Clinical trial · Interventional
Liposomal Amphotericin B (Ambisome) Versus Oral Voriconazole for the Prevention of Invasive Fungal Infections
Open, Randomized Comparative Trial of Two Different Schedules of Liposomal Amphotericin B Versus Oral Voriconazole for the Prevention of Invasive Fungal Infections
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical research study is to compare the effectiveness of liposomal amphotericin B given three times per week , versus liposomal amphotericin B given once per week, versus oral voriconazole in the prevention of fungal infections in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes MDS who are receiving chemotherapy. The safety of these treatments will also be studied and compared.
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 |
|---|---|---|---|
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liposomal amphotericin B | Drug | — | UNRESOLVED |
| Voriconazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Liposomal amphotericin B: 3 mg/kg
- description
- 3 mg/kg intravenously (IV) three times per week
- interventionNames
- Drug: Liposomal amphotericin B
- type
- EXPERIMENTAL
- label
- Liposomal amphotericin B: 9 mg/kg
- description
- 9 mg/kg IV once per week
- interventionNames
- Drug: Liposomal amphotericin B
- type
- EXPERIMENTAL
- label
- Voriconazole: 400 mg
- description
- 400 mg oral twice daily day 1 followed by 200 mg twice daily
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of AML or high risk MDS undergoing induction chemotherapy or first salvage chemotherapy. * Age \>/=18 years. * Patients must sign an informed consent. Exclusion Criteria: * Patients with history of anaphylaxis attributed to azole or amphotericin B compounds. * Patients with clinical or other evidence that indicates that they have proven or probable invasive fungal infection prior to enrollment. * Patients with total bilirubin levels \> 3 times the upper normal limits (i.e. \> 3.0 mg/dl); or serum glutamic pyruvic transaminase (SGPT)\> 5 times upper limit normal. * Patients with serum creatinine \> 2.0 mg/dl. * Patients receiving any medication that is contraindicated with the use of voriconazole. * Patients who have participated in this study during induction chemotherapy.
References
Publications (0)
Data not yet available