VL-2397 Compared to Standard First-Line Treatment for Invasive Aspergillosis (IA) in Adults
Purpose
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.
Conditions
- Invasive Aspergillosis
- Invasive Pulmonary Aspergillosis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
- Masking Description
- The Sponsor, safety monitoring board, and data review committee are masked.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
|
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 |
|
More Details
- Status
- Terminated
- Sponsor
- Vical
Study Contact
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).