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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

NCT06973187

RecruitingPhase 3

Sponsor: BeOne Medicines

Conditions: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Interventions: BGB-16673, Pirtobrutinib

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, China, France

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Locations (204)

Birmingham, Alabama, United States
Phoenix, Arizona, United States
Irvine, California, United States
La Jolla, California, United States
Los Alamitos, California, United States
Los Angeles, California, United States
Oakland, California, United States
Palo Alto, California, United States
Roseville, California, United States
San Francisco, California, United States
Santa Clara, California, United States
Vallejo, California, United States
Walnut Creek, California, United States
Newark, Delaware, United States
Washington D.C., District of Columbia, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Chicago, Illinois, United States
Waukee, Iowa, United States
Westwood, Kansas, United States
Baton Rouge, Louisiana, United States
Baton Rouge, Louisiana, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Rochester, Minnesota, United States
St Louis, Missouri, United States
East Brunswick, New Jersey, United States
Hackensack, New Jersey, United States
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