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

Hematologic Malignancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03149055
• Other study ID #: 17-112
• Status: Completed
• Phase: Phase 2
• Start date: May 4, 2017
• Est. completion date: November 8, 2021

Study information

• Verified date: November 2021
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: November 8, 2021
• Est. primary completion date: August 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Malignancy
• Hematologic Neoplasms
• Myeloproliferative Disorder
• Myeloproliferative Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Astellas Pharma US, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center