A Study of BGB-16673 Compared to Investigator's Choice in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent Bruton Tyrosine Kinase (BTK) Inhibitors

Launched by BEIGENE · May 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BGB-16673 for patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). These are types of blood cancers that can come back or do not respond to previous treatments. The goal is to see if BGB-16673 is more effective and safer than standard treatment options, which include combinations of bendamustine and rituximab or high-dose methylprednisolone and rituximab. The trial is currently not yet recruiting participants.

To be eligible for the study, you must have a confirmed diagnosis of CLL or SLL that needs treatment and have previously been treated with a specific type of medication called a covalent BTK inhibitor. Other important criteria include having measurable disease, good overall health, and proper functioning of your bone marrow, kidneys, and liver. Participants can expect to receive either the new treatment or the standard treatment as part of the study. If you decide to join, you will be monitored closely for any side effects or changes in your condition throughout the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Confirmed diagnosis of CLL/SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.
• • 2. Previously received treatment for CLL/SLL with a covalent BTKi.
• • 3. Measurable disease by computer tomography/magnetic resonance imaging for patients with SLL.
• • 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• • 5. Adequate bone marrow function
• • 6. Adequate kidney and liver function
• • 7. Adequate blood clotting function
• Exclusion Criteria:
• • 1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
• • 2. 2. Prior autologous stem cell transplant (unless ≥ 3 months after transplant) or chimeric antigen receptor-T cell (unless ≥ 6 months after cell infusion)
• • 3. History of severe allergic reactions or hypersensitivity to the active ingredient and excipients of study treatment (BGB-16673, bendamustine, or rituximab)
• • 4. Current or history of central nervous system involvement
• • 5. History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug
• • 6. History of confirmed progressive multifocal leukoencephalopathy.
• • 7. Active fungal, bacterial, and/or viral infection requiring parenteral systemic therapy
• • 8. Clinically significant cardiovascular disease
• • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.