Clinical trial · Interventional
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
NCT03327727CI-TRIAL-00037317terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business decision
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Invasive Aspergillosis | — | UNRESOLVED | — |
| Invasive Pulmonary Aspergillosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Investigational Agent: VL-2397 | Drug | — | UNRESOLVED |
| Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- VL-2397
- description
- Investigational agent VL-2397 600 mg IV infusion administered every day for 28 days (4 weeks) followed by 2 weeks of standard treatment
- interventionNames
- Drug: Investigational Agent: VL-2397
- Drug: Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B
- type
- ACTIVE_COMPARATOR
- label
- Standard (First-Line) Treatment
- description
- Investigator selected standard treatments of voriconazole, isavuconazole, or liposomal amphotericin B administered every day for 42 days (6 weeks) per product package insert
- interventionNames
- Drug: Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.