Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

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.

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

Details

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).

Keywords

Invasive Aspergillosis Invasive Pulmonary Aspergillosis IA Aspergillosis Pulmonary Aspergillosis Voriconazole Amphotericin B Liposomal amphotericin B Investigational Agent: VL-2397 Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B

Eligibility

You can join if…

Open to people ages 18 years and up

  • Acute Leukemia (AML or ALL) patient or allo-HCT recipient with a diagnosis of IA

You CAN'T join if...

  • Pregnant or breastfeeding
  • IA involving sites other than lungs and sinuses
  • Graft failure, acute or extensive chronic GvHD
  • Uncontrolled diabetes

Locations

  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • UC Davis Health, Dept. of Internal Medicine, Div. of Infectious Diseases accepting new patients
    Sacramento California 95817 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Vical
ID
NCT03327727
Phase
Phase 2
Study Type
Interventional
Last Updated