Liposomal Amphotericin B (Ambisome) Versus Oral Voriconazole for the Prevention of Invasive Fungal Infections
Open, Randomized Comparative Trial of Two Different Schedules of Liposomal Amphotericin B Versus Oral Voriconazole for the Prevention of Invasive Fungal Infections
1 other identifier
interventional
120
1 country
1
Brief Summary
The goal of this clinical research study is to compare the effectiveness of liposomal amphotericin B given three times per week , versus liposomal amphotericin B given once per week, versus oral voriconazole in the prevention of fungal infections in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes MDS who are receiving chemotherapy. The safety of these treatments will also be studied and compared.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2006
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 3, 2007
CompletedFirst Posted
Study publicly available on registry
January 5, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
May 13, 2011
CompletedAugust 7, 2012
August 1, 2012
2.9 years
January 3, 2007
April 15, 2011
August 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Invasive Fungal Infection
Endpoint was whether participant had an invasive fungal infection or not, a potentially fatal complication with leukemia patients. Efficacy defined as absence of proven and probable fungal infection. Probable fungal infection is: 1) Positive radiographic findings consistent with fungal infections documented on CT imaging: Lower respiratory tract infection: halo sign, air crescent-sign, or cavity within areas of consolidation; Sinus: erosion of sinus walls or extension of infection to neighboring structures, extensive skull base destruction; and/or 2) Two positive galactomannan index test.
35 days from the start of therapy for induction participants and 42 days for salvage participants.
Study Arms (3)
Liposomal amphotericin B: 3 mg/kg
EXPERIMENTAL3 mg/kg intravenously (IV) three times per week
Liposomal amphotericin B: 9 mg/kg
EXPERIMENTAL9 mg/kg IV once per week
Voriconazole: 400 mg
EXPERIMENTAL400 mg oral twice daily day 1 followed by 200 mg twice daily
Interventions
400 mg by mouth twice daily on day 1, followed by 200 mg by mouth twice daily
3 mg/kg intravenously three times per week over 2 hours +/- 15 minutes
Eligibility Criteria
You may qualify if:
- Diagnosis of AML or high risk MDS undergoing induction chemotherapy or first salvage chemotherapy.
- Age \>/=18 years.
- Patients must sign an informed consent.
You may not qualify if:
- Patients with history of anaphylaxis attributed to azole or amphotericin B compounds.
- Patients with clinical or other evidence that indicates that they have proven or probable invasive fungal infection prior to enrollment.
- Patients with total bilirubin levels \> 3 times the upper normal limits (i.e. \> 3.0 mg/dl); or serum glutamic pyruvic transaminase (SGPT)\> 5 times upper limit normal.
- Patients with serum creatinine \> 2.0 mg/dl.
- Patients receiving any medication that is contraindicated with the use of voriconazole.
- Patients who have participated in this study during induction chemotherapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jorge Cortes, MD / Professor
- Organization
- The University of Texas MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Gloria N Mattiuzzi, MD
M.D. Anderson Cancer Center
- STUDY DIRECTOR
Gloria N Mattiuzzi, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2007
First Posted
January 5, 2007
Study Start
November 1, 2006
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
August 7, 2012
Results First Posted
May 13, 2011
Record last verified: 2012-08