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

Overview

About this study

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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Eligibility last updated 10/14/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Ricardo Parrondo

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Lindsey Roeker

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Talal Hilal

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20597332

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