Invasive AspergillosisPhase 2NCT03327727
VL-2397 Compared to Standard First-Line Treatment for Invasive Aspergillosis (IA) in Adults
A Phase 2 study testing Investigational Agent: VL-2397 and Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B in people with Invasive Aspergillosis and Invasive Pulmonary Aspergillosis, run by Vical at 28 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Aspergillosis, Invasive Pulmonary Aspergillosis
- What is being tested?
- Investigational Agent: VL-2397 and Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 28 sitesin 6 countries
- Study dates
- 20 Feb 2018to 14 Jan 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute Leukemia (AML or ALL) patient or allo-HCT recipient with a diagnosis of IA
Who cannot join
- Pregnant or breastfeeding
- IA involving sites other than lungs and sinuses
- Graft failure, acute or extensive chronic GvHD
- Uncontrolled diabetes
Trial locations and contacts
28 sites in 6 countries.
28 sites in 6 countries
United States11 sites
Medical College of Georgia at Augusta University
Augusta, Georgia, 30912
University of Alabama at Birmingham Hospital, Division of Infectious Diseases
Birmingham, Alabama, 35233
DMC Harper University Hospital
Detroit, Michigan, 48201
The University of Texas Health Science Center, Department of Internal Medicine
Houston, Texas, 77030
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota, Department of Medicine
Minneapolis, Minnesota, 55455
Christiana Care Health Services, Department of Medicine
Newark, Delaware, 19718
UC Davis Health, Dept. of Internal Medicine, Div. of Infectious Diseases
Sacramento, California, 95817
Fred Hutchinson Cancer Research Center (FHCRC)
Seattle, Washington, 98109
Washington University School of Medicine, Division of Infectious Disease
St Louis, Missouri, 63110
Belgium5 sites
General Hospital Saint-Jan, Department of Hematology
Bruges, 8000
Jules Bordet Institute, Department of Infectious Disease
Brussels, 1000
University Hospital Antwerp (UZA), Department of Hematology
Edegem, Antwerp, B-2650
University Hospitals Leuven, Campus Gasthuisberg, Department of Hematology
Leuven, 3000
UCL Mont-Godinne University Hospitals, Department of Hematology
Yvoir, B-5530
South Korea4 sites
Chonnam National University
Hwasun, 519-809
Samsung Medical Center
Seoul, 06351
Seoul National University Hospital
Seoul, 11 0-744
Asan Medical Center
Seoul, 138-736
Canada3 sites
Hamilton Health Sciences, Infectious Disease Research
Hamilton, Ontario, L8V 1C3
McGill University Health Centre (MUHC), Division of Infectios Diseases
Montreal, Quebec, H4A 3J1
Toronto General Hospital
Toronto, Ontario, M5G 2N2
France3 sites
Grenoble University Hospital Center, Department of Hematology
Grenoble, 38700
South Lyon Hospital Center
Pierre-Bénite, 69310
Hautepierre Hospital
Strasbourg, 67200
Germany2 sites
University Hospital Jena
Jena, 07740
Hospital Neuperlach - Municipal Hospital Munich GmbH, Clinic of Hematology and Oncology
Munich, 81737
About this study
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
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.
Read the 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).
- Being tested
- Investigational Agent: VL-2397, Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B
- Keywords
- IA
- Medical subject headings
- Invasive Pulmonary Aspergillosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Agent: VL-2397Drug
VL-2397
Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin BDrug
Voriconazole, Isavuconazole, or Liposomal amphotericin B
| Study group | Role | What they receive |
|---|---|---|
| VL-2397 | Experimental | Investigational agent VL-2397 600 mg IV infusion administered every day for 28 days (4 weeks) followed by 2 weeks of standard treatment Receives: Drug: Investigational Agent: VL-2397; Drug: Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B |
| Standard (First-Line) Treatment | Active comparator | Investigator selected standard treatments of voriconazole, isavuconazole, or liposomal amphotericin B administered every day for 42 days (6 weeks) per product package insert Receives: Drug: Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality (ACM)
Measured: 4 weeks
Secondary outcomes (2)
ACM
Measured: 6 weeks
Number of participants with adverse events
Number of participants with adverse events
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start20 Feb 2018
- Primary completion14 Jan 2019
- Study completion14 Jan 2019
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive AspergillosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mammen P Mammen, MD, FIDSA, Study director, Vical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327727
- Sponsor's protocol ID
- VL2397-201
- Other IDs
- 2017-003435-11, 2017
- Status last verified
- Feb 2019
- First submitted
- 27 Oct 2017
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03327727
- Acronym / sponsor ID
- VL2397-201
- Keywords
- IA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 4 participants (actual)
- Lead sponsor
- VicalIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 14 Jan 2019 (actual)
- Study completion
- 14 Jan 2019 (actual)
- First posted
- 31 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VL-2397 | Experimental | Drug: Investigational Agent: VL-2397, Drug: Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin BInvestigational 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 comparator | Drug: Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin BInvestigator selected standard treatments of voriconazole, isavuconazole, or liposomal amphotericin B administered every day for 42 days (6 weeks) per product package insert |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Acute Leukemia (AML or ALL) patient or allo-HCT recipient with a diagnosis of IA
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding
- IA involving sites other than lungs and sinuses
- Graft failure, acute or extensive chronic GvHD
- Uncontrolled diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational Agent: VL-2397VL-2397 | Drug | VL-2397 |
| Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin BVoriconazole, Isavuconazole, or Liposomal amphotericin B | Drug | Standard (First-Line) Treatment, VL-2397 |
Primary outcome
All-cause mortality (ACM)
Time frame: 4 weeks
2 secondary outcomes
ACM
Time frame: 6 weeks
Number of participants with adverse events
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mammen P Mammen, MD, FIDSA study director
Vical
28 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Investigational Agent: VL-2397 and Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B in people with Invasive Aspergillosis and Invasive Pulmonary Aspergillosis, run by Vical at 28 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Belgium, South Korea, Canada, France and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (ACM) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.