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

BeOne Medicines

Status and phase: Enrolling; Phase 3

Conditions: Small Lymphocytic Lymphoma; Chronic Lymphocytic Leukemia

Treatments: Drug: Pirtobrutinib; Drug: BGB-16673

Study type: Interventional

Funder types: Industry

Identifiers

NCT06973187

BGB-16673-304

2025-522860-34-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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).

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Arm A: BGB-16673

Experimental group

Description:

Participants will receive BGB-16673 orally.

Treatment:

Drug: BGB-16673

Arm B: Pirtobrutinib

Active Comparator group

Description:

Participants will receive pirtobrutinib orally.

Treatment:

Drug: Pirtobrutinib