Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-25 @ 4:02 PM
Study NCT ID:
NCT04887857
Status:
COMPLETED
Last Update Posted:
2024-02-12
First Post:
2021-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000709231', 'term': 'cc-486'}, {'id': 'D001374', 'term': 'Azacitidine'}, {'id': 'C579720', 'term': 'venetoclax'}], 'ancestors': [{'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT03723135', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-09', 'studyFirstSubmitDate': '2021-05-11', 'studyFirstSubmitQcDate': '2021-05-11', 'lastUpdatePostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD)', 'timeFrame': 'Up to 42 days after first dose'}, {'measure': 'Incidence of type of adverse events (AEs)', 'timeFrame': 'From informed consent form (ICF) signature to 28 days after last dose of study drug'}, {'measure': 'Incidence of frequency of AEs', 'timeFrame': 'From informed consent form (ICF) signature to 28 days after last dose of study drug'}, {'measure': 'Incidence of severity of AEs', 'timeFrame': 'From informed consent form (ICF) signature to 28 days after last dose of study drug'}, {'measure': 'Incidence of relationship of AEs to study treatment', 'timeFrame': 'From informed consent form (ICF) signature to 28 days after last dose of study drug'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory results: Hematology tests', 'timeFrame': 'From informed consent form (ICF) signature to 28 days after last dose of study drug'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests', 'timeFrame': 'From informed consent form (ICF) signature to 28 days after last dose of study drug'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests', 'timeFrame': 'From informed consent form (ICF) signature to 28 days after last dose of study drug'}], 'secondaryOutcomes': [{'measure': 'Rate of complete remission (CR)/complete remission with partial hematologic recovery (CRh)', 'timeFrame': 'Up to approximately 12 months'}, {'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'Up to approximately 12 months'}, {'measure': 'Minimal Residual Disease (MRD) Response Rate', 'timeFrame': 'Up to approximately 12 months'}, {'measure': 'MRD Conversion Rate', 'timeFrame': 'Up to approximately 12 months'}, {'measure': 'Rate of complete remission (CR)/complete remission with incomplete recovery of blood counts (CRi)', 'timeFrame': 'Up to approximately 12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Myeloid Leukemia', 'CC-486', 'Onureg', 'oral azacitidine', 'venetoclax', 'Venclexta', 'Venclyxto'], 'conditions': ['Leukemia, Myeloid, Acute']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bmsstudyconnect.com/content/studyconnect/us/en/clinical-trials/NCT04887857.html', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-486 (ONUREG®) in combination with venetoclax in relapsed and/or refractory Acute Myeloid Leukemia (AML) and newly diagnosed AML.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmation of the following for Acute Myeloid Leukemia (AML)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. ECOG 3 is allowed if participants are 18 to 74 years old with comorbidities\n* Agree to serial bone marrow aspirate/biopsies\n\nExclusion Criteria:\n\n* Suspected or proven to have acute promyelocytic leukemia based on morphology, immunophenotype, molecular assay, or karyotype\n* Received prior hypomethylating agent (HMA) therapy for myelodysplastic syndromes/Chronic myelomonocytic leukemia then develop AML within 4 months of discontinuing the HMA therapy\n* Prior history of malignancy unless the participant has been free of the disease for ≥ 1 year prior to the start of study treatment\n\nOther protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT04887857', 'acronym': 'OMNIVERSE', 'briefTitle': 'A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celgene'}, 'officialTitle': 'A Phase 1B, Open-label, Global, Multicenter, Dose Determination Study to Evaluate Safety, Tolerability, and Preliminary Efficacy of CC-486 (ONUREG®) in Combination Therapy in Subjects With Acute Myeloid Leukemia (AML)', 'orgStudyIdInfo': {'id': 'CC-486-AML-004'}, 'secondaryIdInfos': [{'id': '2020-004941-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CC-486 in combination with Venetoclax', 'interventionNames': ['Drug: CC-486', 'Drug: Venetoclax']}], 'interventions': [{'name': 'CC-486', 'type': 'DRUG', 'otherNames': ['ONUREG®, oral azacitidine'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['CC-486 in combination with Venetoclax']}, {'name': 'Venetoclax', 'type': 'DRUG', 'otherNames': ['VENCLEXTA®, VENCLYXTO®'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['CC-486 in combination with Venetoclax']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305-5317', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution - 104', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Local Institution - 110', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Local Institution - 105', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Local Institution - 106', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Local Institution - 113', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Local Institution - 102', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Local Institution - 111', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '77003', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Local Institution - 101', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '3002', 'city': 'North Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Local Institution - 202', 'geoPoint': {'lat': -37.79798, 'lon': 144.94512}}, {'zip': '3004', 'city': 'Melbourne', 'country': 'Australia', 'facility': 'Local Institution - 201', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'ipdSharingStatementModule': {'url': 'https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'See Plan Description', 'ipdSharing': 'YES', 'description': 'Information relating to our policy on data sharing and the process for requesting data can be found at the following link:\n\nhttps://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/', 'accessCriteria': 'See Plan Description'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celgene', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'AbbVie', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}