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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm | Other | Standard Care |
|
| Interventional arm | Active Comparator | Standard Care plus itraconazole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard care +itraconazole 200mg | Drug | Is an antifungal used to treat a variety of fungal infections. It belongs to a class of drugs known as azole antifungals. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of blasts in bone marrow at d21 after induction | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gayda A.R. Abuhammad, MSc | Contact | +962798241327 | gaydaabuhammad1997@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed el-Husseiny shams | Professor Department of Clinical pharmacy and Pharmacy practice, Faculty of Pharmacy, Mansoura University | Principal Investigator |
| Moetaza Mahmoud Hassab Soliman | Associate professor of Clinical Pharmacy, Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura University |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Oncology and Nuclear Medicine of Mansoura University Hospital, Mansoura, | Al Mansurah | Egypt |
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| Chemotherapy | Drug | Standard Care (in control arm) |
|
| Study Director |
| Noha Osama Mansour Mansour | Lecturer of Clinical Pharmacy, Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura University | Study Director |
| Sara Mohamed Ali Atwa | Lecturer of Medical Oncology, Department of Internal Medicine, Faculty of Medicine, Mansoura University | Study Director |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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