CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 355 enrolled
Drug / intervention
Liposomal amphotericin B +1 moredrug
Likely dose
Liposomal amphotericin B 5 mg/kgfrom 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/NCT01259713
NCT01259713Phase 3Completed
CompareCT.gov

A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Study to Assess the Efficacy, Safety and Tolerability of Prophylactic Liposomal Amphotericin B (AmBisome®) for the Prevention of Invasive Fungal Infections (IFIs) in Subjects Receiving Remission-Induction Chemotherapy for Acute Lymphoblastic Leukemia (ALL)

Gilead Sciences·interventional·Posted Dec 14, 2010·Updated May 7, 2015

In Brief

A Phase 3 clinical trial evaluating Liposomal amphotericin B and Placebo for Invasive Fungal Disease. Completed, enrolled 355 participants across 1 site.

Detailed Summary

The study aims to investigate whether prophylaxis with liposomal amphotericin B (AmBisome®) can reduce the incidence of invasive fungal infections (IFIs) in patients with Acute Lymphoblastic Leukemia (ALL) who are undergoing their first remission induction.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInvasive Fungal Disease
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 14, 2010
Enrollment StartApr 1, 2011
Primary CompletionDec 1, 2013
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 15.5 years ago

Interventions

Liposomal amphotericin Bdrug

Ambisome 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week during induction chemotherapy

Placebodrug

Placebo to match liposomal amphotericin B administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy