Study Stopped
Business decision
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
2 other identifiers
interventional
4
6 countries
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2018
Shorter than P25 for phase_2
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2017
CompletedFirst Posted
Study publicly available on registry
October 31, 2017
CompletedStudy Start
First participant enrolled
February 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 14, 2019
CompletedFebruary 27, 2019
February 1, 2019
11 months
October 27, 2017
February 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All-cause mortality (ACM)
4 weeks
Secondary Outcomes (2)
ACM
6 weeks
Number of participants with adverse events
6 weeks
Study Arms (2)
VL-2397
EXPERIMENTALInvestigational agent VL-2397 600 mg IV infusion administered every day for 28 days (4 weeks) followed by 2 weeks of standard treatment
Standard (First-Line) Treatment
ACTIVE COMPARATORInvestigator selected standard treatments of voriconazole, isavuconazole, or liposomal amphotericin B administered every day for 42 days (6 weeks) per product package insert
Interventions
Voriconazole, Isavuconazole, or Liposomal amphotericin B
Eligibility Criteria
You may qualify if:
- Acute Leukemia (AML or ALL) patient or allo-HCT recipient with a diagnosis of IA
You may not qualify if:
- Pregnant or breastfeeding
- IA involving sites other than lungs and sinuses
- Graft failure, acute or extensive chronic GvHD
- Uncontrolled diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vicallead
Study Sites (28)
University of Alabama at Birmingham Hospital, Division of Infectious Diseases
Birmingham, Alabama, 35233, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
UC Davis Health, Dept. of Internal Medicine, Div. of Infectious Diseases
Sacramento, California, 95817, United States
Christiana Care Health Services, Department of Medicine
Newark, Delaware, 19718, United States
Medical College of Georgia at Augusta University
Augusta, Georgia, 30912, United States
DMC Harper University Hospital
Detroit, Michigan, 48201, United States
University of Minnesota, Department of Medicine
Minneapolis, Minnesota, 55455, United States
Washington University School of Medicine, Division of Infectious Disease
St Louis, Missouri, 63110, United States
The University of Texas Health Science Center, Department of Internal Medicine
Houston, Texas, 77030, United States
Fred Hutchinson Cancer Research Center (FHCRC)
Seattle, Washington, 98109, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
University Hospital Antwerp (UZA), Department of Hematology
Edegem, Antwerp, B-2650, Belgium
General Hospital Saint-Jan, Department of Hematology
Bruges, 8000, Belgium
Jules Bordet Institute, Department of Infectious Disease
Brussels, 1000, Belgium
University Hospitals Leuven, Campus Gasthuisberg, Department of Hematology
Leuven, 3000, Belgium
UCL Mont-Godinne University Hospitals, Department of Hematology
Yvoir, B-5530, Belgium
Hamilton Health Sciences, Infectious Disease Research
Hamilton, Ontario, L8V 1C3, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2N2, Canada
McGill University Health Centre (MUHC), Division of Infectios Diseases
Montreal, Quebec, H4A 3J1, Canada
Grenoble University Hospital Center, Department of Hematology
Grenoble, 38700, France
South Lyon Hospital Center
Pierre-Bénite, 69310, France
Hautepierre Hospital
Strasbourg, 67200, France
University Hospital Jena
Jena, 07740, Germany
Hospital Neuperlach - Municipal Hospital Munich GmbH, Clinic of Hematology and Oncology
Munich, 81737, Germany
Chonnam National University
Hwasun, 519-809, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Seoul National University Hospital
Seoul, 11 0-744, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mammen P Mammen, MD, FIDSA
Vical
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The Sponsor, safety monitoring board, and data review committee are masked.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2017
First Posted
October 31, 2017
Study Start
February 20, 2018
Primary Completion
January 14, 2019
Study Completion
January 14, 2019
Last Updated
February 27, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share