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Trial Title:
Observational Study Evaluating the Efficacy and Safety of Zanubrutinib in Participants With Waldenström Macroglobulinemia
NCT ID:
NCT05640102
Condition:
Waldenstrom Macroglobulinemia
Conditions: Official terms:
Waldenstrom Macroglobulinemia
Zanubrutinib
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Drug
Intervention name:
Zanubrutinib
Description:
Dosing and treatment duration are at the discretion of the prescribing physician and in
accordance with local labeling
Arm group label:
Cohort 1: MYD88 L265P mutation
Arm group label:
Cohort 2: Non-L265P MYD88 mutation(s) and MYD88 wildtype
Other name:
BGB-3111
Other name:
Brukinsa
Summary:
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.
Criteria for eligibility:
Study pop:
Adult participants with WM who are either already receiving or are planned to start
treatment with zanubrutinib
Sampling method:
Non-Probability Sample
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:
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 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope National Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Facility:
Name:
Eisenhower Medical Center, Lucy Curci Cancer Center
Address:
City:
Rancho Mirage
Zip:
92270
Country:
United States
Status:
Recruiting
Facility:
Name:
Pacific Central Coast Health Centers, Slo Oncology and Hematology Health Center
Address:
City:
San Luis Obispo
Zip:
93401
Country:
United States
Status:
Recruiting
Facility:
Name:
Hattiesburg Hematology and Oncology Clinic
Address:
City:
Hattiesburg
Zip:
39401
Country:
United States
Status:
Recruiting
Facility:
Name:
Comprehensive Cancer Centers of Nevada
Address:
City:
Las Vegas
Zip:
89169
Country:
United States
Status:
Recruiting
Facility:
Name:
Pan American Oncology Trials, Llc
Address:
City:
Rio Piedras
Zip:
00935
Country:
Puerto Rico
Status:
Recruiting
Start date:
March 3, 2023
Completion date:
December 2027
Lead sponsor:
Agency:
BeiGene
Agency class:
Industry
Source:
BeiGene
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05640102
