Status:
UNKNOWN
Intermittent Liposomal Amphotericin B Primary Prophylaxis
Lead Sponsor:
Bayside Health
Collaborating Sponsors:
Gilead Sciences
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00451711
Start Date
May 1 2007
End Date
October 1 2014
Last Update
December 16 2013
Active Locations (2)
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1
The Alfred Hosptial
Melbourne, Victoria, Australia, 3004
2
Box Hill Hospital, Eastern Health
Melbourne, Victoria, Australia, 3129