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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03327727

Enrollment

Registered

2017-10-31

Start date

2018-02-20

Completion date

2019-01-14

Last updated

2019-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive Aspergillosis, Invasive Pulmonary Aspergillosis

Keywords

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).

Interventions

DRUGInvestigational Agent: VL-2397

VL-2397

DRUGStandard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B

Voriconazole, Isavuconazole, or Liposomal amphotericin B

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Masking description

The Sponsor, safety monitoring board, and data review committee are masked.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
All-cause mortality (ACM)	4 weeks

Secondary

Measure	Time frame	Description
ACM	6 weeks	—
Number of participants with adverse events	6 weeks	Number of participants with adverse events

Countries

Belgium, Canada, France, Germany, South Korea, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026