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Chronic Lymphocytic LeukemiaPhase 2NCT06637501

A Study to Investigate Sonrotoclax Combined With Zanubrutinib Versus Zanubrutinib Alone in Participants With Previously Untreated Chronic Lymphocytic Leukemia

A Phase 2 study testing Sonrotoclax and Zanubrutinib in people with Chronic Lymphocytic Leukemia, run by BeOne Medicines at 32 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
Sonrotoclax and Zanubrutinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
32 sitesin 6 countries
Study dates
14 Nov 2024to Sep 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Previously untreated adult patient ≥ 18 years with a confirmed diagnosis of CLL.
  • CLL requiring treatment as per pre-defined criteria.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0,1, or 2.
  • Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI).
  • Adequate marrow function.
  • Adequate liver function as indicated by aspartate aminotransferase (AST) alanine aminotransferase (ALT) and serum total bilirubin.
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  • Adequate renal function.
  • Life expectancy > 6 months.
  • Signed informed consent and able to comply with the study protocol in the investigator's judgment.
  • 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.

Who cannot join

  • Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
  • Known central nervous system involvement
  • Received previous systemic treatment for CLL
  • Clinically significant cardiovascular disease
  • Severe or debilitating pulmonary disease
  • History of prior malignancy
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  • Active fungal, bacterial, and/or viral infection requiring systemic therapy
  • Positive human immunodeficiency virus (HIV) serology (HIVAb) status or serologic status reflecting active hepatitis B or C infection
  • Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring treatment
  • 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
  • History of stroke or intracranial hemorrhage ≤ 6 months before the first dose of study treatment
  • Unable to swallow capsules or tablets or diseases significantly affecting GI function
  • Hypersensitivity to zanubrutinib, sonrotoclax, or any of its excipients
  • Use of investigational agents within the last 4 weeks before screening
  • Pregnant and lactating females
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply

Trial locations and contacts

32 sites in 6 countries.

32 sites in 6 countries

United States11 sites

  • The University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

  • Texas Oncology Dfw

    Dallas, Texas, 75231-7001

  • Oncology Associates of Oregon Willamette Valley Cancer Center

    Eugene, Oregon, 97401

  • Northwest Georgia Oncology Centers Marietta

    Marietta, Georgia, 30060-1152

  • Illinois Cancer Specialists (Niles) Usor

    Niles, Illinois, 60714-5905

  • Nebraska Cancer Specialists (Satellite Site)

    Omaha, Nebraska, 68130-2042

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130-2042

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Utah Cancer Specialists Cancer Center

    Salt Lake City, Utah, 84107

  • Texas Oncology Tyler

    Tyler, Texas, 75702-7522

  • Cleveland Clinic Florida

    Weston, Florida, 33331-3609

Other trials in United States

China6 sites

  • The First Peoples Hospital of Changzhou

    Changzhou, Jiangsu, 213000

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

Other trials in China

Brazil4 sites

  • Centro de Pesquisas Oncologicas Cepon

    Florianópolis, 88034-000

  • Hospital de Clinicas de Porto Alegre

    Porto AlegreRS, 900350-903

  • Instituto Dor de Pesquisa E Ensino Sao Paulo

    São Paulo, 01401-004

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo, 05652-900

Other trials in Brazil

Italy4 sites

  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

    Brescia, 25123

  • Aou Careggi, Servizio Sanitario Toscana

    Florence, 50134

  • Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco

    Modena, 41124

  • Aoor Villa Sofia Cervello

    Palermo, 90146

Other trials in Italy

Poland4 sites

  • Pratia Onkologia Katowice

    Katowice, 40-519

  • Pratia McM Krakow

    Krakow, 30-727

  • Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie

    Lublin, 20-090

  • Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu

    Wroclaw, 50-367

Other trials in Poland

Spain3 sites

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital de Cabuenes

    Gijón, 33394

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

Other trials in Spain

About this study

Official title: 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

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.

Read the detailed description

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.

Being tested
Sonrotoclax, Zanubrutinib
Keywords
CLL
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SonrotoclaxDrug

    Also called BGB-11417

    Administered orally

  • ZanubrutinibDrug

    Also called BRUKINSA, BGB-3111

    Administered orally

Study groups in NCT06637501
Study groupRoleWhat they receive
Arm A: Combination Therapy: Sonrotoclax + ZanubrutinibExperimentalParticipants will receive sonrotoclax in combination with zanubrutinib daily for a fixed duration of 15 cycles.
Receives: Drug: Sonrotoclax; Drug: Zanubrutinib
Arm B: Monotherapy: ZanubrutinibActive comparatorParticipants will receive zanubrutinib monotherapy daily until disease progression or unacceptable toxicity, whichever occurs first.
Receives: Drug: Zanubrutinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Month 16

Secondary outcomes (9)

  1. Undetectable Minimal Residual Disease at < 10^-4Sensitivity (uMRD4) Rate

    uMRD4 rate measured in both peripheral blood and bone marrow aspirate

    Measured: Month 16

  2. 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

    Measured: Month 16

  3. 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.

    Measured: Up to 66 Months

  4. 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.

    Measured: Up to 66 Months

  5. 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

    Measured: Up to 66 Months

  6. 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

    Measured: 24 Months

  7. 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

    Measured: Up to 66 Months

  8. Overall Survival (OS)

    OS is defined as the time from treatment initiation to death due to any cause

    Measured: Up to 66 Months

  9. 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

    Measured: From first dose of study drug to 30 days after last dose; up to 66 months for Arm A and Arm B

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2024
  2. Study start14 Nov 2024
  3. Primary completionNov 2026 (estimated)
  4. Study completionSep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
94 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06637501
Sponsor's protocol ID
BGB-11417-204
Other IDs
2024-513970-23-00
Status last verified
Jul 2026
First submitted
9 Oct 2024
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sonrotoclax and Zanubrutinib in people with Chronic Lymphocytic Leukemia, run by BeOne Medicines at 32 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, China, Brazil, Italy, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Response (CR)/ Complete Response with Incomplete Bone Marrow Recovery (CRi) Rate (time frame: Month 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06637501.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.

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