ClinicalTrials.gov ID:  NCT06973187
Investigator: Shazia K. Nakhoda, MD
Protocol: 25-1051
Phase: III
Diseases: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

This is a multicenter randomized control trial evaluating novel BTK degrader (BGB-16673) versus standard of care pirtobrutinib in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had progressive disease on a prior line containing a covalent Bruton tyrosine kinase inhibitor (cBTKi). Patient are allowed but not required to have previously received venetoclax (or other BCL2 directed therapy). 

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 > or = 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 disorders 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

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