Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-02-20 @ 10:09 PM
Study NCT ID:
NCT03723135
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2020-09-18
First Post:
2018-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access for CC-486
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'}], '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': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}, 'nPtrsToThisExpAccNctId': 9}, 'statusModule': {'overallStatus': 'APPROVED_FOR_MARKETING', 'statusVerifiedDate': '2020-09', 'lastUpdateSubmitDate': '2020-09-16', 'studyFirstSubmitDate': '2018-10-25', 'studyFirstSubmitQcDate': '2018-10-25', 'lastUpdatePostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Expanded Access', 'Compassionate Use'], 'conditions': ['Acute Myelogenous Leukemia (AML)']}, 'descriptionModule': {'briefSummary': 'This is an expanded access program (EAP) for eligible participants designed to provide access to CC-486.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Adult patients with documented acute myelogenous leukemia (AML) in their first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment, who seek treatment with CC-486 as monotherapy to maintain their CR or CRi.\n\nExclusion Criteria:\n\n* Patients with AML in CR/CRi who plan to proceed to or are waiting for a bone marrow transplant\n* Patients who have received a bone marrow transplant for the treatment of AML\n* Treatment of AML patients with relapse or refractory disease\n* Pregnant or breast-feeding females\n* Patient meets enrollment criteria and can participate in a disease-specific clinical trial'}, 'identificationModule': {'nctId': 'NCT03723135', 'briefTitle': 'Expanded Access for CC-486', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celgene'}, 'officialTitle': 'Expanded Access for CC-486', 'orgStudyIdInfo': {'id': 'CC-486'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CC-486', 'type': 'DRUG', 'otherNames': ['Oral Azacitidine'], 'description': 'Oral azacitidine administered as directed by treating physician.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07901', 'city': 'Summit', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Celgene', 'geoPoint': {'lat': 40.71562, 'lon': -74.36468}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celgene', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}