Acute Myeloid Leukemia Clinical Trial
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | October 2014 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Australia | Box Hill Hospital, Eastern Health | Melbourne | Victoria |
Australia | The Alfred Hosptial | Melbourne | Victoria |
Lead Sponsor | Collaborator |
---|---|
Bayside Health | Gilead Sciences |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety as defined by the incidence of all adverse events occurring by the completion of each trial prophylaxis course. | |||
Secondary | Safety: | |||
Secondary | Incidence of renal toxicity | |||
Secondary | Incidence of hepatotoxicity | |||
Secondary | Incidence of ionic abnormalitities | |||
Secondary | Incidence of cardiovascular toxicity | |||
Secondary | Efficacy: | |||
Secondary | Incidence of proven or probable IFI | |||
Secondary | Incidence of superficial fungal infections | |||
Secondary | Incidence of fever of unknown origin requiring empirical antifungal therapy during any course of prophylaxis | |||
Secondary | Incidence of IFI-related mortality |
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