Clinical trial · Interventional
Intermittent Liposomal Amphotericin B Primary Prophylaxis
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
NCT00451711CI-TRIAL-00012993unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liposomal amphotericin B | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Safety as defined by the incidence of all adverse events occurring by the completion of each trial prophylaxis course.
Secondary outcomes (10)
- measure
- Safety:
- measure
- Incidence of renal toxicity
- measure
- Incidence of hepatotoxicity
- measure
- Incidence of ionic abnormalitities
- measure
- Incidence of cardiovascular toxicity
- measure
- Efficacy:
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.