Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00451711




Registration number
NCT00451711
Ethics application status
Date submitted
21/03/2007
Date registered
23/03/2007
Date last updated
16/12/2013

Titles & IDs
Public title
Intermittent Liposomal Amphotericin B Primary Prophylaxis
Scientific 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
Secondary ID [1] 0 0
IN-AU-131-0176
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Liposomal amphotericin B

Treatment: Drugs: Liposomal amphotericin B
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety as defined by the incidence of all adverse events occurring by the completion of each trial prophylaxis course.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Safety:
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Incidence of renal toxicity
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Incidence of hepatotoxicity
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Incidence of ionic abnormalitities
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Incidence of cardiovascular toxicity
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Efficacy:
Timepoint [6] 0 0
Secondary outcome [7] 0 0
Incidence of proven or probable IFI
Timepoint [7] 0 0
Secondary outcome [8] 0 0
Incidence of superficial fungal infections
Timepoint [8] 0 0
Secondary outcome [9] 0 0
Incidence of fever of unknown origin requiring empirical antifungal therapy during any course of prophylaxis
Timepoint [9] 0 0
Secondary outcome [10] 0 0
Incidence of IFI-related mortality
Timepoint [10] 0 0

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2014
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hosptial - Melbourne
Recruitment hospital [2] 0 0
Box Hill Hospital, Eastern Health - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment postcode(s) [2] 0 0
3129 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Gilead Sciences
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00451711
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
C. Orla Morrissey, MB, BCh, FRACP
Address 0 0
The Alfred Hospital, Level 2 Burnet Institute, Commercial Rd., Melbourne, 3004, Victoria, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
C. Orla Morrissey, MB, BCh, FRACP
Address 0 0
Country 0 0
Phone 0 0
+61 3 9076 2000
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00451711