CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 120 enrolled
Drug / intervention
Voriconazole +2 moredrug
Likely dose
Voriconazole 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00418951
NCT00418951Phase 2Completed
CompareCT.gov

Open, Randomized Comparative Trial of Two Different Schedules of Liposomal Amphotericin B Versus Oral Voriconazole for the Prevention of Invasive Fungal Infections

M.D. Anderson Cancer Center·interventional·Posted Jan 5, 2007·Updated Aug 7, 2012

In Brief

A Phase 2 clinical trial evaluating Voriconazole and Liposomal amphotericin B for Acute Myelogenous Leukemia and Myelodysplastic Syndrome. Completed, enrolled 120 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myelogenous Leukemia, Myelodysplastic Syndrome
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 5, 2007
Enrollment StartNov 1, 2006
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 19.5 years ago

Interventions

Voriconazoledrug

400 mg by mouth twice daily on day 1, followed by 200 mg by mouth twice daily

Liposomal amphotericin Bdrug

3 mg/kg intravenously three times per week over 2 hours +/- 15 minutes

Liposomal amphotericin Bdrug

9 mg/kg intravenously once per week over 2 hours +/- 15 minutes