NCT07277231 A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia
| NCT ID | NCT07277231 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | BeOne Medicines |
| Condition | Chronic Lymphocytic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2026-01-22 |
| Primary Completion | 2031-02 |
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 500 participants in total. It began in 2026-01-22 with a primary completion date of 2031-02.
⚠ 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 fixed-duration sonrotoclax (also known as BGB-11417) plus zanubrutinib (also known as BGB-3111) (SZ) compared with fixed-duration of venetoclax plus acalabrutinib (AV) in participants with previously untreated chronic lymphocytic leukemia (CLL).
Eligibility Criteria
Inclusion Criteria: * Treatment-naïve (TN) adults with confirmed diagnosis of CLL which requires treatment * Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2 * Measurable disease by Computer Tomography/Magnetic Resonance Imaging * Adequate bone marrow and organ function Exclusion Criteria: * Previous systemic treatment for CLL * Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation * Known central nervous system involvement * History of confirmed progressive multifocal leukoencephalopathy (PML) * Uncontrolled hypertension or 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 NCT07277231 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 NCT07277231 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 500 participants.
Is NCT07277231 currently recruiting?
Yes, NCT07277231 is actively recruiting participants. Contact the research team at clinicaltrials@beonemed.com for enrollment information.
Where is the NCT07277231 trial being conducted?
This trial is being conducted at Duarte, United States, Orange, United States, Palo Alto, United States, Aurora, United States and 11 additional locations.
Who is sponsoring the NCT07277231 clinical trial?
NCT07277231 is sponsored by BeOne Medicines. The principal investigator is Study Director at BeOne Medicines. The trial plans to enroll 500 participants.
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