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

Phase 2

Completed

• Conditions: Hematologic Malignancy; Myeloproliferative Disorder
• Interventions: Drug: Isavuconazole

• Registration Number: NCT03149055
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-04
• Study First Submitted: 2017-05-04
• Study First Submitted QC: 2017-05-09
• Study First Posted: 2017-05-11
• Primary Completion: 2019-08-20
• Results First Submitted: 2020-08-05
• Results First Submitted QC: 2020-08-05
• Results First Posted: 2020-08-20
• Status Verified: 2021-11
• Study Completion: 2021-11-08
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Isavuconazole prophylaxis	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. The minimum duration of prophylaxis with isavuconazole will be through D +60. Beyond day +60 discontinuation is at the discretion of the treating physician.

Primary Outcome Measures

Name	Time	Method
Clinical Failure of Isavuconazole Prophylaxis by Week + 26 Post Hematopoietic Stem Cell Transplant (HCT)	26 weeks post 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.
Clinical Failure of Isavuconazole Prophylaxis by Week + 14 Post Hematopoietic Stem Cell Transplant (HCT)	14 weeks post 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.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States