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Pilot Study on Safety of a Weekly Administration of 10mg/kg of AmBisome® in Antifungal Prophylaxis Treatment of Allogeneic Stem-Cell Transplantation and Acute Leukaemia

Phase 4
18 Years
Not Enrolling

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Trial Information

Pilot Study on Safety of a Weekly Administration of 10mg/kg of AmBisome® in Antifungal Prophylaxis Treatment of Allogeneic Stem-Cell Transplantation and Acute Leukaemia

This pilot study was designed in order to evaluate the safety and efficacy of an AmBisome
loading dose regimen, in a weekly administration schedule, during the aplastic phase
following induction or consolidation chemotherapy for acute leukaemia, and during the
initial phase of allogeneic stem-cell transplant, which are both high risk periods as far as
severe fungal infections development is concerned.

Inclusion Criteria:

Male or female patients aged more than 18, Patients undergoing standard myelo-ablative,
conditioning regimen and AGVHD ciclosporin prophylaxis for allogeneic stem cell
transplantation, or Patients with acute leukaemia undergoing first induction therapy or
second induction therapy after relapse, or consolidation therapy, Expected neutropenia <
0.5 giga/l for at least 2 weeks, Normal chest CT scan and/or normal X-ray of the chest at
baseline, Patients with no sign or symptoms of fungal infection and no previous proven or
probable IFI, Females of childbearing potential must be surgically incapable of pregnancy,
or practising an acceptable method of birth control with a negative pregnancy test (blood
or urine) at baseline, Understanding of the study and agreement of the patient to give
written informed consent, Ability and agreement to comply with all study requirements,
Patient willing to attend hospital appointments for each injection (infusions will be
performed in hospital, under strict medical supervision). All patients will be
hospitalised prior to, and remain in hospital for at least one day, after the first

Exclusion Criteria:

Known hypersensitivity to amphotericin B, in particular known history of anaphylactic
reaction to amphotericin B, Patients undergoing cord transplantation, Creatinine clearance
< 60 ml/min, Patient with moderate or severe liver disease as defined by AST or ALT > 5
times the upper limit of normal (ULN), Patients who are unlikely to survive more than 1
month, Febrile patients ( 38.5°C), Patients who have received systemic antifungal therapy
within 15 days prior to the inclusion, Any severe cardiovascular disease (such as
arrhythmias, in particular) which may constitute a contra-indication to AmBisome®
administration, Any severe disease other than the haematological diseases described in the
second inclusion criteria, which in the investigator's judgement may interfere with study
evaluations or affect the patient's safety, Pregnant or nursing females, Patients
previously included in this study, Patients who have taken any investigational drug in the
last 30 days prior to the inclusion.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

The primary endpoint will be the safety defined by the incidence of adverse events occurring during the course of prophylaxis treatment (4 weeks for AL patients and 8 weeks for SCT patients).

Principal Investigator

Lamine Mahi, MD

Investigator Role:

Study Director

Investigator Affiliation:

Gilead Sciences


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

October 2003

Completion Date:

March 2006

Related Keywords:

  • Leukemia
  • antifungal prophylaxis
  • allogeneic stem-cell transplantation
  • acute leukaemia
  • antifungal prophylaxis treatment of allogeneic stem-cell transplantation and acute leukaemia
  • Leukemia
  • Acute Disease