Acute Myeloid LeukemiaPhase 2NCT00451711
Intermittent Liposomal Amphotericin B Primary Prophylaxis
A Phase 2 study testing Liposomal amphotericin B in people with Acute Myeloid Leukemia, run by Bayside Health at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Liposomal amphotericin B
- How many people
- 60 participants
- Where
- 2 sitesAustralia
- Study dates
- May 2007to Oct 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
2 sites in 1 country.
Anthony P Schwarer, MB, BS, FRACP, MD, FRCPA contact
Australia2 sites, 2 recruiting
- Not yet recruiting
The Alfred Hosptial
Melbourne, Victoria, 3004
C. Orla Morrissey, MB, BCh, FRACP
Anthony P Schwarer, MB, BS, FRACP, MD, FRCPA
- Recruiting
Box Hill Hospital, Eastern Health
Melbourne, Victoria, 3129
Anthony P Schwarer, MB, BS, FRACP, MD, FRCPA, +61 3 9895 3333, anthony.schwarer@boxhill.org.au
Anthony P. Schwarer, MB, BS, FRACP, MD, FRCPA
About this study
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
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.
Read the 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.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Liposomal amphotericin B
- Keywords
- Prophylaxis, Liposomal Amphotericin B, Acute myeloid leukaemia, Invasive Fungal Infections
- Medical subject headings
- Leukemia, Myeloid, Acute, Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal amphotericin BDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as defined by the incidence of all adverse events occurring by the completion of each trial prophylaxis course.
Secondary outcomes (10)
Safety:
Incidence of renal toxicity
Incidence of hepatotoxicity
Incidence of ionic abnormalitities
Incidence of cardiovascular toxicity
Efficacy:
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2007 (estimated)
- Study startMay 2007
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- C. Orla Morrissey, MB, BCh, FRACP, Principal investigator, The Alfred Hospital, Level 2 Burnet Institute, Commercial Rd., Melbourne, 3004, Victoria, AustraliaAnthony P Schwarer, MB, BS, FRACP, MD, FRCPA, Principal investigator, The Alfred Hospital, Ground Floor South Block, Commercial Rd., Melbourne, Victoria, 3004, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451711
- Sponsor's protocol ID
- IN-AU-131-0176
- Status last verified
- Mar 2007
- First submitted
- 21 Mar 2007
- Last updated
- 16 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00451711
- Acronym / sponsor ID
- IN-AU-131-0176
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Prophylaxis, Liposomal Amphotericin B, Acute myeloid leukaemia, Invasive Fungal Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bayside HealthOther government
- Collaborators
- Gilead Sciences
- Study start
- May 2007
- Study completion
- Oct 2014 (estimated)
- First posted
- 23 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal amphotericin B | Drug | – |
Primary outcome
Safety as defined by the incidence of all adverse events occurring by the completion of each trial prophylaxis course.
10 secondary outcomes
Safety:
Incidence of renal toxicity
Incidence of hepatotoxicity
Incidence of ionic abnormalitities
Incidence of cardiovascular toxicity
Efficacy:
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony P Schwarer, MB, BS, FRACP, MD, FRCPA contact
C. Orla Morrissey, MB, BCh, FRACP principal investigator
The Alfred Hospital, Level 2 Burnet Institute, Commercial Rd., Melbourne, 3004, Victoria, Australia
Anthony P Schwarer, MB, BS, FRACP, MD, FRCPA principal investigator
The Alfred Hospital, Ground Floor South Block, Commercial Rd., Melbourne, Victoria, 3004, Australia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liposomal amphotericin B in people with Acute Myeloid Leukemia, run by Bayside Health at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact C. Orla Morrissey, MB, BCh, FRACP (+61 3 9076 2000 ext. 62631, o.morrissey@alfred.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as defined by the incidence of all adverse events occurring by the completion of each trial prophylaxis course.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2013.