PROPHESSOR: AmBisome in Antifungal Primary Prophylaxis Treatment of High Risk Patients Undergoing Allogeneic Stem Cell Transplantation

Phase II Pilot Study on Safety of Administration of 3mg/kg/Day Three Times a Week Until Day 22 (21 Days After Transplantation Day) and 7 mg/kg Weekly From Day 29 to the End of Treatment (Day 50-8th Week) of AmBisome® in Antifungal Primary Prophylaxis Treatment of High Risk Patients Undergoing Allogeneic Stem-cell Transplantation

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 initial phase of allogeneic stem-cell transplant and in case of occurrence of graft versus host disease (GvHD), which are both high risk periods as far as severe fungal infection development is concerned.

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 initial phase of allogeneic stem-cell transplant and in case of occurrence of GvHD, which are both high risk periods as far as severe fungal infection development is concerned.

Inclusion Criteria:

• Male or female patients aged more than 18 years
• Patients with hematological malignancies undergoing allogeneic stem cell transplantation from donors other than human leukocyte antigen (HLA) identical sibling; source of stem cell includes either peripheral blood or bone marrow
• No evidence of fungal infection at chest computed tomography (CT) scan and at sinus X-ray at baseline
• Patients with no sign or symptoms of fungal infection and no previous proven or probable invasive fungal infection (IFI)
• Females of childbearing potential must be surgically incapable of pregnancy, or practising a method of birth control, or agree to abstain from heterosexual intercourse while participating in the study, and with a negative pregnancy test (blood or urine) at baseline
• An 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 the hospital, under strict medical supervision). All patients will be hospitalised prior to, and remain in the hospital for at least one day, after the first infusion.

Exclusion Criteria:

• Known hypersensitivity to amphotericin B, in particular known history of anaphylactic reaction to amphotericin B
• Patients undergoing cord transplantation
• Creatinine > 2.0 mg/dL
• 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
• 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 hematological diseases described at the second point of 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.