A Phase 2 interventional study of Sonrotoclax and Zanubrutinib in Chronic Lymphocytic Leukemia, sponsored by BeOne Medicines. Active, not recruiting at 32 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by BeOne Medicines · Phase 2, Interventional, and Treatment
The purpose of this study is to support the registration plan of sonrotoclax plus zanubrutinib treatment in participants with previously untreated chronic lymphocytic leukemia (CLL). This study is designed to assess the contribution of sonrotoclax to the efficacy outcome of the combination of zanubrutinib and sonrotoclax.
This study will test how effective and safe Sonrotoclax plus Zanubrutinib treatment compared with Zanubrutinib alone in participants with previously untreated chronic lymphocytic leukemia (CLL).
The main goals of the study are to determine how many participants may no longer have evidence of cancer or have some improvement in the signs and symptoms of cancer after treatment and to determine what adverse events, or side effects, patients might experience.
Sonrotoclax is an experimental drug that works by blocking a protein called B-cell lymphoma-2 (Bcl-2). This protein helps certain types of blood tumor cells to survive and grow. When Sonrotoclax blocks Bcl-2 it slows down or stops the growth of tumor cells and helps them die. This can lead to improvements in patients with CLL disease.
Zanubrutinib is a commercialized product that works by blocking a protein called Bruton's tyrosine kinase (BTK) and controlling the activity and survival of malignant B cells. Zanubrutinib has received approval in over 65 countries/regions worldwide for the treatment of adult participants with B cell malignancies, including CLL.
The study will enroll approximately 87 participants who will be randomly assigned by a computer program to receive one of the following treatments: sonrotoclax + zanubrutinib or zanubrutinib.
The study will take place at multiple centers worldwide. The overall time to participate in this study is approximately 5 years.
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
1,603 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 243 are open to participants now.
This study's planned enrollment of 94 is above the median of 40 across 1,325 interventional studies indexed under Leukemia, Lymphocytic, Chronic, B-Cell.
Browse Leukemia, Lymphocytic, Chronic, B-Cell studies →BeOne Medicines is the lead sponsor of 61 studies on the registry; 42 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Participants will receive sonrotoclax in combination with zanubrutinib daily for a fixed duration of 15 cycles.
Drug: Sonrotoclax · Drug: Zanubrutinib
Participants will receive zanubrutinib monotherapy daily until disease progression or unacceptable toxicity, whichever occurs first.
Drug: Zanubrutinib
Administered orally
Also known as: BGB-11417
Administered orally
Also known as: BRUKINSA, BGB-3111
Complete Response (CR)/ Complete Response with Incomplete Bone Marrow Recovery (CRi) Rate
Best CR/CRi rate per the Independent Review Committee (IRC) response assessment using the 2018 International Workshop on Chronic Lymphocytic Leukemia guidelines with modification for treatment-related lymphocytosis for participants with CLL
Time frame: Month 16
Undetectable Minimal Residual Disease at < 10^-4Sensitivity (uMRD4) Rate
uMRD4 rate measured in both peripheral blood and bone marrow aspirate
Time frame: Month 16
CR/CRi Rate per Investigator Response Assessment
CR/CRi Rate (CRR) is defined as the percentage of participants with best overall response of CR or CRi
Time frame: Month 16
Overall Response Rate (ORR) per IRC and Investigator Response Assessment
ORR is defined as the percentage of participants achieving overall response (CR+CRi+partial response \[PR\]+nodular PR) per the IRC and the investigator response assessment.
Time frame: Up to 66 Months
Duration of Response (DOR) per Investigator Response Assessment
DOR is defined as the time from first qualifying response (PR, nodular PR, CR,or CRi) until CLL progression or death.
Time frame: Up to 66 Months
Time to Response (TTR) per IRC and Investigator Response Assessment
TTR is defined as the time from treatment initiation to the first documentation of response
Time frame: Up to 66 Months
Landmark Progression-free Survival Rate at 24 Months per Investigator Assessment
The 24-month landmark PFS rate is defined as the percentage of participants who remain alive and progression-free at 24 months since the start of treatment
Time frame: 24 Months
Progression-free Survival (PFS) per Investigator Response Assessment
PFS is defined as the time from the start of treatment to the first documentation of disease progression or death, whichever occurs first
Time frame: Up to 66 Months
Overall Survival (OS)
OS is defined as the time from treatment initiation to death due to any cause
Time frame: Up to 66 Months
Number of Participants with Adverse Events (AEs)
Safety will be assessed by monitoring and recording of all treatment emergent adverse events (AEs) graded by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
Time frame: From first dose of study drug to 30 days after last dose; up to 66 months for Arm A and Arm B
Plan to share: Yes — BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Supporting information: Study protocol, Sap, Csr
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Leukemia, Lymphocytic, Chronic, B-Cell→
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