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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AmBisome® will be administered for a duration of 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AmBisome | Drug | 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®, IV administration |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability profile will be obtained by considering: Number (%) of patients with adverse events (AEs) | Through 16 weeks | |
| Number (%) of patients with infusion related AE | Through 16 weeks | |
| Laboratory parameters (in particular renal toxicity, hepatotoxicity, hypokalaemia, hypomagnesaemia) | Through 16 weeks | |
| Overall adverse events | Through 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number (%) of patients with probable or proven invasive fungal infection according to EORTC-MSG criteria within the 6 months following the initiation of prophylaxis treatment | Within previous 6 months | |
| Number (%) of patients with fever of unknown origin requiring empirical antifungal treatment within the 6 months following the initiation of prophylaxis treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luigi Picaro, MD | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gilead Sciences | Milan | 20146 | Italy |
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| ID | Term |
|---|---|
| D009181 | Mycoses |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C068538 | liposomal amphotericin B |
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| Within previous 6 months |
| Number (%) of patients with superficial fungal infections within the 6 months following the initiation of prophylaxis treatment | Within previous 6 months |
| Number (%) of patients with evidence of colonization by fungal organisms observed within the 6 months following the initiation of prophylaxis treatment | Within previous 6 months |
| Reasons for early study discontinuation | Through 16 weeks |
| Survival rate and incidence of mortality related to fungal infection at the end of treatment and within 3, 6, and 12 months after the initiation of prophylaxis treatment | Within 12 months |
| Time to probable or proven invasive fungal infection; fever of unknown origin requiring empirical antifungal treatment | Through 16 weeks |
| Time to superficial fungal infections | Through 16 weeks |
| Time to initiation of empirical antifungal treatment | Through 16 weeks |
| Time to study discontinuation | Through 16 weeks |
| Number of patients enrolled | Through 16 weeks |
| Number of patients completing the study | Through 16 weeks |
| Number of patients with early discontinuation | Through 16 weeks |
| Number of patients classified by reason for discontinuing study drug (including the study completion) | Through 16 weeks |