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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03327727
Recruitment Status : Terminated (Business decision)
First Posted : October 31, 2017
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Vical

Tracking Information
First Submitted Date  ICMJE October 27, 2017
First Posted Date  ICMJE October 31, 2017
Last Update Posted Date February 27, 2019
Actual Study Start Date  ICMJE February 20, 2018
Actual Primary Completion Date January 14, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2017)
All-cause mortality (ACM) [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2017)
  • ACM [ Time Frame: 6 weeks ]
  • Number of participants with adverse events [ Time Frame: 6 weeks ]
    Number of participants with adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE VL-2397 Compared to Standard First-Line Treatment for Invasive Aspergillosis (IA) in Adults
Official Title  ICMJE 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
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Invasive Aspergillosis
  • Invasive Pulmonary Aspergillosis
Intervention  ICMJE
  • Drug: Investigational Agent: VL-2397
    VL-2397
  • Drug: Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B
    Voriconazole, Isavuconazole, or Liposomal amphotericin B
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Investigational Agent: VL-2397
    • Drug: Standard treatment: 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
    Intervention: Drug: Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 25, 2019)
4
Original Estimated Enrollment  ICMJE
 (submitted: October 30, 2017)
200
Actual Study Completion Date  ICMJE January 14, 2019
Actual Primary Completion Date January 14, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   France,   Germany,   Korea, Republic of,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03327727
Other Study ID Numbers  ICMJE VL2397-201
2017-003435-11 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Vical
Study Sponsor  ICMJE Vical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mammen P Mammen, MD, FIDSA Vical
PRS Account Vical
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP