Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT05218902
Status:
COMPLETED
Last Update Posted:
2023-05-31
First Post:
2022-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Azacitidine in Participants With International Prognostic Scoring System (IPSS) Intermediate-2 and High-risk Myelodysplastic Syndromes (MDS), or Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D015477', 'term': 'Leukemia, Myelomonocytic, Chronic'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D054437', 'term': 'Myelodysplastic-Myeloproliferative Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 290}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-26', 'studyFirstSubmitDate': '2022-01-20', 'studyFirstSubmitQcDate': '2022-01-20', 'lastUpdatePostDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse Events (AEs)', 'timeFrame': 'Up to 12 Months'}, {'measure': 'Incidence of Serious Adverse Events (SAEs)', 'timeFrame': 'Up to 12 Months'}, {'measure': 'Incidence of Adverse Drug Reactions (ADRs)', 'timeFrame': 'Up to 12 Months'}], 'secondaryOutcomes': [{'measure': 'Best Overall response rate (ORR) defined as the proportion of participants who achieved best response of superior to stable disease', 'timeFrame': 'Up to 12 Months'}]}, 'conditionsModule': {'keywords': ['Myelodysplastic syndromes (MDS)', 'Azacitidine (AZA)', 'Chronic myelomonocytic leukemia (CMML)', 'Acute myeloid leukemia (AML)'], 'conditions': ['Myelodysplastic Syndromes', 'Leukemia, Myelomonocytic, Chronic', 'Leukemia, Myeloid, Acute']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and effectiveness in the real-world setting among participants who are treated with Azacitidine in accordance with the China Product Label.', 'detailedDescription': 'This study will have participants both enrolled retrospectively and prospectively for azacitidine (AZA) treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of participants enrolled retrospectively, who initiate azacitidine (AZA) before enrollment and participants enrolled prospectively, who initiate AZA initiation at enrollment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented diagnosis of intermediate-2/ high-risk myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) or acute myeloid leukemia (AML) with 20-30% bone marrow blasts and multi-lineage dysplasia\n* Initiated azacitidine (AZA) treatment per approved China Product Label after April 2017\n\nExclusion Criteria:\n\n* Contraindicated for the use of AZA according to China Product Label\n* Simultaneously participating in a treatment intervention study\n\nOther protocol-defined inclusion/exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT05218902', 'acronym': 'DIM Vidaza', 'briefTitle': 'A Study of Azacitidine in Participants With International Prognostic Scoring System (IPSS) Intermediate-2 and High-risk Myelodysplastic Syndromes (MDS), or Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Prospective/Retrospective Non-Interventional Study of Vidaza® (Azacitidine) in Patients With International Prognostic Scoring System (IPSS) Intermediate-2 and High-risk Myelodysplastic Syndromes, or Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia With 20-30% Blasts and Multi-lineage Dysplasia in China', 'orgStudyIdInfo': {'id': 'CA055-016'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Retrospectively enrolled cohort', 'description': 'Participants who initiate Azacitidine (AZA) before enrollment'}, {'label': 'Prospectively enrolled cohort', 'description': 'Participants who initiate AZA initiation at enrollment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '300010', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Local Institution - 0001', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}