NCT06846671 A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors
| NCT ID | NCT06846671 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | BeOne Medicines |
| Condition | CLL |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2025-04-10 |
| Primary Completion | 2028-05-15 |
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 250 participants in total. It began in 2025-04-10 with a primary completion date of 2028-05-15.
⚠ 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 (idelalisib plus rituximab \[for CLL only\] or bendamustine plus rituximab or venetoclax plus rituximab retreatment) in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).
Eligibility Criteria
Inclusion Criteria: 1. Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria. 2. Previously received treatment for CLL/SLL with both a BTKi and a BCL2i. 3. Participants with SLL must have measurable disease by computer tomography (CT)/magnetic resonance imaging (MRI) 4. Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2 5. Adequate liver function 6. Adequate blood clotting function Exclusion Criteria: 1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation 2. Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 months 3. Known central nervous system involvement 4. Prior exposure to any BTK protein degraders 5. Active fungal, bacterial and/or viral infection requiring parenteral systemic therapy 6. Clinically significant cardiovascular disease NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Contact & Investigator
Study Director
STUDY DIRECTOR
BeOne Medicines
Frequently Asked Questions
Who can join the NCT06846671 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying CLL. 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 NCT06846671 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 250 participants.
Is NCT06846671 currently recruiting?
Yes, NCT06846671 is actively recruiting participants. Contact the research team at clinicaltrials@beonemed.com for enrollment information.
Where is the NCT06846671 trial being conducted?
This trial is being conducted at Jonesboro, United States, Los Angeles, United States, Whittier, United States, Aurora, United States and 11 additional locations.
Who is sponsoring the NCT06846671 clinical trial?
NCT06846671 is sponsored by BeOne Medicines. The principal investigator is Study Director at BeOne Medicines. The trial plans to enroll 250 participants.