Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-01-01 @ 1:01 AM
Study NCT ID:
NCT07069933
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-17
First Post:
2025-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Repurposing Itraconazole as an Adjuvant Therapy in Treatment of Patients With Acute Myeloid Leukemia: Is it a Hopeful Avenue for Enhancing Treatment Options?
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': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2025-02-14', 'studyFirstSubmitQcDate': '2025-07-16', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of blasts in bone marrow at d21 after induction', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'A prospective, randomized, controlled, parallel clinical trial will be conducted at Clinical Oncology and Nuclear Medicine Center at Mansoura University Hospital to assess the efficacy of Itraconazole as an adjuvant therapy in treatment of patients with acute myeloid Leukemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with Acute Myeloid leukemia, and aged 18 years or older\n2. Patients whose ECOG performance status ranged from 0-2 and are fit for all treatments protocols\n\nExclusion Criteria:\n\n1. Patients with any other types of malignancies rather than Leukemia and patients.\n2. Patients with history alcohol intake, acute or chronic.\n3. Patients with documented hypersensitivity or allergy to Itraconazole.\n4. Patients suffer from chronic heart failure\n5. Patients present with severe dehydration.\n6. Patients with severe kidney dysfunction'}, 'identificationModule': {'nctId': 'NCT07069933', 'briefTitle': 'Repurposing Itraconazole as an Adjuvant Therapy in Treatment of Patients With Acute Myeloid Leukemia: Is it a Hopeful Avenue for Enhancing Treatment Options?', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': '"Repurposing Itraconazole as an Adjuvant Therapy in Treatment of Patients With Acute Myeloid Leukemia: Is it a Hopeful Avenue for Enhancing Treatment Options?"', 'orgStudyIdInfo': {'id': '2024-42-2024-120'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control arm', 'description': 'Standard Care', 'interventionNames': ['Drug: Chemotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Interventional arm', 'description': 'Standard Care plus itraconazole', 'interventionNames': ['Drug: Standard care +itraconazole 200mg']}], 'interventions': [{'name': 'Standard care +itraconazole 200mg', 'type': 'DRUG', 'description': 'Is an antifungal used to treat a variety of fungal infections. It belongs to a class of drugs known as azole antifungals.', 'armGroupLabels': ['Interventional arm']}, {'name': 'Chemotherapy', 'type': 'DRUG', 'description': 'Standard Care (in control arm)', 'armGroupLabels': ['Control arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Clinical Oncology and Nuclear Medicine of Mansoura University Hospital, Mansoura,', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Gayda A.R. Abuhammad, MSc', 'role': 'CONTACT', 'email': 'gaydaabuhammad1997@gmail.com', 'phone': '+962798241327'}], 'overallOfficials': [{'name': 'Mohamed el-Husseiny shams', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor Department of Clinical pharmacy and Pharmacy practice, Faculty of Pharmacy, Mansoura University'}, {'name': 'Moetaza Mahmoud Hassab Soliman', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Associate professor of Clinical Pharmacy, Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura University'}, {'name': 'Noha Osama Mansour Mansour', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lecturer of Clinical Pharmacy, Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura University'}, {'name': 'Sara Mohamed Ali Atwa', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lecturer of Medical Oncology, Department of Internal Medicine, Faculty of Medicine, Mansoura University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Clinical Pharmacy and Pharmacy Practice', 'investigatorFullName': 'Noha Mansour', 'investigatorAffiliation': 'Mansoura University'}}}}