)
• Kaiser Permanente Oakland Medical Center — Oakland, California, United States (enrolling)
• Stanford Cancer Institute — Palo Alto, California, United States (enrolling)
• Kaiser Permanente Roseville Medical Center — Roseville, California, United States (enrolling)
• Kaiser Permanente San Francisco Medical Center Oncology — San Francisco, California, United States (enrolling)
• Kaiser Permanente Santa Clara Medical Center Oncologyhematology — Santa Clara, California, United States (enrolling)
• Kaiser Permanente Northern California — Vallejo, California, United States (enrolling)
• Kaiser Permanente Walnut Creek Medical Center — Walnut Creek, California, United States (enrolling)
• Christiana Care — Newark, Delaware, United States (enrolling)
• Medstar Georgetown University Hospital — Washington D.C., District of Columbia, United States (enrolling)
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States (enrolling)
• Cancer Specialists of North Florida — Jacksonville, Florida, United States (enrolling)
• Mount Sinai Medical Center Braman Comprehensive Cancer Center — Miami, Florida, United States (enrolling)
• University of Chicago Medical Center — Chicago, Illinois, United States (enrolling)
• Mission Cancer and Blood — Waukee, Iowa, United States (enrolling)
• The University of Kansas Cancer Center — Westwood, Kansas, United States (enrolling)
• Our Lady of the Lake Hospital — Baton Rouge, Louisiana, United States (enrolling)
• Mary Bird Perkins Cancer Center — Baton Rouge, Louisiana, United States (enrolling)
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• University of Alabama At Birmingham Hospital — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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