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) - AmbiGUARD

• Conditions: Invasive fungal infections (IFI) in subjects with Acute Lymphoblastic Leukemia (ALL) undergoing remission induction chemotherapy; MedDRA version: 12.1Level: LLTClassification code 10017533Term: Fungal infection

• Registration Number: EUCTR2010-019562-91-PT
• Lead Sponsor: Gilead Sciences International Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-16
• Last Update Posted: 16 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 354

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
•Newly diagnosed ALL receiving an ALL chemotherapy regimen that typically induces at least 10 days of neutropenia
•Age = 18 years
•Able to have all screening tests performed quickly to ensure results can be obtained and evaluated before randomization so that the first dose of randomized study drug for IFI prophylaxis can be administered within 5 days of first remission-induction chemotherapy
•Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
•Known hypersensitivity to amphotericin B or AmBisome, the metabolites or formulation excipients, in particular known history of anaphylactic reaction to amphotericin B or AmBisome or any of its metabolites or formulation excipients.
•Known hypersensitivity to the excipients of the placebo formulation
•Current fever (=38°C) unless explained by noninfectious causes
•Subjects with proven, probable or possible IFI (according to EORTC/MSG criteria) at screening or in subject history
•Pulmonary infiltrates
•Concomitant or previous treatment with an antifungal drug within the previous 30 days unless the plasma level is below the limit of detection or at least 5 half-lives of the antifungal has elapsed since the treatment was given
•Serum creatinine > 2 x the upper limit of the normal range (ULN)
•Grade 3 Liver function test results: alanine aminotransferase or aspartate aminotransferase > 5 x ULN; total bilirubin > 2.5 x ULN
•Any severe co morbidity other than underlying hematological disease (ALL), which in the investigator’s judgment may interfere with study evaluations or affect the subject’s safety.
•Subjects who have taken any investigational drug in the last 30 days prior to screening, with the exception of ALL chemotherapy investigational products being used as part of the subject’s current ALL treatment protocol.
•Pregnant or nursing females.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • To determine the prophylactic efficacy of AmBisome compared to placebo in preventing IFIs in subjects with ALL undergoing remission-induction chemotherapy.;Secondary Objective: • To determine the safety and tolerability of prophylactic AmBisome in subjects with ALL undergoing remission-induction chemotherapy.<br>• To determine the impact of IFI prevention on the efficacy of remission-induction<br>chemotherapy in subjects with ALL.;Primary end point(s): The primary objective of this study is to assess antifungal prophylaxis efficacy of AmBisome 5 mg/kg compared to placebo. <br>The primary efficacy endpoint in support of this objective is the proportion of subjects with proven or probable IFIs during remission-induction<br>chemotherapy for ALL.