Liposomal Amphotericin B (Ambisome) Versus Oral Voriconazole for the Prevention of Invasive Fungal Infections

Completed · Phase 2

Conditions studied: Acute Myelogenous Leukemia, Myelodysplastic Syndrome

In brief

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.

Key facts

Study ID

NCT00418951

Run by

M.D. Anderson Cancer Center

People needed

120

Starts

2006-11-01

Expected to finish

2009-10-01

Last updated by the study team

2012-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of AML or high risk MDS undergoing induction chemotherapy or first salvage chemotherapy.
• Age >/=18 years.
• Patients must sign an informed consent.

You may not qualify if…

• 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.

Where it is running

• The University of Texas M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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