Fungal Prophylaxis With Isavuconazole for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (HCT)

Study Overview
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Brief Summary
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The purpose of this study is to study the effects of isavuconazole in preventing fungal infections in patients who have had a hematopoietic stem cell transplant (HCT).

Official Title
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A Single Center, Open-label Trial of Isavuconazole Prophylaxis Against Invasive Fungal Infection in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (HCT)

Conditions
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Hematologic Malignancy, Myeloproliferative Disorder

Intervention / Treatment
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* Drug: Isavuconazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects of greater than or equal to 18 years of age of either sex and of any race. Have received first peripheral blood, marrow or cord blood transplant from a family or unrelated donor for hematologic malignancy or myeloproliferative disorder. Exclusion Criteria: Proven or probable aspergillosis or other mold infection or deep mycoses including hepatosplenic candidiasis less than 60 days from first dose of ISA. History of allergy or intolerance to ISA. Clinically significant elevation of liver function tests prior to the first day of dosing (FDD) that at the discretion of the treating physician would preclude the administration of an azole antifungal. Familial short QT syndrome.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Isavuconazole prophylaxis<br>Intravenous or oral: Isavuconazonium sulfate 372 mg Q 8hour for 6 doses as loading dose, followed by 372 mg Q day as maintenance dose. The minimum duration of prophylaxis with isavuconazole will be through D +60. Beyond day +60 discontinuation is at the discretion of the treating physician. | Drug: Isavuconazole<br>* Intravenous or oral: Isavuconazonium sulfate 372 mg Q 8hour for 6 doses as loading dose, followed by 372 mg Q day as maintenance dose.<br>* Other names: Isavuconazonium sulfate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Failure of Isavuconazole Prophylaxis by Week + 14 Post Hematopoietic Stem Cell Transplant (HCT) | Clinical failure is measured by: Systemic antifungal therapy for > 14 consecutive days for suspected fungal infection up to week 14. Breakthrough proven or probable fungal infection during the prophylaxis phase.* Toxicity leading to permanent discontinuation of prophylaxis Adverse event requiring discontinuation. The prophylaxis phase was defined as the period from the first dose of isavuconazole through 7 days after discontinuation of isavuconazole. | 14 weeks post HCT | 
| Clinical Failure of Isavuconazole Prophylaxis by Week + 26 Post Hematopoietic Stem Cell Transplant (HCT) | Clinical failure is measured by: Systemic antifungal therapy for > 14 consecutive days for suspected fungal infection up to week 14. Breakthrough proven or probable fungal infection during the prophylaxis phase.* Toxicity leading to permanent discontinuation of prophylaxis Adverse event requiring discontinuation. The prophylaxis phase was defined as the period from the first dose of isavuconazole through 7 days after discontinuation of isavuconazole. | 26 weeks post HCT |