Clinical trial NCT03327727: VL-2397 Compared to Standard First-Line Treatment for Invasive Aspergillosis (IA) in Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Invasive Aspergillosis
Invasive Pulmonary Aspergillosis
Keywords: IA
Lead sponsor: Vical
Sponsor class: INDUSTRY
First posted: 2017-10-31
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: All-cause mortality (ACM)
timeFrame: 4 weeks
Secondary outcomes:
measure: ACM
timeFrame: 6 weeks
measure: Number of participants with adverse events
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Hospital, Division of Infectious Diseases
state: Alabama
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
city: Sacramento
country: United States
facility: UC Davis Health, Dept. of Internal Medicine, Div. of Infectious Diseases
state: California
city: Newark
country: United States
facility: Christiana Care Health Services, Department of Medicine
state: Delaware
city: Augusta
country: United States
facility: Medical College of Georgia at Augusta University
state: Georgia
city: Detroit
country: United States
facility: DMC Harper University Hospital
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota, Department of Medicine
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine, Division of Infectious Disease
state: Missouri
city: Houston
country: United States
facility: The University of Texas Health Science Center, Department of Internal Medicine
state: Texas
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center (FHCRC)
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Edegem
country: Belgium
facility: University Hospital Antwerp (UZA), Department of Hematology
state: Antwerp
city: Brugge
country: Belgium
facility: General Hospital Saint-Jan, Department of Hematology
city: Brussels
country: Belgium
facility: Jules Bordet Institute, Department of Infectious Disease
city: Leuven
country: Belgium
facility: University Hospitals Leuven, Campus Gasthuisberg, Department of Hematology
city: Yvoir
country: Belgium
facility: UCL Mont-Godinne University Hospitals, Department of Hematology
city: Hamilton
country: Canada
facility: Hamilton Health Sciences, Infectious Disease Research
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montréal
country: Canada
facility: McGill University Health Centre (MUHC), Division of Infectios Diseases
state: Quebec
city: Grenoble
country: France
facility: Grenoble University Hospital Center, Department of Hematology
city: Pierre-Bénite
country: France
facility: South Lyon Hospital Center
city: Strasbourg
country: France
facility: Hautepierre Hospital
city: Jena
country: Germany
facility: University Hospital Jena
city: Munich
country: Germany
facility: Hospital Neuperlach - Municipal Hospital Munich GmbH, Clinic of Hematology and Oncology
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Vical
name: Mammen P Mammen, MD, FIDSA
role: STUDY_DIRECTOR
References: