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

Invasive Aspergillosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03327727
• Other study ID #: VL2397-201
• Secondary ID: 2017-003435-11
• Status: Terminated
• Phase: Phase 2
• Start date: February 20, 2018
• Est. completion date: January 14, 2019

Study information

• Verified date: February 2019
• Source: Vical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: January 14, 2019
• Est. primary completion date: January 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aspergillosis
• Invasive Aspergillosis
• Invasive Pulmonary Aspergillosis
• Pulmonary Aspergillosis

Intervention

Drug:
• Investigational Agent: VL-2397
VL-2397
• Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B
Voriconazole, Isavuconazole, or Liposomal amphotericin B

Locations

Country	Name	City	State
Belgium	General Hospital Saint-Jan, Department of Hematology	Brugge
Belgium	Jules Bordet Institute, Department of Infectious Disease	Brussels
Belgium	University Hospital Antwerp (UZA), Department of Hematology	Edegem	Antwerp
Belgium	University Hospitals Leuven, Campus Gasthuisberg, Department of Hematology	Leuven
Belgium	UCL Mont-Godinne University Hospitals, Department of Hematology	Yvoir
Canada	Hamilton Health Sciences, Infectious Disease Research	Hamilton	Ontario
Canada	McGill University Health Centre (MUHC), Division of Infectios Diseases	Montréal	Quebec
Canada	Toronto General Hospital	Toronto	Ontario
France	Grenoble University Hospital Center, Department of Hematology	Grenoble
France	South Lyon Hospital Center	Pierre-Bénite
France	Hautepierre Hospital	Strasbourg
Germany	University Hospital Jena	Jena
Germany	Hospital Neuperlach - Municipal Hospital Munich GmbH, Clinic of Hematology and Oncology	Munich
Korea, Republic of	Chonnam National University	Hwasun
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
United States	Medical College of Georgia at Augusta University	Augusta	Georgia
United States	University of Alabama at Birmingham Hospital, Division of Infectious Diseases	Birmingham	Alabama
United States	DMC Harper University Hospital	Detroit	Michigan
United States	The University of Texas Health Science Center, Department of Internal Medicine	Houston	Texas
United States	UC San Diego Moores Cancer Center	La Jolla	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota, Department of Medicine	Minneapolis	Minnesota
United States	Christiana Care Health Services, Department of Medicine	Newark	Delaware
United States	UC Davis Health, Dept. of Internal Medicine, Div. of Infectious Diseases	Sacramento	California
United States	Washington University School of Medicine, Division of Infectious Disease	Saint Louis	Missouri
United States	Fred Hutchinson Cancer Research Center (FHCRC)	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Vical

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality (ACM)		4 weeks
Secondary	ACM		6 weeks
Secondary	Number of participants with adverse events	Number of participants with adverse events	6 weeks