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

Last updated: May 15, 2025
Sponsor: BeiGene
Overall Status: Active - Not Recruiting

Phase

3

Condition

Leukemia

Lymphocytic Leukemia, Chronic

Leukemia (Pediatric)

Treatment

Methylprednisolone

BGB-16673

Rituximab

Clinical Study ID

NCT06970743
BGB-16673-303
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to investigate the efficacy and safety of BGB-16673 compared with investigator's choice (bendamustine plus rituximab or high-dose methylprednisolone plus rituximab) in participants with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to covalent Bruton tyrosine kinase inhibitor(s) (cBTKi).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Confirmed diagnosis of CLL/SLL, requiring treatment, based on 2018 internationalworkshop 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 patientswith 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

Exclusion Criteria:

  1. Known prolymphocytic leukemia or history of, or currently suspected, Richter'stransformation

  3. Prior autologous stem cell transplant (unless ≥ 3 months after transplant) orchimeric antigen receptor-T cell (unless ≥ 6 months after cell infusion)

  4. History of severe allergic reactions or hypersensitivity to the active ingredientand excipients of study treatment (BGB-16673, bendamustine, or rituximab)

  5. Current or history of central nervous system involvement

  6. History of ischemic stroke or intracranial hemorrhage within 6 months before firstdose of study drug

  7. History of confirmed progressive multifocal leukoencephalopathy.

  8. Active fungal, bacterial, and/or viral infection requiring parenteral systemictherapy

  9. Clinically significant cardiovascular disease

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 150
Treatment Group(s): 4
Primary Treatment: Methylprednisolone
Phase: 3
Study Start date:
June 02, 2025
Estimated Completion Date:
November 30, 2029

Study Description

Chronic lymphocytic leukemia and small lymphocytic lymphoma are types of blood cancer that affects people around the world. People with CLL and SLL suffer from enlarged lymph nodes, spleen, or liver, or have symptoms like night sweats, weight loss and fever. They have shorter life expectancy compared to healthy people. There is an urgent need for new treatment to prolong life and control disease-related symptoms.

In this study, participants with R/R CLL or SLL who were previously exposed to a covalent BTKi will receive BGB-16673 or the investigator's choice of bendamustine plus rituximab or high-dose methylprednisolone plus rituximab. The main purpose of this study is to compare the length of time that participants live without their CLL or SLL worsening between those participants who receive BGB-16673 versus the investigator's choice of treatment. Approximately 150 participants will be included in this study in Mainland China and Taiwan. Participants will be randomly allocated to receive either BGB-16673 or the investigator's choice of treatment.