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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)


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Invasive Fungal Infection

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Trial Information

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)


Inclusion Criteria:



- Newly diagnosed ALL receiving an ALL chemotherapy regimen that typically induces at
least 10 days of neutropenia

- Age equal or greater than 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

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

proportion of subjects with proven or probable invasive fungal infections

Outcome Description:

Proportion of subjects diagnosed with proven or probable IFIs during remission induction chemotherapy for ALL. Diagnoses of proven or probable IFIs will be assessed according to EORTC/MSG criteria by an independent data review board (IDRB) who will be blinded to subject treatment assignment.

Outcome Time Frame:

during remission induction chemotherapy for ALL (up to 12 weeks)

Safety Issue:

No

Principal Investigator

Mike Hawkins, MD

Investigator Role:

Study Director

Investigator Affiliation:

Gilead Sciences

Authority:

Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Study ID:

GS-EU-131-0247

NCT ID:

NCT01259713

Start Date:

February 2011

Completion Date:

October 2013

Related Keywords:

  • Invasive Fungal Infection
  • Ambisome
  • ALL
  • invasive fungal infection
  • prophylaxis
  • liposomal amphotericin B
  • Invasive fungal infection prophylaxis
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Mycoses

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