VL-2397 Compared to Standard First-Line Treatment for Invasive Aspergillosis (IA) in Adults

Phase 2

Terminated

• Conditions: Invasive Pulmonary Aspergillosis; Invasive Aspergillosis

• Registration Number: NCT03327727
• Lead Sponsor: Vical

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study First Submitted: 2017-10-27
• Study First Submitted QC: 2017-10-30
• Study First Posted: 2017-10-31
• Study Start: 2018-02-20
• Primary Completion: 2019-01-14
• Study Completion: 2019-01-14
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Acute Leukemia (AML or ALL) patient or allo-HCT recipient with a diagnosis of IA

Exclusion Criteria

• Pregnant or breastfeeding
• IA involving sites other than lungs and sinuses
• Graft failure, acute or extensive chronic GvHD
• Uncontrolled diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
All-cause mortality (ACM)	4 weeks

Secondary Outcome Measures

Name	Time	Method
ACM	6 weeks
Number of participants with adverse events	6 weeks	Number of participants with adverse events

Trial Locations

Locations (28)

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

University of Minnesota, Department of Medicine; 🇺🇸 Minneapolis, Minnesota, United States

DMC Harper University Hospital; 🇺🇸 Detroit, Michigan, United States

Washington University School of Medicine, Division of Infectious Disease; 🇺🇸 Saint Louis, Missouri, United States

Medical College of Georgia at Augusta University; 🇺🇸 Augusta, Georgia, United States

Fred Hutchinson Cancer Research Center (FHCRC); 🇺🇸 Seattle, Washington, United States

The University of Texas Health Science Center, Department of Internal Medicine; 🇺🇸 Houston, Texas, United States

University Hospitals Leuven, Campus Gasthuisberg, Department of Hematology; 🇧🇪 Leuven, Belgium

Hamilton Health Sciences, Infectious Disease Research; 🇨🇦 Hamilton, Ontario, Canada

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

McGill University Health Centre (MUHC), Division of Infectios Diseases; 🇨🇦 Montréal, Quebec, Canada

Grenoble University Hospital Center, Department of Hematology; 🇫🇷 Grenoble, France

University Hospital Jena; 🇩🇪 Jena, Germany

South Lyon Hospital Center; 🇫🇷 Pierre-Bénite, France

Hautepierre Hospital; 🇫🇷 Strasbourg, France

Hospital Neuperlach - Municipal Hospital Munich GmbH, Clinic of Hematology and Oncology; 🇩🇪 Munich, Germany

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Chonnam National University; 🇰🇷 Hwasun, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Christiana Care Health Services, Department of Medicine; 🇺🇸 Newark, Delaware, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

University Hospital Antwerp (UZA), Department of Hematology; 🇧🇪 Edegem, Antwerp, Belgium

UCL Mont-Godinne University Hospitals, Department of Hematology; 🇧🇪 Yvoir, Belgium

General Hospital Saint-Jan, Department of Hematology; 🇧🇪 Brugge, Belgium

Jules Bordet Institute, Department of Infectious Disease; 🇧🇪 Brussels, Belgium