Intermittent Liposomal Amphotericin B Primary Prophylaxis
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|ClinicalTrials.gov Identifier: NCT00451711|
Recruitment Status : Unknown
Verified March 2007 by Bayside Health.
Recruitment status was: Recruiting
First Posted : March 23, 2007
Last Update Posted : December 16, 2013
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: Liposomal amphotericin B||Phase 2|
Invasive Fungal Infections (IFI)are a significant cause of death in patients with acute leukaemia who are undergoing chemotherapy. This is despite improvements in antifungal therapy for the treatment of IFI. The major reason for this is that the current standard diagnostic tests of culture and biopsy lack the ability to make a diagnosis, either early or accurately. Thus other strategies such as the use of prophylaxis are needed. Several antifungal agents have been trialled as prophylaxis but all have disadvantages that limit their effectiveness.
Liposomal amphotericin B(LAB) is a broad spectrum antifungal agent that kills fungal cells. When given in high doses intermittently it supersaturates the liver and the overspill into the bloodstream is absorbed by tissues such as lung, brain and kidneys (i.e. sites where IFI are likely to occur). This effect has been shown in a number of animal and laboratory test-tube studies to reduce fungal burden, improve survival and maintain adequate levels of the drug in between doses. However no intermittent high-dose prophylaxis study has been done in humans. Thus before we proceed to a randomised controlled clinical trial of the efficacy of intermittent high-dose LAB compared with another antifungal agent it is necessary to determine in a phase 2 study which of 2 intermittent dosing LAB regimens (i.e. 3mg/kg three times a week or 10mg/kg once a week) administered during the neutropenic phase of induction-consolidation chemotherapy for treatment of acute leukaemia is safest and best tolerated compared to the standard dosing regimen of 1mg/kg daily of LAB.
Males and females aged >18 years who are undergoing intensive combination chemotherapy for acute leukaemia will be randomised 1:1:1 to either 1mg/kg daily; 3mg/kg 3 times a week or 10mg/kg once weekly of intravenous liposomal amphotericin B. The 3 arms will be compared for the safety of the 3 dosing regimens.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomised, Stratified, Open Label, Phase II Pilot Study on the Safety of a Daily, Intermittent, or Weekly Administration of 1, 3 or 10mg/kg of AmBisome® in Antifungal Primary Prophylaxis of High-Risk Patients With Acute Myeloid Leukaemia|
|Study Start Date :||May 2007|
|Estimated Study Completion Date :||October 2014|
- Safety as defined by the incidence of all adverse events occurring by the completion of each trial prophylaxis course.
- Incidence of renal toxicity
- Incidence of hepatotoxicity
- Incidence of ionic abnormalitities
- Incidence of cardiovascular toxicity
- Incidence of proven or probable IFI
- Incidence of superficial fungal infections
- Incidence of fever of unknown origin requiring empirical antifungal therapy during any course of prophylaxis
- Incidence of IFI-related mortality
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00451711
|Contact: C. Orla Morrissey, MB, BCh, FRACP||+61 3 9076 2000 ext email@example.com|
|Contact: Anthony P Schwarer, MB, BS, FRACP, MD, FRCPA||+61 3 9076 2000 ext firstname.lastname@example.org|
|The Alfred Hosptial||Not yet recruiting|
|Melbourne, Victoria, Australia, 3004|
|Principal Investigator: C. Orla Morrissey, MB, BCh, FRACP|
|Principal Investigator: Anthony P Schwarer, MB, BS, FRACP, MD, FRCPA|
|Sub-Investigator: Sushrat Patil, MB, BS, FRACP, FRCPA|
|Box Hill Hospital, Eastern Health||Recruiting|
|Melbourne, Victoria, Australia, 3129|
|Contact: Anthony P Schwarer, MB, BS, FRACP, MD, FRCPA +61 3 9895 3333 email@example.com|
|Principal Investigator: Anthony P. Schwarer, MB, BS, FRACP, MD, FRCPA|
|Principal Investigator:||C. Orla Morrissey, MB, BCh, FRACP||The Alfred Hospital, Level 2 Burnet Institute, Commercial Rd., Melbourne, 3004, Victoria, Australia|
|Principal Investigator:||Anthony P Schwarer, MB, BS, FRACP, MD, FRCPA||The Alfred Hospital, Ground Floor South Block, Commercial Rd., Melbourne, Victoria, 3004, Australia|