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A Phase 2 Study of VL-2397 Compared to Standard First-Line Treatment for Invasive Aspergillosis in Adults With Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, or Allogeneic Hematopoietic Cell Transplant Recipients
The purpose of the trial is to evaluate the safety and efficacy of a new antifungal with a novel mechanism of action in immunocompromised adults with invasive aspergillosis.
To compare the safety and efficacy of VL-2397 to standard first-line treatment for invasive aspergillosis in immunocompromised adults with acute leukemia or recipients of an allogeneic hematopoietic cell transplant (allo-HCT).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Alabama at Birmingham Hospital, Division of Infectious Diseases
Birmingham, Alabama, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
UC Davis Health, Dept. of Internal Medicine, Div. of Infectious Diseases
Sacramento, California, United States
Christiana Care Health Services, Department of Medicine
Newark, Delaware, United States
Medical College of Georgia at Augusta University
Augusta, Georgia, United States
DMC Harper University Hospital
Detroit, Michigan, United States
University of Minnesota, Department of Medicine
Minneapolis, Minnesota, United States
Washington University School of Medicine, Division of Infectious Disease
St Louis, Missouri, United States
The University of Texas Health Science Center, Department of Internal Medicine
Houston, Texas, United States
Fred Hutchinson Cancer Research Center (FHCRC)
Seattle, Washington, United States
Start Date
February 20, 2018
Primary Completion Date
January 14, 2019
Completion Date
January 14, 2019
Last Updated
February 27, 2019
4
ACTUAL participants
Investigational Agent: VL-2397
DRUG
Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B
DRUG
Lead Sponsor
Vical
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03717623