Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-31 @ 3:44 AM
Study NCT ID:
NCT04678466
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2022-05-31
First Post:
2020-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Flotetuzumab Expanded Access Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D012008', 'term': 'Recurrence'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}, 'nPtrsToThisExpAccNctId': 1}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'lastUpdateSubmitDate': '2022-05-24', 'studyFirstSubmitDate': '2020-12-16', 'studyFirstSubmitQcDate': '2020-12-16', 'lastUpdatePostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Acute Myeloid Leukemia', 'AML', 'AML, Adult Recurrent']}, 'descriptionModule': {'briefSummary': 'The purpose of the Expanded Access program is to provide flotetuzumab to patients with acute myeloid leukemia (AML) for whom potential benefit justifies potential treatment risks.', 'detailedDescription': 'MacroGenics will consider, on a case-by-case basis, requests by treating physicians to file a single patient investigational new drug application for expanded access to flotetuzumab and for MacroGenics to supply flotetuzumab for single patient use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Weight of at least 17 kilograms\n* CD123-positive hematologic malignancy\n* Adequate organ reserve\n* Provider and site are trained on study protocol using flotetuzumab\n\nExclusion Criteria:\n\n* AML that meets inclusion criteria for study CP-MGD006-01 (NCT02152956)\n* Primary induction failure\n* Early relapse (less than 6 months after first complete remission )\n* Three prior lines of therapy, including maximum of 1 prior salvage attempts'}, 'identificationModule': {'nctId': 'NCT04678466', 'briefTitle': 'Flotetuzumab Expanded Access Program', 'organization': {'class': 'INDUSTRY', 'fullName': 'MacroGenics'}, 'officialTitle': 'An Expanded Access Program Providing Flotetuzumab in the Treatment of Acute Myeloid Leukemia Patients in Single, Individually-approved Patients', 'orgStudyIdInfo': {'id': 'MGD006-EA'}}, 'armsInterventionsModule': {'interventions': [{'name': 'flotetuzumab', 'type': 'BIOLOGICAL', 'otherNames': ['MGD006'], 'description': 'CD123 x CD3 bispecific DART® antibody'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ashley Ward, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MacroGenics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MacroGenics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}