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

Memorial Sloan Kettering Cancer Center99 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hematologic Malignancy Myeloproliferative Disorder

Interventions

IsavuconazoleDRUG

Intravenous or oral: Isavuconazonium sulfate 372 mg Q 8hour for 6 doses as loading dose, followed by 372 mg Q day as maintenance dose.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Outcomes

Primary Outcomes

Clinical Failure of Isavuconazole Prophylaxis by Week + 14 Post Hematopoietic Stem Cell Transplant (HCT)

Clinical failure is measured by: 1. Systemic antifungal therapy for \> 14 consecutive days for suspected fungal infection up to week 14. 2. Breakthrough proven or probable fungal infection during the prophylaxis phase.\* 3. Toxicity leading to permanent discontinuation of prophylaxis 4. 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.

Time frame: 14 weeks post HCT

Clinical Failure of Isavuconazole Prophylaxis by Week + 26 Post Hematopoietic Stem Cell Transplant (HCT)

Time frame: 26 weeks post HCT

Data from ClinicalTrials.gov

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