Nebulized Amphotericin B Lipid Complex in Invasive Pulmonary Aspergillosis in Paediatric Patients With Acute Leukaemia
The aim of this clinical trial is to assess 25-30 patients of both sexes, between the ages of 3 to 18 years, who are receiving intensive chemotherapy treatment for acute myeloblastic or lymphoblastic leukemia (AML, ALL) and will be treated with aerosolised (inhalation) amphotericin B lipid complex (Abelcet®) as a prophylactic for invasive pulmonary aspergillosis during prolonged neutropenia.
The trial will evaluate the overall tolerability of the drug and the efficacy of aerosolised ABLC for primary prophylaxis of invasive pulmonary aspergillosis (IPA). In the event that the working hypothesis is confirmed, aerosolised ABLC treatment would be an effective, safe and reliable prophylactic option for IPA. It would offer an alternative to the systemic administration of antifungal triazoles without affecting the antileukemic treatment in pediatric patients with AL.
Invasive Pulmonary Aspergillosis
Drug: AMPHOTERICIN B
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II CT to Evaluate the Safety and Tolerability of Nebulised Amphotericin B Lipid Complex (ABELCET®) in the Prophylaxis of Invasive Pulmonary Aspergillosis During Prolonged Neutropenia in Paediatric Patients With Acute Leukaemia.|
- Number of Participants with Adverse Events that results in the interruption of treatment, as a Measure of Safety and Tolerability [ Time Frame: Baseline (week 1) and Last week of treatment (the number of the last week is variable by each patient, depending of the number of cicles needed by each patient) ] [ Designated as safety issue: Yes ]The primary efficacy variable will be the proportion of patients who discontinue prophylactic treatment with Abelcet® due to an adverse event that is related or not to the study drug or for intolerability to it. The last week of treatment will have a different calendar for each participant, depending on the number of cicles needed by each patient (it has been anticipated up to 5 cicles of 2-6 weeks each).
- Efficacy of primary prophylaxis with nebulized Abelcet® on the incidence of invasive pulmonary aspergillosis (IPA) in paediatric patients with Acute Leukaemia (AL) undergoing intensive chemotherapy [ Time Frame: Baseline (week 1) to end of profilaxis treatment phase (after 4-5 cycles=each cycle will have 2-6 weeks of duration) ] [ Designated as safety issue: No ]Will be assessed by: a) Proportion of discontinued drug administrations due to a treatment related adverse event or intolerability to treatment (number of discontinued administrations/ number of administrations started; b) Total number of IPA cases; c) Incidence of IPA during the Abelcet® prophylactic treatment period (number of patients with IPA/number of patients on prophylaxis); d) IPA incidence rate during the ABLC prophylactic treatment period.
- Invasive Pulmonary Aspergillosis (IPA)-related mortality during primary prophylaxis with Abelcet® in paediatric patients with (AL) undergoing intensive chemotherapy. [ Time Frame: Baseline (week 1) to end of profilaxis treatment phase (after 4-5 cycles=each cycle will have 2-6 weeks of duration) ] [ Designated as safety issue: Yes ]It will be assessed by: a) Mortality due to IPA; b)Percentage of deaths during the prophylactic treatment period and cause of death.
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||January 2014|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Experimental: Amphotericin B (ABELCET®)
Patients fulfilling inclusion criteria and those giving the general informed consent for the study will initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).
Drug: AMPHOTERICIN B
The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization will be 10 ml (50 mg) twice a week for the first week, and then from the second week onwards it will be 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count is greater than or equal to 1500 cells/mm3.
Other Name: Abelcet® 5 mg/ml
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01615809
|Hospital Sant Joan de Déu|
|Esplugues de Llobregat, Barcelona, Spain, 08950|
|Principal Investigator:||Jesus Estella, PhMD||Hospital Sant Joan de Deu|