NCT06970743 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
| NCT ID | NCT06970743 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | BeOne Medicines |
| Condition | Chronic Lymphocytic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-05-29 |
| Primary Completion | 2029-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 150 participants in total. It began in 2025-05-29 with a primary completion date of 2029-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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.
Contact & Investigator
Study Director Study Director
STUDY DIRECTOR
BeOne Medicines
Frequently Asked Questions
Who can join the NCT06970743 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Lymphocytic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06970743 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 150 participants.
Is NCT06970743 currently recruiting?
Yes, NCT06970743 is actively recruiting participants. Contact the research team at clinicaltrials@beonemed.com for enrollment information.
Where is the NCT06970743 trial being conducted?
This trial is being conducted at Hefei, China, Beijing, China, Beijing, China, Beijing, China and 11 additional locations.
Who is sponsoring the NCT06970743 clinical trial?
NCT06970743 is sponsored by BeOne Medicines. The principal investigator is Study Director Study Director at BeOne Medicines. The trial plans to enroll 150 participants.
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