Status:
RECRUITING
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
Lead Sponsor:
BeOne Medicines
Conditions:
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 par...
Detailed 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, ...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of CLL/SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.
- Previously received treatment for CLL/SLL with a covalent BTKi.
- Measurable disease by computer tomography/magnetic resonance imaging for patients with SLL.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate bone marrow function
- Adequate kidney and liver function
- Adequate blood clotting function
Exclusion
- Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
- 2\. Prior autologous stem cell transplant (unless ≥ 3 months after transplant) or chimeric antigen receptor-T cell (unless ≥ 6 months after cell infusion)
- History of severe allergic reactions or hypersensitivity to the active ingredient and excipients of study treatment (BGB-16673, bendamustine, or rituximab)
- Current or history of central nervous system involvement
- History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug
- History of confirmed progressive multifocal leukoencephalopathy.
- Active fungal, bacterial, and/or viral infection requiring parenteral systemic therapy
- Clinically significant cardiovascular disease
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
May 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2029
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06970743
Start Date
May 29 2025
End Date
November 30 2029
Last Update
January 7 2026
Active Locations (64)
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1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230000
2
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100000
3
Peking University Peoples Hospital
Beijing, Beijing Municipality, China, 100044
4
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730