This study involves patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, which are types of blood cancers that affect white blood cells and can also involve the lymph nodes. These conditions belong to a group of cancers where abnormal white blood cells build up in the blood, bone marrow, and lymph nodes. The study compares two medications: BGB-16673, which is an investigational drug being tested, and pirtobrutinib, which is an approved medication. Both drugs are given as tablets that are taken by mouth. The study focuses on patients whose disease has come back after previous treatment or did not respond to earlier treatment that included a specific type of medication called a covalent Bruton tyrosine kinase inhibitor.
The purpose of the study is to compare how well BGB-16673 works against pirtobrutinib in controlling the disease and to evaluate the safety of both treatments. The study will measure how long patients live without their disease getting worse, which is called progression-free survival. This will be assessed by an independent group of medical experts who will review imaging scans and other test results. The study will also look at overall survival, which means how long patients live overall, and will measure how many patients respond to treatment by having their disease shrink or disappear. Additional measurements include how long the treatment response lasts and how long it takes before patients need another treatment for their disease.
During the study, patients will be randomly assigned to receive either BGB-16673 or pirtobrutinib. Both groups will continue taking their assigned medication for up to 42 months unless their disease gets worse or they experience unacceptable side effects. The study will monitor patients for any unwanted effects of the medications and will track how severe these effects are. Patients will also complete questionnaires about their quality of life, including questions about their physical functioning, symptoms, and overall health status. The study will use computed tomography or magnetic resonance imaging scans to measure disease in patients with small lymphocytic lymphoma, looking for lymph nodes that are larger than normal size.



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