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

Primary Purpose

Invasive Aspergillosis, Invasive Pulmonary Aspergillosis

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Investigational Agent: VL-2397
Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B
Sponsored by
Vical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Invasive Aspergillosis focused on measuring IA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham Hospital, Division of Infectious Diseases
  • UC San Diego Moores Cancer Center
  • UC Davis Health, Dept. of Internal Medicine, Div. of Infectious Diseases
  • Christiana Care Health Services, Department of Medicine
  • Medical College of Georgia at Augusta University
  • DMC Harper University Hospital
  • University of Minnesota, Department of Medicine
  • Washington University School of Medicine, Division of Infectious Disease
  • The University of Texas Health Science Center, Department of Internal Medicine
  • Fred Hutchinson Cancer Research Center (FHCRC)
  • Medical College of Wisconsin
  • University Hospital Antwerp (UZA), Department of Hematology
  • General Hospital Saint-Jan, Department of Hematology
  • Jules Bordet Institute, Department of Infectious Disease
  • University Hospitals Leuven, Campus Gasthuisberg, Department of Hematology
  • UCL Mont-Godinne University Hospitals, Department of Hematology
  • Hamilton Health Sciences, Infectious Disease Research
  • Toronto General Hospital
  • McGill University Health Centre (MUHC), Division of Infectios Diseases
  • Grenoble University Hospital Center, Department of Hematology
  • South Lyon Hospital Center
  • Hautepierre Hospital
  • University Hospital Jena
  • Hospital Neuperlach - Municipal Hospital Munich GmbH, Clinic of Hematology and Oncology
  • Chonnam National University
  • Samsung Medical Center
  • Seoul National University Hospital
  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

VL-2397

Standard (First-Line) Treatment

Arm Description

Investigational agent VL-2397 600 mg IV infusion administered every day for 28 days (4 weeks) followed by 2 weeks of standard treatment

Investigator selected standard treatments of voriconazole, isavuconazole, or liposomal amphotericin B administered every day for 42 days (6 weeks) per product package insert

Outcomes

Primary Outcome Measures

All-cause mortality (ACM)

Secondary Outcome Measures

ACM
Number of participants with adverse events
Number of participants with adverse events

Full Information

First Posted
October 27, 2017
Last Updated
February 25, 2019
Sponsor
Vical
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1. Study Identification

Unique Protocol Identification Number
NCT03327727
Brief Title
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Business decision
Study Start Date
February 20, 2018 (Actual)
Primary Completion Date
January 14, 2019 (Actual)
Study Completion Date
January 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Aspergillosis, Invasive Pulmonary Aspergillosis
Keywords
IA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The Sponsor, safety monitoring board, and data review committee are masked.
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VL-2397
Arm Type
Experimental
Arm Description
Investigational agent VL-2397 600 mg IV infusion administered every day for 28 days (4 weeks) followed by 2 weeks of standard treatment
Arm Title
Standard (First-Line) Treatment
Arm Type
Active Comparator
Arm Description
Investigator selected standard treatments of voriconazole, isavuconazole, or liposomal amphotericin B administered every day for 42 days (6 weeks) per product package insert
Intervention Type
Drug
Intervention Name(s)
Investigational Agent: VL-2397
Intervention Description
VL-2397
Intervention Type
Drug
Intervention Name(s)
Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B
Intervention Description
Voriconazole, Isavuconazole, or Liposomal amphotericin B
Primary Outcome Measure Information:
Title
All-cause mortality (ACM)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
ACM
Time Frame
6 weeks
Title
Number of participants with adverse events
Description
Number of participants with adverse events
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mammen P Mammen, MD, FIDSA
Organizational Affiliation
Vical
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham Hospital, Division of Infectious Diseases
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
UC Davis Health, Dept. of Internal Medicine, Div. of Infectious Diseases
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Christiana Care Health Services, Department of Medicine
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Medical College of Georgia at Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
DMC Harper University Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
University of Minnesota, Department of Medicine
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Washington University School of Medicine, Division of Infectious Disease
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
The University of Texas Health Science Center, Department of Internal Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center (FHCRC)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
University Hospital Antwerp (UZA), Department of Hematology
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
General Hospital Saint-Jan, Department of Hematology
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Jules Bordet Institute, Department of Infectious Disease
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
University Hospitals Leuven, Campus Gasthuisberg, Department of Hematology
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
UCL Mont-Godinne University Hospitals, Department of Hematology
City
Yvoir
ZIP/Postal Code
B-5530
Country
Belgium
Facility Name
Hamilton Health Sciences, Infectious Disease Research
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
McGill University Health Centre (MUHC), Division of Infectios Diseases
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Grenoble University Hospital Center, Department of Hematology
City
Grenoble
ZIP/Postal Code
38700
Country
France
Facility Name
South Lyon Hospital Center
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Facility Name
Hautepierre Hospital
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Facility Name
University Hospital Jena
City
Jena
ZIP/Postal Code
07740
Country
Germany
Facility Name
Hospital Neuperlach - Municipal Hospital Munich GmbH, Clinic of Hematology and Oncology
City
Munich
ZIP/Postal Code
81737
Country
Germany
Facility Name
Chonnam National University
City
Hwasun
ZIP/Postal Code
519-809
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
11 0-744
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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