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)
NCT number | NCT03149055 |
Other study ID # | 17-112 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | May 4, 2017 |
Est. completion date | November 8, 2021 |
Verified date | November 2021 |
Source | Memorial Sloan Kettering Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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. |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center | Astellas Pharma US, Inc. |
United States,
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 |
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