Study on the Safety and Effectiveness of BGB-16673 Compared to Pirtobrutinib in Adults with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Sponsor: BeOne Medicines
ClinicalTrials ID:NCT06973187
This clinical trial is testing a new drug, BGB-16673, to see if it is safe and effective compared to another drug, pirtobrutinib, in adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has returned or not responded to previous treatments.
Patient Parameters
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Program Overview
The aim of this study is to compare the effectiveness and safety of a new treatment, BGB-16673, with an existing treatment, pirtobrutinib, in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has come back or not responded to previous treatments. Participants must have previously been treated with a specific type of medication called a covalent Bruton tyrosine kinase inhibitor (cBTKi).
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that requires treatment.
- Have previously been treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi) and have the disease return or not respond to at least one line of therapy, including a cBTKi.
- For those with SLL, have measurable disease on scans, with at least one lymph node larger than 1.5 cm in diameter.
Exclusion Criteria
- Have a known type of leukemia called prolymphocytic leukemia or a history of, or currently suspected, transformation to a more aggressive form known as Richter's transformation.
- Have a history of bleeding disorders like hemophilia or von Willebrand disease, or have experienced spontaneous bleeding that required medical treatment.
- Have had a stroke or bleeding in the brain within the last 6 months.
- Have previously been treated with any Bruton tyrosine kinase (BTK) protein degraders or noncovalent Bruton tyrosine kinase inhibitors (ncBTKi).
- Have current or past involvement of the central nervous system (brain, spinal cord, or surrounding areas) by CLL/SLL, as shown by imaging or tests.
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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