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 aplastic phase following induction or consolidation chemotherapy for acute leukaemia, and during the initial phase of allogeneic stem-cell transplant, which are both high risk periods as far as severe fungal infections 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 aplastic phase following induction or consolidation chemotherapy for acute leukaemia, and during the initial phase of allogeneic stem-cell transplant, which are both high risk periods as far as severe fungal infections development is concerned.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
30
Gilead Sciences
Paris, France
The primary endpoint will be the safety defined by the incidence of adverse events occurring during the course of prophylaxis treatment (4 weeks for AL patients and 8 weeks for SCT patients).
The secondary endpoints for assessing efficacy will be the following:
Incidence of probable or proven invasive fungal infection according to EORTC-MSG 35 criteria within the12 weeks following the initiation of prophylaxis treatment.
Incidence of fever of unknown origin requiring empirical antifungal treatment within 12 weeks after trial initiation.
Incidence of superficial fungal infections within 3 months after trial initiation.
Time differential for commencement of empirical antifungal treatment measured within 3 months after trial initiation.
Evidence of colonisation by fungal organisms observed within 3 months after trial initiation.
Survival rate at the end of treatment and incidence of mortality related to fungal infection within 12 weeks and 24 weeks after study drug initiation.
Renal toxicity
The incidence and grade of nephrotoxicity will be assessed.
Hepatotoxicity
The incidence and grade hepatotoxicity will be assessed.
Patients whose AST or ALT becomes > 10 times the ULN will be withdrawn from the study.
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Ionic analysis
Hypokalaemia: its incidence and grade will be evaluated. Potassium supplements received by the patient will be recorded in the Case Report Form.
Hypomagnesaemia: its incidence and grade will be evaluated as well.
Laboratories used by both sites will provide a list of their reference ranges.
Ionic disorders should be corrected throughout the trial.
Cardiovascular toxicity
The most commonly reported cardiovascular adverse events are rhythm disorders. There is a risk of seeing their incidence increase if the infusion is given too quickly.
Vital signs and ECG will be monitored throughout the trial.
Patients will be withdrawn from the trial, if in the investigator's opinion, further participation may put them at risk.
General safety
All adverse events occurring during the trial will be reported in the CRFs.