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

Description

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.

Conditions

Waldenstrom Macroglobulinemia

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Study Overview

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Study Details

Study 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.

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

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

Condition
Waldenstrom Macroglobulinemia
Intervention / Treatment

-

Contacts and Locations

Huntsville

Clearview Cancer Institute, Huntsville, Alabama, United States, 35805

Mobile

Mitchell Cancer Institute, Mobile, Alabama, United States, 36604

Duarte

City of Hope National Medical Center, Duarte, California, United States, 91010

Los Angeles

Valkyrie Clinical Trials, Los Angeles, California, United States, 90067

Rancho Mirage

Eisenhower Medical Center, Lucy Curci Cancer Center, Rancho Mirage, California, United States, 92270

San Luis Obispo

Pacific Central Coast Health Centers, Slo Oncology and Hematology Health Center, San Luis Obispo, California, United States, 93401

Santa Maria

Pacific Central Coast Health Centers, Mission Hope Medical Oncology, Santa Maria, California, United States, 93454

Plantation

Brcr Medical Center, Inc, Plantation, Florida, United States, 33322

New Orleans

Tulane Cancer Center, New Orleans, Louisiana, United States, 70112

Hattiesburg

Hattiesburg Hematology and Oncology Clinic, Hattiesburg, Mississippi, United States, 39401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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:
  • 1. 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
  • 2. Cohort 2: non-L265P MYD88 mutation(s) and MYD88WT
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

BeiGene,

Study Director, STUDY_DIRECTOR, BeiGene

Study Record Dates

2027-12