NCT00451711

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 Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2007

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
7.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

December 16, 2013

Status Verified

March 1, 2007

First QC Date

March 21, 2007

Last Update Submit

December 12, 2013

Conditions

Acute Myeloid Leukemia

Keywords

ProphylaxisLiposomal Amphotericin BAcute myeloid leukaemiaInvasive Fungal Infections

Outcome Measures

Primary Outcomes (1)

  • Safety as defined by the incidence of all adverse events occurring by the completion of each trial prophylaxis course.

Secondary Outcomes (10)

  • Safety:

  • Incidence of renal toxicity

  • Incidence of hepatotoxicity

  • Incidence of ionic abnormalitities

  • Incidence of cardiovascular toxicity

  • +5 more secondary outcomes

Interventions

Liposomal amphotericin BDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 enrolled in a pre-emptive treatment strategy trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Alfred Hosptial

Melbourne, Victoria, 3004, Australia

NOT YET RECRUITING

Box Hill Hospital, Eastern Health

Melbourne, Victoria, 3129, Australia

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteInvasive Fungal Infections

Interventions

liposomal amphotericin B

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesMycosesBacterial Infections and MycosesInfections

Study Officials

  • C. Orla Morrissey, MB, BCh, FRACP

    The Alfred Hospital, Level 2 Burnet Institute, Commercial Rd., Melbourne, 3004, Victoria, Australia

    PRINCIPAL INVESTIGATOR

  • Anthony P Schwarer, MB, BS, FRACP, MD, FRCPA

    The Alfred Hospital, Ground Floor South Block, Commercial Rd., Melbourne, Victoria, 3004, Australia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

C. Orla Morrissey, MB, BCh, FRACP

CONTACT

+61 3 9076 2000o.morrissey@alfred.org.au

Anthony P Schwarer, MB, BS, FRACP, MD, FRCPA

CONTACT

+61 3 9076 2000a.schwarer@alfred.org.au

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2007

First Posted

March 23, 2007

Study Start

May 1, 2007

Study Completion

October 1, 2014

Last Updated

December 16, 2013

Record last verified: 2007-03

Locations

AU(2)