Back to resultsFungal Prophylaxis With Isavuconazole for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (HCT)
Primary Purpose
Hematologic Malignancy, Myeloproliferative Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Isavuconazole
Sponsored by
About this trial
This is an interventional treatment trial for Hematologic Malignancy
Eligibility Criteria
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.
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Isavuconazole prophylaxis
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03149055
First Posted
May 4, 2017
Last Updated
November 15, 2021
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Astellas Pharma US, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03149055
Brief Title
Fungal Prophylaxis With Isavuconazole for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (HCT)
Official Title
A Single Center, Open-label Trial of Isavuconazole Prophylaxis Against Invasive Fungal Infection in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (HCT)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
May 4, 2017 (Actual)
Primary Completion Date
August 20, 2019 (Actual)
Study Completion Date
November 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Astellas Pharma US, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancy, Myeloproliferative Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Isavuconazole prophylaxis
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Isavuconazole
Other Intervention Name(s)
Isavuconazonium sulfate
Intervention Description
Intravenous or oral: Isavuconazonium sulfate 372 mg Q 8hour for 6 doses as loading dose, followed by 372 mg Q day as maintenance dose.
Primary Outcome Measure Information:
Title
Clinical Failure of Isavuconazole Prophylaxis by Week + 14 Post Hematopoietic Stem Cell Transplant (HCT)
Description
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.
Time Frame
14 weeks post HCT
Title
Clinical Failure of Isavuconazole Prophylaxis by Week + 26 Post Hematopoietic Stem Cell Transplant (HCT)
Description
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.
Time Frame
26 weeks post HCT
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
Fungal Prophylaxis With Isavuconazole for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (HCT)
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