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

Vical

Status and phase: Terminated; Phase 2

Conditions: Invasive Aspergillosis; Invasive Pulmonary Aspergillosis

Treatments: Drug: Investigational Agent: VL-2397; Drug: Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B

Study type: Interventional

Funder types: Industry

Identifiers

NCT03327727

2017-003435-11 (EudraCT Number)

VL2397-201

Details and patient eligibility

About

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.

Full 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).

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4 participants in 2 patient groups

VL-2397

Experimental group

Description:

Investigational agent VL-2397 600 mg IV infusion administered every day for 28 days (4 weeks) followed by 2 weeks of standard treatment

Treatment:

Drug: Investigational Agent: VL-2397

Drug: Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B

Standard (First-Line) Treatment

Active Comparator group

Description:

Investigator selected standard treatments of voriconazole, isavuconazole, or liposomal amphotericin B administered every day for 42 days (6 weeks) per product package insert

Treatment:

Drug: Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B