Status:
RECRUITING
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
Lead Sponsor:
BeOne Medicines
Conditions:
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 smal...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 17 2028
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06973187
Start Date
September 4 2025
End Date
April 17 2028
Last Update
December 23 2025
Active Locations (39)
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1
Cancer Specialists of North Florida
Jacksonville, Florida, United States, 001625
2
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140-2840
3
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809-3738
4
Washington University School of Medicine
St Louis, Missouri, United States, 63110-1010