Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT05640102
Status:
RECRUITING
Last Update Posted:
2025-11-12
First Post:
2022-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational Study Evaluating the Efficacy and Safety of Zanubrutinib in Participants With Waldenström Macroglobulinemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008258', 'term': 'Waldenstrom Macroglobulinemia'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629551', 'term': 'zanubrutinib'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 111}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-11', 'studyFirstSubmitDate': '2022-11-28', 'studyFirstSubmitQcDate': '2022-11-28', 'lastUpdatePostDateStruct': {'date': '2025-11-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Response Rate (MRR)', 'timeFrame': 'Up to approximately 4 years', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'VGPR+ Rate', 'timeFrame': 'Up to approximately 5 years', 'description': 'VGPR+ rate is defined as the proportion of participants achieving either CR or VGPR'}, {'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'Up to approximately 5 years', 'description': 'ORR is defined as the proportion of participants achieving either CR, VGPR, PR, or minor response (MR)'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to approximately 5 years', 'description': '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'}, {'measure': 'Number of Participants with Treatment-emergent Adverse Events', 'timeFrame': 'Up to approximately 5 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Waldenstrom Macroglobulinemia']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult participants with WM who are either already receiving or are planned to start treatment with zanubrutinib', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical and definitive histologic diagnosis of WM\n* Measurable disease, as defined by a serum immunoglobulin M (IgM) level \\> 0.5 g/dL at the time of zanubrutinib initiation\n* Started treatment with zanubrutinib, has been treated with zanubrutinib, or is planned to be prescribed zanubrutinib for the treatment of WM\n* Bone marrow specimens with central MYD88 test results of:\n\n 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\n 2. Cohort 2: non-L265P MYD88 mutation(s) and MYD88WT\n\nExclusion Criteria:\n\n* Evidence of disease transformation before the first dose of zanubrutinib\n* Evidence of other non-Hodgkin Lymphoma (NHL) subtypes\n* 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\n* 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"}, 'identificationModule': {'nctId': 'NCT05640102', 'briefTitle': 'Observational Study Evaluating the Efficacy and Safety of Zanubrutinib in Participants With Waldenström Macroglobulinemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'BeOne Medicines'}, 'officialTitle': 'A Phase 4, Observational Study Evaluating the Efficacy and Safety of the Bruton Tyrosine Kinase (BTK) Inhibitor Zanubrutinib in Patients With Waldenström Macroglobulinemia', 'orgStudyIdInfo': {'id': 'BGB-3111-402'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1: MYD88 L265P mutation', 'description': 'Arm A: Treatment-naïve (TN); Arm B: Relapsed/refractory (R/R)', 'interventionNames': ['Drug: Zanubrutinib']}, {'label': 'Cohort 2: Non-L265P MYD88 mutation(s) and MYD88 wildtype', 'description': 'Arm C: TN and R/R', 'interventionNames': ['Drug: Zanubrutinib']}], 'interventions': [{'name': 'Zanubrutinib', 'type': 'DRUG', 'otherNames': ['BGB-3111', 'Brukinsa'], 'description': 'Dosing and treatment duration are at the discretion of the prescribing physician and in accordance with local labeling', 'armGroupLabels': ['Cohort 1: MYD88 L265P mutation', 'Cohort 2: Non-L265P MYD88 mutation(s) and MYD88 wildtype']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35805-2606', 'city': 'Huntsville', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clearview Cancer Institute', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '36604-1405', 'city': 'Mobile', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'South Alabama Medical Science Foundation Mitchell Cancer Institute', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '91010-3012', 'city': 'Duarte', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'City of Hope National Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '91204-3640', 'city': 'Glendale', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Los Angeles Cancer Network (Lacn)', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '92270-3221', 'city': 'Rancho Mirage', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Eisenhower Medical Center, Lucy Curci Cancer Center', 'geoPoint': {'lat': 33.73974, 'lon': -116.41279}}, {'zip': '39401-7233', 'city': 'Hattiesburg', 'state': 'Mississippi', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Hattiesburg Hematology and Oncology Clinic', 'geoPoint': {'lat': 31.32712, 'lon': -89.29034}}, {'zip': '89169-3321', 'city': 'Las Vegas', 'state': 'Nevada', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Comprehensive Cancer Centers of Nevada', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '00935', 'city': 'Rio Piedras', 'status': 'RECRUITING', 'country': 'Puerto Rico', 'facility': 'Pan American Oncology Trials, Llc', 'geoPoint': {'lat': 18.39745, 'lon': -66.04989}}], 'centralContacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'clinicaltrials@beigene.com', 'phone': '1-877-828-5568'}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'BeiGene'}]}, 'ipdSharingStatementModule': {'url': 'https://beigene.com/science/clinical-trials/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'See plan description', 'ipdSharing': 'YES', 'description': 'BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.\n\nBeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.\n\nQualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.', 'accessCriteria': 'See plan description'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BeiGene', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}