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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.
Ambisome and voriconazole are drugs that have been used to fight fungal infections, which typically occur during chemotherapy as a result of lowered immune system functioning. Ambisome works by binding to the sterol component of the fungal cell membrane. This causes "holes" to appear in the membrane, which leads to death of the fungal cell. Voriconazole inhibits an essential step of the biosynthesis of an important component of the fungal cell wall (ergosterol). This causes the impairment of the fungal cell wall.
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will be asked questions about your medical history. You will have a complete physical exam and a chest x-ray. You will have computed tomography (CT) scans of the chest. You will also have about 1 teaspoon of blood drawn for routine tests. Test results from the pregnancy test that you will have before your leukemia treatment will be looked at for this study. You will not have a pregnancy test performed for this study.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of dice) to one of 3 treatment groups (Group 1, Group 2, or Group 3). Participants in Groups 1 and 2 will receive treatment with ambisome. Participants in Group 3 will receive treatment with voriconazole. Participants in all 3 groups will begin treatment 24 hours after the last dose of chemotherapy.
If you are assigned to Group 1, you will receive ambisome by vein as a continuous infusion over 2 hours 1 time per day, 3 times each week.
If you are assigned to Group 2, you will receive ambisome by vein as a continuous infusion over 2 hours 1 time per week.
If you are assigned to Group 3, you will take 2 pills by mouth (1 hour after breakfast) and 2 pills by mouth (1 hour after dinner) for 1 day, which amounts to 4 pills in total on Day 1. You will then take 1 pill by mouth (1 hour after breakfast) and 1 pill by mouth (1 hour after dinner) everyday for the remainder of this study, which amounts to 2 pills in total each day.
You will have about 1 teaspoon of blood drawn for routine tests 2 times each week. You will also receive treatment with standard of care medications. These medications (which will be specified by your doctor) will be used to help decrease the risk of developing bacterial infections and viral infections.
If you develop a fever during treatment on this study, you will have a chest x-ray and a CT scan of the chest within 3 days after the fever started.
You may remain on this study for up to 35 days (if you are receiving chemotherapy for the first time) and up to 42 days (if you have had prior chemotherapy). Your participation may end on this study if your study doctor thinks it is necessary, if other antifungal therapy is required, or if you develop any intolerable side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal amphotericin B: 3 mg/kg | Experimental | 3 mg/kg intravenously (IV) three times per week |
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| Liposomal amphotericin B: 9 mg/kg | Experimental | 9 mg/kg IV once per week |
|
| Voriconazole: 400 mg | Experimental | 400 mg oral twice daily day 1 followed by 200 mg twice daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voriconazole | Drug | 400 mg by mouth twice daily on day 1, followed by 200 mg by mouth twice daily |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gloria N Mattiuzzi, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Gloria N Mattiuzzi, MD | M.D. Anderson Cancer Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| M.D. Anderson's website | View source |
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Eight of 120 patients registered never received study drug, therefore were excluded from the study.
Recruitment Period: 11/3/2006 to 8/4/09. All patients registered at The University of Texas M.D. Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Liposomal Amphotericin B: 3 mg/kg | 3 mg/kg intravenously (IV) three times per week |
| FG001 | Liposomal Amphotericin B: 9 mg/kg | 9 mg/kg IV once per week |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Liposomal amphotericin B | Drug | 3 mg/kg intravenously three times per week over 2 hours +/- 15 minutes |
|
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| Liposomal amphotericin B | Drug | 9 mg/kg intravenously once per week over 2 hours +/- 15 minutes |
|
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| FG002 | Voriconazole: 400 mg | 400 mg oral twice daily day 1 followed by 200 mg twice daily |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Liposomal Amphotericin B: 3 mg/kg | 3 mg/kg intravenously (IV) three times per week |
| BG001 | Liposomal Amphotericin B: 9 mg/kg | 9 mg/kg IV once per week |
| BG002 | Voriconazole: 400 mg | 400 mg oral twice daily day 1 followed by 200 mg twice daily |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Outcome evaluability required at least two doses of study drug. | Posted | Number | participants | 35 days from the start of therapy for induction participants and 42 days for salvage participants. |
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Three years, ten months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Liposomal Amphotericin B: 3 mg/kg | 3 mg/kg intravenously (IV) three times per week | 5 | 39 | 0 | 39 | ||
| EG001 | Liposomal Amphotericin B: 9 mg/kg | 9 mg/kg IV once per week | 2 | 33 | 0 | 33 | ||
| EG002 | Voriconazole: 400 mg | 400 mg oral twice daily day 1 followed by 200 mg twice daily | 4 | 40 | 0 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Supravnetricular Tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Death | General disorders | CTCAE (3.0) | Systematic Assessment | unrelated to study drug |
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| Allergic Reaction | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperbilirubinemia | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
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| Acute Renal Failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
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| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection Sepsis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Chest Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Elevated alanine aminotransferase | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jorge Cortes, MD / Professor | The University of Texas MD Anderson Cancer Center | 713-745-5783 | eharrison@mdanderson.org |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
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| ID | Term |
|---|---|
| D065819 | Voriconazole |
| C068538 | liposomal amphotericin B |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
|