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 - Prophessor

• Conditions: Fungal Infection High risk patients undergoing allogeneic stem-cell transplantation.; MedDRA version: 14.1Level: HLGTClassification code 10017528Term: Fungal infectious disordersSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2004-003745-40-IT
• Lead Sponsor: GILEAD SCIENCES S.R.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06-28
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.  Male or female patients aged more than 18;  Patients with hematological malignancies undergoing allogeneic stem cell transplantation from donors other than HLA identical sibling; source of stem cell includes either peripheral blood or bone marrow;  No evidence of fungal infection at chest CT scan and at sinus X-ray 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 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;  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 infusion.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion Criteria Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.  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;  Febrile patients (> 38.5°C), excluding the cases of fever due to specific procedures connected with BMT (e.g.: antilynphocytic serum);  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.

Study & Design

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