Observational Study Evaluating the Efficacy and Safety of Zanubrutinib in Participants With Waldenström Macroglobulinemia
NCT ID: NCT05640102
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
111 participants
OBSERVATIONAL
2023-03-03
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Cohort 1: MYD88 L265P mutation
Arm A: Treatment-naïve (TN); Arm B: Relapsed/refractory (R/R)
Zanubrutinib
Dosing and treatment duration are at the discretion of the prescribing physician and in accordance with local labeling
Cohort 2: Non-L265P MYD88 mutation(s) and MYD88 wildtype
Arm C: TN and R/R
Zanubrutinib
Dosing and treatment duration are at the discretion of the prescribing physician and in accordance with local labeling
Interventions
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Zanubrutinib
Dosing and treatment duration are at the discretion of the prescribing physician and in accordance with local labeling
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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Clearview Cancer Institute
Huntsville, Alabama, United States
South Alabama Medical Science Foundation Mitchell Cancer Institute
Mobile, Alabama, United States
City of Hope National Medical Center
Duarte, California, United States
Los Angeles Cancer Network (Lacn)
Glendale, California, United States
Eisenhower Medical Center, Lucy Curci Cancer Center
Rancho Mirage, California, United States
Hattiesburg Hematology and Oncology Clinic
Hattiesburg, Mississippi, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Pan American Oncology Trials, Llc
Rio Piedras, , Puerto Rico
Countries
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Central Contacts
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Other Identifiers
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BGB-3111-402
Identifier Type: -
Identifier Source: org_study_id