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

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.

Study Overview

• Status: Terminated
• Conditions: Invasive Aspergillosis; Invasive Pulmonary Aspergillosis
• Intervention / Treatment: Drug: Investigational Agent: VL-2397; Drug: Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Brugge, Belgium, 8000
    • General Hospital Saint-Jan, Department of Hematology
  • Brussels, Belgium, 1000
    • Jules Bordet Institute, Department of Infectious Disease
  • Leuven, Belgium, 3000
    • University Hospitals Leuven, Campus Gasthuisberg, Department of Hematology
  • Yvoir, Belgium, B-5530
    • UCL Mont-Godinne University Hospitals, Department of Hematology
  • Antwerp
    • Edegem, Antwerp, Belgium, B-2650
      • University Hospital Antwerp (UZA), Department of Hematology
• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8V 1C3
      • Hamilton Health Sciences, Infectious Disease Research
    • Toronto, Ontario, Canada, M5G 2N2
      • Toronto General Hospital
  • Quebec
    • Montréal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre (MUHC), Division of Infectios Diseases
• France
  • Grenoble, France, 38700
    • Grenoble University Hospital Center, Department of Hematology
  • Pierre-Bénite, France, 69310
    • South Lyon Hospital Center
  • Strasbourg, France, 67200
    • Hautepierre Hospital
• Germany
  • Jena, Germany, 07740
    • University Hospital Jena
  • Munich, Germany, 81737
    • Hospital Neuperlach - Municipal Hospital Munich GmbH, Clinic of Hematology and Oncology
• Korea, Republic of
  • Hwasun, Korea, Republic of, 519-809
    • Chonnam National University
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 11 0-744
    • Seoul National University Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham Hospital, Division of Infectious Diseases
  • California
    • La Jolla, California, United States, 92093
      • UC San Diego Moores Cancer Center
    • Sacramento, California, United States, 95817
      • UC Davis Health, Dept. of Internal Medicine, Div. of Infectious Diseases
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Care Health Services, Department of Medicine
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Medical College of Georgia at Augusta University
  • Michigan
    • Detroit, Michigan, United States, 48201
      • DMC Harper University Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota, Department of Medicine
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine, Division of Infectious Disease
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center, Department of Internal Medicine
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Research Center (FHCRC)
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VL-2397; Investigational agent VL-2397 600 mg IV infusion administered every day for 28 days (4 weeks) followed by 2 weeks of standard treatment	Drug: Investigational Agent: VL-2397; VL-2397; Drug: Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B; Voriconazole, Isavuconazole, or Liposomal amphotericin B
Active Comparator: Standard (First-Line) Treatment; Investigator selected standard treatments of voriconazole, isavuconazole, or liposomal amphotericin B administered every day for 42 days (6 weeks) per product package insert	Drug: Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B; Voriconazole, Isavuconazole, or Liposomal amphotericin B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All-cause mortality (ACM)	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACM		6 weeks
Number of participants with adverse events	Number of participants with adverse events	6 weeks

Collaborators and Investigators

• Sponsor: Vical
• Investigators: Study Director: Mammen P Mammen, MD, FIDSA, Vical

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2018
• Primary Completion (Actual): January 14, 2019
• Study Completion (Actual): January 14, 2019

Study Registration Dates

• First Submitted: October 27, 2017
• First Submitted That Met QC Criteria: October 30, 2017
• First Posted (Actual): October 31, 2017

Study Record Updates

• Last Update Posted (Actual): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: IA
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections and Mycoses; Mycoses; Invasive Fungal Infections; Lung Diseases, Fungal; Aspergillosis; Pulmonary Aspergillosis; Invasive Pulmonary Aspergillosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Amebicides; 14-alpha Demethylase Inhibitors; Isavuconazole; Amphotericin B; Liposomal amphotericin B; Voriconazole; VL-2397
• Other Study ID Numbers: VL2397-201; 2017-003435-11 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No