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
Sponsor: BeOne Medicines
ClinicalTrials ID:NCT06973187
This study assesses the safety and efficacy of BGB-16673 versus pirtobrutinib in adults with R/R CLL or SLL. Eligible participants must have a confirmed CLL/SLL diagnosis, prior cBTKi treatment, and measurable disease for SLL. Both drugs are administered orally.
Patient Parameters
| Parameter | Options |
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Program Overview
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 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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Cancer Specialists of North Florida | 001625 | Jacksonville | Florida |
| Washington University School of Medicine | 63110-1010 | St Louis | Missouri |
| Dayton Physician Network | 45415 | Dayton | Ohio |
| Blue Ridge Cancer Care (Oncology and Hematology Associates of Southwest Virginia) | 24014 | Roanoke | Virginia |
| Summit Cancer Centers | 99208-1129 | Spokane | Washington |
| Northwest Medical Specialties | 98405 | Tacoma | Washington |
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