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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
34
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
Gilead Sciences
Milan, Italy
Safety and tolerability profile will be obtained by considering: Number (%) of patients with adverse events (AEs)
Time frame: Through 16 weeks
Number (%) of patients with infusion related AE
Time frame: Through 16 weeks
Laboratory parameters (in particular renal toxicity, hepatotoxicity, hypokalaemia, hypomagnesaemia)
Time frame: Through 16 weeks
Overall adverse events
Time frame: Through 16 weeks
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
Time frame: 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
Time frame: Within previous 6 months
Number (%) of patients with superficial fungal infections within the 6 months following the initiation of prophylaxis treatment
Time frame: 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
Time frame: Within previous 6 months
Reasons for early study discontinuation
Time frame: Through 16 weeks
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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
Time frame: Within 12 months
Time to probable or proven invasive fungal infection; fever of unknown origin requiring empirical antifungal treatment
Time frame: Through 16 weeks
Time to superficial fungal infections
Time frame: Through 16 weeks
Time to initiation of empirical antifungal treatment
Time frame: Through 16 weeks
Time to study discontinuation
Time frame: Through 16 weeks
Number of patients enrolled
Time frame: Through 16 weeks
Number of patients completing the study
Time frame: Through 16 weeks
Number of patients with early discontinuation
Time frame: Through 16 weeks
Number of patients classified by reason for discontinuing study drug (including the study completion)
Time frame: Through 16 weeks