A Phase 3 Open-Label, Randomized Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

ENROLLING
Protocol # :
25-777
Conditions
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Phase
III
Disease Sites
Lymphoid Leukemia
Principal Investigator
Ahn, Inhye
Site Research Nurses
Ali, Ijaabo
Cyr, Virgina, Brigham
Kats, Vanessa
Mezitt, Anna
Normilus, Samantha
Patterson, Victoria

Trial Description

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 Requirements

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.

25-777