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

NCT07169331 | Recruiting Phase 4

• 1 other identifier: BGB-3111-404
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 8

Brief 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 post-marketing requirements from the National Medical Products Administration (NMPA). Safety data will be collected and evaluated in this study as well.

Conditions

Waldenström's Macroglobulinemia

Outcome Measures

Primary Outcomes (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).

  Up to approximately 33 Months

Secondary Outcomes (4)

• Major Response Rate (MRR) as Assessed by the Investigator

  Up to approximately 33 Months

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

  Up to approximately 33 Months

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

  Up to approximately 33 Months

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

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

Study Arms (1)

Zanubrutinib

EXPERIMENTAL

Participants 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.

Drug: Zanubrutinib

Interventions

Zanubrutinib DRUG

Administered orally

Also known as: Brukinsa, BGB-3111

Zanubrutinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• BeiGene: lead

Study Sites (8)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Sun Yat Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Affiliated Hospital of Hebei University

Baoding, Hebei, 071000, China

RECRUITING

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

Yichang Central Peoples Hospital

Yichang, Hubei, 443003, China

RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Waldenstrom Macroglobulinemia

Interventions

zanubrutinib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Study Director

  BeiGene

  STUDY DIRECTOR

Central Study Contacts

Study Director

CONTACT

1-877-828-5568; clinicaltrials@beigene.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 11, 2025
• Study Start: October 17, 2025
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: December 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

CN (8)