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

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ClinicalTrials.gov Identifier: NCT03149055
Recruitment Status : Recruiting
First Posted : May 11, 2017
Last Update Posted : October 4, 2018
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Hematologic Malignancy Myeloproliferative Disorder Drug: Isavuconazole Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Center, Open-label Trial of Isavuconazole Prophylaxis Against Invasive Fungal Infection in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (HCT)
Actual Study Start Date : May 4, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019


Arm Intervention/treatment
Experimental: Isavuconazole prophylaxis
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
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 Name: Isavuconazonium sulfate




Primary Outcome Measures :
  1. To evaluate the clinical failure rate by week + 14 post HCT of isavuconazole prophylaxis per protocol . [ Time Frame: 14 weeks ]

    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. The prophylaxis phase is defined as the period from the first dose of isavuconazole through 7 days after discontinuation
    3. Toxicity leading to permanent discontinuation of prophylaxis
    4. Adverse event requiring discontinuation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03149055


Contacts
Contact: Genovefa Papanicolaou, MD 212-639-8361 papanicg@mskcc.org
Contact: Yeon Joo Lee, MD 212-639-8180

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Genovefa Papanicolaou, MD    212-639-8361      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Astellas Pharma US, Inc.

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03149055     History of Changes
Other Study ID Numbers: 17-112
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Myeloproliferative Disorders
Invasive Fungal Infections
Bone Marrow Diseases
Hematologic Diseases
Mycoses