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Comparing two treatment combinations for chronic lymphocytic leukemia

A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Patients With Previously Untreated Chronic Lymphocytic Leukemia

Phase 3 Interventional BeiGene · NCT06073821

This study is testing if a new combination of two drugs can help people with chronic lymphocytic leukemia live longer without their cancer getting worse compared to the standard treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment652 (estimated)
Ages18 Years and up
SexAll
SponsorBeiGene Industry-sponsored
Drugs / interventionsobinutuzumab, zanubrutinib
Locations210 sites (Anchorage, Alaska and 209 other locations)
Trial IDNCT06073821 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of sonrotoclax combined with zanubrutinib against the standard treatment of venetoclax plus obinutuzumab in patients with chronic lymphocytic leukemia (CLL) who have not received prior treatment. Participants will be randomly assigned to one of the two treatment groups, and the primary outcome will be the duration of time participants live without their CLL worsening. The study will enroll approximately 652 participants globally, focusing on improving treatment outcomes for this blood cancer.

Who should consider this trial

Good fit: Ideal candidates for this study are treatment-naïve adults with a confirmed diagnosis of chronic lymphocytic leukemia requiring treatment.

Not a fit: Patients who have previously received systemic treatment for CLL or have certain complications, such as central nervous system involvement, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with chronic lymphocytic leukemia, potentially leading to longer survival and better quality of life.

How similar studies have performed: Other studies have shown promise in using novel combinations for treating CLL, but this specific combination is being evaluated for the first time in this context.

Eligibility criteria

Show full inclusion / exclusion 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 liver function as indicated by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x the institutional upper limits of normal (ULNs) value; serum total bilirubin \< 3.0 x ULN
* Adequate renal function as defined as creatinine clearance ≥ 50 milliliters per minute

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

Note: Other protocol defined criteria may apply

Where this trial is running

Anchorage, Alaska and 209 other locations

+160 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions CLLChronic Lymphocytic Leukemia
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.