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

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ClinicalTrials.gov Identifier: NCT03327727
Recruitment Status : Recruiting
First Posted : October 31, 2017
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Invasive Aspergillosis Invasive Pulmonary Aspergillosis Drug: Investigational Agent: VL-2397 Drug: Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B Phase 2

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  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The Sponsor, safety monitoring board, and data review committee are masked.
Primary Purpose: Treatment
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
Actual Study Start Date : February 20, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019


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




Primary Outcome Measures :
  1. All-cause mortality (ACM) [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. ACM [ Time Frame: 6 weeks ]
  2. Number of participants with adverse events [ Time Frame: 6 weeks ]
    Number of participants with adverse events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03327727


Contacts
Contact: VL2397-201 Team 858-646-1100 info@vical.com

Locations
United States, Alabama
University of Alabama at Birmingham Hospital, Division of Infectious Diseases Recruiting
Birmingham, Alabama, United States, 35233
Contact: Melissa D Garner, BSN, RN    205-934-9662    mdgarner@uabmc.edu   
United States, California
UC Davis Health, Dept. of Internal Medicine, Div. of Infectious Diseases Recruiting
Sacramento, California, United States, 95817
Contact: Kate Trigg, MPH, CCRC    916-734-8033    ktrigg@ucdavis.edu   
United States, Delaware
Christiana Care Health Services, Department of Medicine Recruiting
Newark, Delaware, United States, 19718
Contact: Robie A Zent, BSN, RN, CCRC    1-302-733-4164    rzent@christianacare.org   
United States, Georgia
Medical College of Georgia at Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Aprile Osborn, RN    706-721-0309    aosborn@augusta.edu   
United States, Michigan
DMC Harper University Hospital Recruiting
Detroit, Michigan, United States, 48201
Contact: Susmita Jain    313-993-0253    sujain@med.wayne.edu   
United States, Minnesota
University of Minnesota, Department of Medicine Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Casey Dahl, MBS    612-626-3798    dahl0465@umn.edu   
United States, Texas
The University of Texas Health Science Center - Houston Recruiting
Houston, Texas, United States, 77030
Contact: Shelbie Martin    713-500-6761    shelbie.a.martin@uth.tmc.edu   
United States, Washington
Fred Hutchinson Cancer Research Center (FHCRC) Recruiting
Seattle, Washington, United States, 98109
Contact: Cherise Athay       cathay@fredhutch.org   
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Sonija Parker    414-955-0492    smparker@mcw.edu   
Belgium
University Hospital Antwerp (UZA), Department of Hematology Recruiting
Edegem, Antwerp, Belgium, B-2650
Contact: Pascale De Graef    +32 3 821 53 98    studies.hematologie@uza.be   
General Hospital Saint-Jan, Department of Hematology Recruiting
Brugge, Belgium, 8000
Contact: Valerie Tanghe    32 50 453 949    valerie.tanghe@azbrugge.be   
University Hospitals Leuven, Campus Gasthuisberg, Department of Hematology Recruiting
Leuven, Belgium, 3000
Contact: Marlies Mangelschots    +32(0)16 342 040    marlies.mangelschots@uzleuven.be   
Contact: Kathleen Schoofs    +32 16 34 76 82    kathleen.schoofs@uzleuven.be   
Canada, Ontario
Hamilton Health Sciences, Infectious Disease Research Recruiting
Hamilton, Ontario, Canada, L8V 1C3
Contact: Tracy Reed    905-521-2100 ext 42199    reed@hhsc.ca   
Germany
University Hospital Jena Recruiting
Jena, Germany, 07740
Contact: Maria Hertig    +49 (0) 3641 9 396673    maria.hertig@med.uni-jena.de   
Contact: Daniela Hayde    +49 (0) 3641 9 396673    daniela.hayde@med.uni-jena.de   
Sponsors and Collaborators
Vical
Investigators
Study Director: Mammen P Mammen, MD, FIDSA Vical

Responsible Party: Vical
ClinicalTrials.gov Identifier: NCT03327727     History of Changes
Other Study ID Numbers: VL2397-201
2017-003435-11 ( EudraCT Number )
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vical:
IA

Additional relevant MeSH terms:
Aspergillosis
Pulmonary Aspergillosis
Invasive Pulmonary Aspergillosis
Mycoses
Hyalohyphomycosis
Dermatomycoses
Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases
Lung Diseases
Respiratory Tract Diseases
Invasive Fungal Infections
Voriconazole
Amphotericin B
Liposomal amphotericin B
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Bacterial Agents