Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-26 @ 1:41 PM
Study NCT ID:
NCT05619367
Status:
AVAILABLE
Last Update Posted:
2025-12-23
First Post:
2022-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Compassionate Use (CU) Program of Odronextamab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}}, 'statusModule': {'overallStatus': 'AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2022-11-08', 'studyFirstSubmitQcDate': '2022-11-08', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Relapsed or Refractory (R/R) Follicular Lymphoma (FL)', 'Diffuse Large B-Cell Lymphoma (DLBCL)', 'B-Cell Non-Hodgkin Lymphoma (NHL)', 'High-Grade B-Cell Lymphoma (HGBCL)']}, 'descriptionModule': {'briefSummary': 'Provide compassionate use of odronextamab'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT']}, 'identificationModule': {'nctId': 'NCT05619367', 'briefTitle': 'A Compassionate Use (CU) Program of Odronextamab', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'orgStudyIdInfo': {'id': 'R1979-Odronextamab'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Odronextamab', 'type': 'DRUG', 'otherNames': ['REGN1979']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Requests for compassionate use must be initiated by a treating physician Physicians should contact', 'role': 'CONTACT', 'email': 'CompassionateUseRequests@regeneron.com', 'phone': '844-734-6643'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}