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Investigating a new treatment for chronic lymphocytic leukemia

A Multicenter, Open-Label, Phase 2 Study to Investigate the Efficacy and Safety of Sonrotoclax Combined With Zanubrutinib Compared With Zanubrutinib Monotherapy in Adult Patients With Previously Untreated Chronic Lymphocytic Leukemia

PHASE2 · BeiGene · NCT06637501

This study is testing a new combination treatment for adults with chronic lymphocytic leukemia to see if it works better than the current standard treatment alone.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment87 (estimated)
Ages18 Years and up
SexAll
SponsorBeiGene (industry)
Drugs / interventionszanubrutinib
Locations38 sites (Miami, Florida and 37 other locations)
Trial IDNCT06637501 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness and safety of sonrotoclax combined with zanubrutinib compared to zanubrutinib alone in adults with previously untreated chronic lymphocytic leukemia (CLL). Participants will be randomly assigned to receive either the combination treatment or zanubrutinib alone. The study will assess how many participants show improvement in cancer symptoms or achieve no evidence of cancer after treatment, as well as monitor any side effects experienced. The study will enroll approximately 87 participants and will take place at multiple centers worldwide over a period of about 5 years.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of previously untreated chronic lymphocytic leukemia requiring treatment.

Not a fit: Patients with known prolymphocytic leukemia, central nervous system involvement, or those who have received previous systemic treatment for CLL may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective option for patients with chronic lymphocytic leukemia.

How similar studies have performed: Other studies have shown success with similar approaches in treating B cell malignancies, indicating potential for this combination treatment.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Previously untreated adult patient ≥ 18 years with a confirmed diagnosis of CLL.
2. CLL requiring treatment as per pre-defined criteria.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2.
4. Measurable disease by CT/MRI.
5. Adequate marrow function.
6. Adequate liver function as indicated by aspartate aminotransferase (AST) alanine aminotransferase (ALT) and serum total bilirubin.
7. Adequate renal function.
8. Life expectancy \> 6 months.
9. Signed informed consent and able to comply with the study protocol in the investigator's judgment.
10. Women of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 90 days after the last dose of study drug.

Exclusion Criteria:

1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
2. Known central nervous system involvement
3. Received previous systemic treatment for CLL
4. Clinically significant cardiovascular disease
5. Severe or debilitating pulmonary disease
6. History of prior malignancy
7. Active fungal, bacterial, and/or viral infection requiring systemic therapy
8. Positive HIV serology (HIVAb) status or serologic status reflecting active hepatitis B or C infection
9. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring treatment
10. History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention
11. History of stroke or intracranial hemorrhage ≤ 6 months before the first dose of study treatment
12. Unable to swallow capsules or tablets or diseases significantly affecting GI function
13. Hypersensitivity to zanubrutinib, sonrotoclax, or any of its excipients
14. Use of investigational agents within the last 4 weeks before screening
15. Pregnant and lactating females

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Where this trial is running

Miami, Florida and 37 other locations

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 →

Conditions: Chronic Lymphocytic Leukemia, CLL

Last reviewed 2026-05-15 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.