Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2025-12-28 @ 2:46 PM
Study NCT ID:
NCT05509933
Status:
RECRUITING
Last Update Posted:
2025-04-29
First Post:
2022-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Budesonide Prophylaxis for Engraftment Syndrome After Hematopoietic Cell Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019819', 'term': 'Budesonide'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2022-08-19', 'studyFirstSubmitQcDate': '2022-08-19', 'lastUpdatePostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'non-infectious fever', 'timeFrame': '30 days post stem cell transplant', 'description': 'non infectious fever defined as fever without identified infection that occurs up to 3 days prior and 10 days after the day of engraftment in patients on budesonide prophylaxis compared to patients who will not receive prophylaxis'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Engraftment Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if budesonide prophylaxis starting day 5 after transplant reduces engraftment fever in autologous and allogeneic stem cell transplant recipients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Patients 18-80 years of age with a diagnosis of a hematological malignancy\n\n * Meet the BMT program criteria to undergo hematopoietic stem cell transplantation for hematologi malignancies\n\nExclusion Criteria:\n\n* • Patients enrolled in investigational clinical trials\n\n * Sct for non hematologic malignancies'}, 'identificationModule': {'nctId': 'NCT05509933', 'briefTitle': 'Budesonide Prophylaxis for Engraftment Syndrome After Hematopoietic Cell Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Henry Ford Health System'}, 'officialTitle': 'Budesonide Prophylaxis for Engraftment Syndrome After Hematopoietic Cell Transplantation', 'orgStudyIdInfo': {'id': '15795'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Budesonide', 'interventionNames': ['Drug: Budesonide']}, {'type': 'NO_INTERVENTION', 'label': 'nothing'}], 'interventions': [{'name': 'Budesonide', 'type': 'DRUG', 'description': 'budesonide starting day 5 after transplant', 'armGroupLabels': ['Budesonide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'shatha farhan', 'role': 'CONTACT', 'email': 'sfarhan1@hfhs.org', 'phone': '313-916-5002'}], 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}], 'centralContacts': [{'name': 'shatha farhan', 'role': 'CONTACT', 'email': 'sfarhan1@hfhs.org', 'phone': '3137133910'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henry Ford Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Shatha Farhan', 'investigatorAffiliation': 'Henry Ford Health System'}}}}