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Waldenström's MacroglobulinemiaPhase 4NCT07169331

A Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Adults With Treatment-Naive Waldenström Macroglobulinemia

A Phase 4 study testing Zanubrutinib in people with Waldenström's Macroglobulinemia, run by BeiGene at 6 sites in China.

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 measure the efficacy and safety with zanubrutinib in adults with Treatment-Naive (TN) Waldenström Macroglobulinemia (WM). The main objective of this Phase 4 study is to further characterize the efficacy of zanubrutinib in Chinese participants with TN WM in order to fulfill the… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Waldenström's Macroglobulinemia
What is being tested?
Zanubrutinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
6 sitesChina
Study dates
17 Oct 2025to 31 Oct 2028
Phase
Phase 4
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

  • Clinical and definitive histologic diagnosis of WM. Participant must be treatment-naive.
  • Participant must meet at least 1 criterion for treatment according to consensus panel criteria from the Seventh International Workshop on Waldenström's macroglobulinemia (IWWM).
  • Participant must have measurable disease, as defined by serum immunoglobulin M (IgM) level > 0.5 g/dL.
  • Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
  • Participants must have adequate organ function as indicated by the following laboratory values ≤ 7 days before the first dose of study treatment:
  • Participants must not have required blood transfusion or growth factor support ≤ 7 days before sample collection at screening for the following:
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  • Absolute neutrophil count (ANC) ≥ 0.75 x 10^9/L.
  • Platelets ≥ 50 x 10^9/L.
  • Creatinine clearance of ≥ 30 ml/min as estimated by the Cockcroft-Gault formula.
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN).
  • Serum total bilirubin ≤ 2 x ULN (total bilirubin must be < 3 x ULN for participants with Gilbert syndrome).
  • Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for at least 1 month after the last dose of zanubrutinib. They must also have a negative urine or serum pregnancy test result ≤ 7 days before the first dose of study treatment.

Who cannot join

  • Evidence of disease transformation at the time of study entry.
  • Central nervous system (CNS) involvement by WM. Patients with a history of CNS involvement must undergo magnetic resonance imaging (MRI) and cerebrospinal fluid cytology studies to document no evidence of CNS disease prior to study entry.
  • Evidence of disease transformation at the time of study entry.
  • Participants with any of the following cardiovascular risk factors:
  • Active cardiac ischemia (eg, cardiac chest pain) ≤ 28 days before first dose of study drug.
  • Any history of acute myocardial infarction ≤ 6 months before the first dose of study drug.
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  • Any history of heart failure meeting New York Heart Association (NYHA) Classification III or IV (Appendix 7)≤ 6 months before the first dose of study drug.
  • Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before the first dose of study drug.
  • Active, clinically significant second-degree atrioventricular block Mobitz II, or third degree atrioventricular block.
  • Any history of cerebrovascular accident ≤ 6 months before the first dose of study drug.
  • Uncontrolled hypertension that cannot be managed by standard antihypertension medications ≤ 28 days before the first dose of study drug.
  • Any episode of syncope or seizure ≤ 28 days before first dose of study drug.
  • At the time of study entry, participants taking warfarin or other vitamin K antagonists.
  • Participants requiring ongoing therapy with strong or moderate cytochrome CYP3A inducers
  • Corticosteroids given with antineoplastic intent within 7 days, or chemotherapy, targeted therapy, or radiation therapy within 4 weeks, or antibody-based therapy within 4 weeks before the start of study drug.
  • Major surgical procedure within 4 weeks before the start of study treatment (bone marrow aspirate and biopsy procedures are not considered major surgical procedures).
  • Note: Other protocol defined criteria may apply

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • Affiliated Hospital of Hebei University

    Baoding, Hebei, 071000

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410008

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • Yichang Central Peoples Hospital

    Yichang, Hubei, 443003

Other trials in China

About this study

Official title: A Phase 4, Single-Arm, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Patients With Treatment-Naive Waldenström Macroglobulinemia

The purpose of this study is to measure the efficacy and safety with zanubrutinib in adults with Treatment-Naive (TN) Waldenström Macroglobulinemia (WM). The main objective of this Phase 4 study is to further characterize the efficacy of zanubrutinib in Chinese participants with TN WM in order to fulfill the post-marketing requirements from the National Medical Products Administration (NMPA). Safety data will be collected and evaluated in this study as well.

Being tested
Zanubrutinib
Medical subject headings
Waldenstrom Macroglobulinemia

What participants receive

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

  • ZanubrutinibDrug

    Also called Brukinsa, BGB-3111

    Administered orally

Study groups in NCT07169331
Study groupRoleWhat they receive
ZanubrutinibExperimentalParticipants will receive 160 mg zanubrutinib orally twice a day until progressive disease, unacceptable toxicity or death, withdrawal of consent, loss to follow-up, or study termination by the sponsor for any reason.
Receives: Drug: Zanubrutinib

What is being measured

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

  1. Percentage of Participants Achieving a Complete Response (CR) or Very Good Partial Response (VGPR) as Assessed by the Investigator

    The percentage of participants who achieve either a complete response or very good partial response (VGPR) as determined by the investigator using an adaptation of the response criteria updated at the Sixth International Workshop on Waldenström's macroglobulinemia (IWWM).

    Measured: Up to approximately 33 Months

Secondary outcomes (4)

  1. Major Response Rate (MRR) as Assessed by the Investigator

    MRR is defined as the percentage of participants achieving CR, VGPR, or partial response (PR) as determined by the investigator per the modified IWWM criteria.

    Measured: Up to approximately 33 Months

  2. Duration of Major Response (DOMR) as Assessed by the Investigator

    DOMR is defined as the time from first determination of response (CR, VGPR, or PR) (per modified IWWM criteria) until first documentation of disease progression (per modified IWWM criteria) or death, whichever comes first

    Measured: Up to approximately 33 Months

  3. Progression-free Survival (PFS) as Assessed by the Investigator

    Progression-free survival (PFS) as assessed by the investigator, defined as time from start of treatment to the first documentation of disease progression (per modified IWWM criteria) or death, whichever occurs first.

    Measured: Up to approximately 33 Months

  4. Number of Participant with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory values, vital signs, physical examination findings, and electrocardiogram results.

    Measured: From first dose of study drug until 30 days after the last dose, up to approximately 33 months

Timeline

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

  1. First posted11 Sep 2025
  2. Study start17 Oct 2025
  3. Primary completion31 Oct 2028 (estimated)
  4. Study completion31 Oct 2028 (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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07169331
Sponsor's protocol ID
BGB-3111-404
Status last verified
Aug 2026
First submitted
5 Sep 2025
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: BeiGene 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. BeiGene 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 BeiGene 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 4 study testing Zanubrutinib in people with Waldenström's Macroglobulinemia, run by BeiGene at 6 sites in China.

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 12 inclusion and 17 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 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Percentage of Participants Achieving a Complete Response (CR) or Very Good Partial Response (VGPR) as Assessed by the Investigator (time frame: Up to approximately 33 Months). 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 NCT07169331.

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 10 Aug 2026.

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