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Recruiting NCT05640102

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

— Observational Waldenstrom Macroglobulinemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Zanubrutinib.
Who it may be relevant to
Registry conditions: Waldenstrom Macroglobulinemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Puerto Rico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Major Response Rate (MRR) [Time frame: Up to approximately 4 years]
Secondary outcome measures (4)
  • VGPR+ Rate [Time frame: Up to approximately 5 years]
  • Overall Response Rate (ORR) [Time frame: Up to approximately 5 years]
  • Duration of Response (DOR) [Time frame: Up to approximately 5 years]
  • Number of Participants with Treatment-emergent Adverse Events [Time frame: Up to approximately 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 7 centers
  • Clearview Cancer Institute — Huntsville
  • South Alabama Medical Science Foundation Mitchell Cancer Institute — Mobile
  • City of Hope National Medical Center — Duarte
  • Los Angeles Cancer Network (Lacn) — Glendale
  • Eisenhower Medical Center, Lucy Curci Cancer Center — Rancho Mirage
  • Hattiesburg Hematology and Oncology Clinic — Hattiesburg
  • Comprehensive Cancer Centers of Nevada — Las Vegas
Puerto Rico · 1 center
  • Pan American Oncology Trials, Llc — Rio Piedras

Identifiers

NCT: NCT05640102 · BGB-3111-402

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗