Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT06200220
Status:
RECRUITING
Last Update Posted:
2024-01-10
First Post:
2023-12-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Patients Treated in Real Life With VEnetoclax for WAldenström Macroglobulinemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C579720', 'term': 'venetoclax'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-28', 'studyFirstSubmitDate': '2023-12-28', 'studyFirstSubmitQcDate': '2023-12-28', 'lastUpdatePostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficiency', 'timeFrame': '2018 to 2025', 'description': 'ORR, MRR'}], 'secondaryOutcomes': [{'measure': 'Tolerance', 'timeFrame': '2018 to 2025', 'description': 'Adverse events'}, {'measure': 'Efficiency in specific population', 'timeFrame': '2018 to 2025', 'description': 'ORR in CXCR4 mutated patients, ORR in patients previously treated with BTK inhibitors'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Waldenstrom's Macroglobulinaemia Refractory"]}, 'descriptionModule': {'briefSummary': 'Waldenström macroglobulinemia (WM) is an incurable disease. BCL2 antagonist, an important anti-apoptosys molecule, is already approved for the treatment of chronic lymphocytic leukemia (CLL) and acute myeloid leukemia. Recently, a clinical trial including 32 patients with WM treated with Venetoclax showed an overall response rates of 84% and a major response rate of 81%. However, there is no in real life data, in the french population, of the efficiency of Venetoclax in WM. The aim of our multicentric retrospective study is to evaluate the efficiency and tolerance of Venetoclax in WM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from university hospitals in France (16 center)', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Waldenstrom's macroglobulinemia\n* Treatment with Venetoclax\n* Non opposition\n\nExclusion Criteria: none"}, 'identificationModule': {'nctId': 'NCT06200220', 'briefTitle': 'Patients Treated in Real Life With VEnetoclax for WAldenström Macroglobulinemia', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'officialTitle': 'Patients Treated in Real Life With VEnetoclax for WAldenström Macroglobulinemia', 'orgStudyIdInfo': {'id': 'WAVE'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Venetoclax', 'type': 'DRUG', 'description': 'Observational study'}]}, 'contactsLocationsModule': {'locations': [{'zip': '86000', 'city': 'Poitiers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Xavier LELEU, Pr', 'role': 'CONTACT', 'email': 'xavier.leleu@chu-poitiers.fr', 'phone': '+33(0)549444444'}], 'facility': 'CHU Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}], 'centralContacts': [{'name': 'cécile tomowiak, Dr', 'role': 'CONTACT', 'email': 'cecile.tomowiak@chu-poitiers.fr', 'phone': '+33 (0)5.49.44.43.07'}, {'name': 'Mathilde Vonfeld, Intern', 'role': 'CONTACT', 'email': 'mathilde.vonfeld@chu-poitiers.fr', 'phone': '+33 (0)5.49.44.43.07'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}