Intermittent Liposomal Amphotericin B Primary Prophylaxis

• Status: Unknown status
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayside Health
• Collaborator: Gilead Sciences
• Treatments: Amphotericin B; Liposomal amphotericin B

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