Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00451711
Status:
UNKNOWN
Last Update Posted:
2013-12-16
First Post:
2007-03-21
Brief Title:
Intermittent Liposomal Amphotericin B Primary Prophylaxis
Sponsor:
Bayside Health
Organization:
Bayside Health
Study Overview
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 10mgkg of AmBisome in Antifungal Primary Prophylaxis of High-Risk Patients With Acute Myeloid Leukaemia
Status:
UNKNOWN
Status Verified Date:
2007-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this trial is to see which dose of liposomal amphotericin B is the safest when used as a preventer against invasive fungal infection in patients with acute leukaemia who are undergoing chemotherapy
Detailed Description:
Invasive Fungal Infections IFIare 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 BLAB 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 ie 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 ie 3mgkg three times a week or 10mgkg 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 1mgkg daily of LAB
Males and females aged 18 years who are undergoing intensive combination chemotherapy for acute leukaemia will be randomised 111 to either 1mgkg daily 3mgkg 3 times a week or 10mgkg once weekly of intravenous liposomal amphotericin B The 3 arms will be compared for the safety of the 3 dosing regimens
Liposomal amphotericin BLAB 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 ie 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 ie 3mgkg three times a week or 10mgkg 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 1mgkg daily of LAB
Males and females aged 18 years who are undergoing intensive combination chemotherapy for acute leukaemia will be randomised 111 to either 1mgkg daily 3mgkg 3 times a week or 10mgkg once weekly of intravenous liposomal amphotericin B The 3 arms will be compared for the safety of the 3 dosing regimens
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None