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NCT Number: NCT05640102

Observational Study Evaluating the Efficacy and Safety of Zanubrutinib in Participants With Waldenström Macroglobulinemia

This is a hybrid (retrospective and prospective) non-interventional registry study to further describe the clinical profile of zanubrutinib in Waldenström macroglobulinemia (WM) participants with and without specific mutations and from racial and ethnic minority groups. Data collected from this registry study will be used to better understand the clinical benefit and safety of zanubrutinib for the treatment of participants in these populations.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pan American Oncology Trials, Llc, Rio Piedras, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical and definitive histologic diagnosis of WM
  • Measurable disease, as defined by a serum immunoglobulin M (IgM) level > 0.5 g/dL at the time of zanubrutinib initiation
  • Started treatment with zanubrutinib, has been treated with zanubrutinib, or is planned to be prescribed zanubrutinib for the treatment of WM
  • Bone marrow specimens with central MYD88 test results of:
  • Cohort 1: MYD88 L265P mutation; enrollment of TN participants will be stopped in each racial and ethnic participant group when the required numbers of participants in the group are met
  • Cohort 2: non-L265P MYD88 mutation(s) and MYD88WT

Exclusion criteria

  • Evidence of disease transformation before the first dose of zanubrutinib
  • Evidence of other non-Hodgkin Lymphoma (NHL) subtypes
  • Prior or concurrent active malignancy ≤ 2 years before the first dose of zanubrutinib, except for malignancies that, in the investigator's opinion, will not obscure the interpretation of safety or efficacy results
  • Concurrent participation in another therapeutic clinical study while receiving zanubrutinib, although the participant may be eligible depending on the status of the interventional study after discussion with the Medical Monitor or designee on an individual basis

Treatment and study plan

Zanubrutinib

Drug

Dosing and treatment duration are at the discretion of the prescribing physician and in accordance with local labeling

Other names: BGB-3111, Brukinsa

Primary outcomes

  1. Major Response Rate (MRR)

    Time frame: Up to approximately 4 years

    MRR is defined as the proportion of participants achieving either complete response (CR), very good partial response (VGPR), or partial response (PR) as determined by the investigator using an adaptation of the response criteria updated at the Sixth International Workshop on WM (IWWM)

Secondary outcomes

  1. VGPR+ Rate

    Time frame: Up to approximately 5 years

    VGPR+ rate is defined as the proportion of participants achieving either CR or VGPR

  2. Overall Response Rate (ORR)

    Time frame: Up to approximately 5 years

    ORR is defined as the proportion of participants achieving either CR, VGPR, PR, or minor response (MR)

  3. Duration of Response (DOR)

    Time frame: Up to approximately 5 years

    DOR is defined as the time from the first determination of response (CR, VGPR, or PR) until first documentation of or death, whichever comes first

  4. Number of Participants with Treatment-emergent Adverse Events

    Time frame: Up to approximately 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Study Director

CONTACT

[email protected]

1-877-828-5568

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study title

A Phase 4, Observational Study Evaluating the Efficacy and Safety of the Bruton Tyrosine Kinase (BTK) Inhibitor Zanubrutinib in Patients With Waldenström Macroglobulinemia

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Dec 7, 2022
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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