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...
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...
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
March 5 2026
Active Locations (126)
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1
Mayo Clinic Phoenix
Phoenix, Arizona, United States, 85054-4502
2
University of California San Diego (Ucsd) Moores Cancer Center
La Jolla, California, United States, 92093-1503
3
UCLA Department of Medicine Hematologyoncology
Los Angeles, California, United States, 90095-3075
4
Stanford Cancer Institute
Palo Alto, California, United States, 94304-2205