Skip to main content
OpenTrials
Completed

NCT Number: NCT03149055

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hematologic Malignancy Bone Marrow Diseases Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Myeloproliferative Disorder Myeloproliferative Disorders Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Isavuconazole

Drug

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

Other names: Isavuconazonium sulfate

Primary outcomes

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

    Time frame: 14 weeks post 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.

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

    Time frame: 26 weeks post 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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Astellas Pharma US, Inc.

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
May 11, 2017
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.