Phase 2 N=112 Randomized Prevention

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

Acute Myelogenous Leukemia · Myelodysplastic Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT00418951 ↗

Enrolled (actual)

112

Serious AEs

9.8%

Results posted

May 2011

Primary outcome: Primary: Number of Participants With Invasive Fungal Infection — 3; 4; 2 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Voriconazole (Drug); Liposomal amphotericin B (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: M.D. Anderson Cancer Center
Primary completion: Oct 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Invasive Fungal Infection	3; 4; 2	—

Summary

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00418951). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.