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Trial Title:
Intermittent Liposomal Amphotericin B Primary Prophylaxis
NCT ID:
NCT00451711
Condition:
Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Amphotericin B
Liposomal amphotericin B
Conditions: Keywords:
Prophylaxis
Liposomal Amphotericin B
Acute myeloid leukaemia
Invasive Fungal Infections
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Liposomal amphotericin B
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 (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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Patients fulfilling all the following criteria will be eligible:
- Male or female aged >18years;
- Newly diagnosed with acute myeloid leukaemia and undergoing first induction
chemotherapy regimen;
- Expected to have absolute neutrophil counts of <0.5x109/L for at least 2 weeks;
- Normal high resolution chest and sinus CT scan at baseline;
- No signs or symptoms of invasive fungal infections
- No prior diagnosis of proven or probable invasive fungal infection within the last 6
months;
- Females of childbearing potential must be: surgically incapable of pregnancy; or
practicing an acceptable mode of birth control and have a negative pregnancy test
(blood or urine) at baseline;
- Give written informed consent prior to any study-specific procedures;
- Must have the ability and must agree to comply with all study requirements.
Exclusion Criteria:
Patients with any of the following will be ineligible
- Known hypersensitivity to amphotericin B, in particular known history of
anaphylactic reaction to amphotericin B;
- Patients undergoing any transplantation;
- Creatinine clearance <60mL/min/1.72 m2;
- Patients with moderate or severe liver disease as defined by aspartate
aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times the upper limit
of normal (ULN)
- Patients who are unlikely to survive more than one month;
- Patients who have received systemic antifungal therapy within the last 15 days
- Any severe cardiovascular disease ( in particular arrhythmias) which may constitute
a contra-indication to LAB (AmBisome®) administration;
- Any severe diseases other than acute myeloid leukaemia which in the investigator's
judgement may interfere with study evaluations or affect the patients safety;
- Pregnant or nursing females;
- Patients previously included in this study;
- Patients who have taken an investigational drug in the last 30 days prior to the
inclusion.
- Patients enrolled in a pre-emptive treatment strategy trial
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Alfred Hosptial
Address:
City:
Melbourne
Zip:
3004
Country:
Australia
Status:
Not yet recruiting
Investigator:
Last name:
C. Orla Morrissey, MB, BCh, FRACP
Email:
Principal Investigator
Investigator:
Last name:
Anthony P Schwarer, MB, BS, FRACP, MD, FRCPA
Email:
Principal Investigator
Investigator:
Last name:
Sushrat Patil, MB, BS, FRACP, FRCPA
Email:
Sub-Investigator
Facility:
Name:
Box Hill Hospital, Eastern Health
Address:
City:
Melbourne
Zip:
3129
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Anthony P Schwarer, MB, BS, FRACP, MD, FRCPA
Phone:
+61 3 9895 3333
Email:
anthony.schwarer@boxhill.org.au
Investigator:
Last name:
Anthony P. Schwarer, MB, BS, FRACP, MD, FRCPA
Email:
Principal Investigator
Start date:
May 2007
Completion date:
October 2014
Lead sponsor:
Agency:
Bayside Health
Agency class:
Other
Collaborator:
Agency:
Gilead Sciences
Agency class:
Industry
Source:
Bayside Health
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00451711