Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2025-12-31 @ 6:21 PM
Study NCT ID:
NCT05627466
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2024-02-15
First Post:
2022-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
US Expanded Access Program for Magrolimab in Patients With Relapsed or Refractory Acute Myeloid Leukemia
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': 'C000629291', 'term': 'magrolimab'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'intermediate': True}, 'nPtrsToThisExpAccNctId': 4}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'lastUpdateSubmitDate': '2024-02-13', 'studyFirstSubmitDate': '2022-11-16', 'studyFirstSubmitQcDate': '2022-11-16', 'lastUpdatePostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Relapsed/Refractory Acute Myeloid Leukemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.yourpatientaccess.com', 'label': 'Click on this link to request access through the Bionical Emas Patient Access Portal'}, {'url': 'https://www.gileadclinicaltrials.com/study/?id=GS-US-546-6531', 'label': 'Gilead Clinical Trials Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this expanded access program is to provide rapid access to magrolimab free-of-cost material, to treat patients in the United States suffering from relapsed or refractory acute myeloid leukemia (AML).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Individuals with confirmation of acute myeloid leukemia (AML) according to WHO 2016 classification who are refractory or relapsed, ineligible for all known drugs with proven efficacy, and ineligible for existing clinical studies; and the treating physician has assessed that the potential benefits of magrolimab outweigh the risks.\n* Eastern Cooperative Oncology Group performance status score of 0 to 3.\n* Treating physician plans to administer magrolimab in combination with azacitadine/venetoclax or magrolimab in combination with azacitadine alone, following the indication-specific combinations described in the protocol.\n\nKey Exclusion Criteria:\n\n* Known hypersensitivity to magrolimab, azacitidine, venetoclax, their metabolites, or formulation excipients, if applicable to planned treatment regimen.\n* Prior treatment with cluster of differentiation (CD)47 or signal regulatory protein alpha (SIRPĪ±)-targeting agents.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT05627466', 'briefTitle': 'US Expanded Access Program for Magrolimab in Patients With Relapsed or Refractory Acute Myeloid Leukemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'Expanded Access Program for Magrolimab', 'orgStudyIdInfo': {'id': 'GS-US-546-6531'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Magrolimab', 'type': 'DRUG', 'otherNames': ['GS-4721'], 'description': 'Administered intravenously'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gilead Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}