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

NCT03149055 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 17-112
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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).

Conditions

Hematologic Malignancy; Myeloproliferative Disorder

Outcome Measures

Primary Outcomes (2)

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

  14 weeks post HCT

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

  26 weeks post HCT

Study Arms (1)

Isavuconazole prophylaxis

EXPERIMENTAL

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.

Drug: Isavuconazole

Interventions

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.

Also known as: Isavuconazonium sulfate

Isavuconazole prophylaxis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Astellas Pharma US, Inc.: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Hematologic Neoplasms; Myeloproliferative Disorders

Interventions

isavuconazole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Results Point of Contact

• Title: Genovefa Papanicolaou MD
• Organization: Memorial Sloan Kettering Cancer Center

papanicg@mskcc.org

212-639-8361

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 11, 2017
• Study Start: May 4, 2017
• Primary Completion: August 20, 2019
• Study Completion: November 8, 2021
• Last Updated: May 16, 2025
• Results First Posted: August 20, 2020

Record last verified: 2021-11

Locations

US (1)