Fungal Infection High risk patients undergoing allogeneic stem-cell transplantation. MedDRA version: 14.1 Level: HLGT Classification code 10017528 Term: Fungal infectious disorders System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: AMBISOME*INFUS 10FL LIOF 50MG
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Amphotericin B
CAS Number: 1397-89-3
Concentration unit: mg milligram(s)
Concentrat
Sponsors
GILEAD SCIENCES S.R.L.
Eligibility
Sex/Gender
All
Inclusion criteria
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: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Safety and tolerability profile will be assessed by considering:  Number (%) of patients with Infusion related AEs,  Number (%) of patients with nephrotoxicity (expressed as Serum creatinine > 2 x baseline value);Main Objective: The primary objective of this study is safety and tolerability profile 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.;Secondary Objective: Number(%)of patients with probable or proven invasive fungal infection according to EORTC-MSG criteria11 within the 6 months following the initiation of prophylaxis treatment.Number(%)of patients with fever of unknown origin requiring empirical antifungal treatment within the 6 months following the initiation of prophylaxis treatment.Number(%)of patients with superficial fungal infections within the 6 months following the initiation of prophylaxis treatment.Number(%)of patients with evidence of colonization by fungal organisms observed within the 6 months following initiation of prophylaxis treatment.Reasons for early study discontinuation.Survival rate & incidence of mortality related to fungal infection at end of treatment & within 3,6 & 12 months after the initiation of prophylaxis treatment.Time to following events may also be considered:-probable or proven invasive fungal infection-fever of unknown origin requiring emp | — |
Countries
Italy
Outcome results
None listed