Caspofungin Acetate or Fluconazole in Preventing Invasive Fungal Infections in Patients With Acute Myeloid Leukemia Who Are Undergoing Chemotherapy



Status:Completed
Conditions:Blood Cancer, Infectious Disease, Women's Studies, Hematology, Leukemia
Therapuetic Areas:Hematology, Immunology / Infectious Diseases, Oncology, Reproductive
Healthy:No
Age Range:Any - 30
Updated:11/3/2018
Start Date:April 4, 2011
End Date:June 30, 2018

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A Randomized Open-Label Trial of Caspofungin Versus Fluconazole to Prevent Invasive Fungal Infections in Children Undergoing Chemotherapy for Acute Myeloid Leukemia (AML)

This randomized phase III trial studies caspofungin acetate to see how it works compared to
fluconazole in preventing invasive fungal infections in patients with acute myeloid leukemia
who are undergoing chemotherapy. Caspofungin acetate or fluconazole may help prevent fungal
infections caused by chemotherapy. It is not yet known whether fluconazole is more effective
than caspofungin acetate in preventing fungal infections in patients with acute myeloid
leukemia who are undergoing chemotherapy.

PRIMARY OBJECTIVES:

I. To determine if prophylaxis with caspofungin (caspofungin acetate) administered during
periods of neutropenia following chemotherapy for acute myeloid leukemia (AML) is associated
with a lower incidence of proven or probable invasive fungal infections (IFI) compared with
fluconazole.

SECONDARY OBJECTIVES:

I. To determine if prophylaxis with caspofungin will result in a lower incidence of proven or
probable cases of invasive aspergillosis (IA) compared with fluconazole. (Clinical) II. To
determine if prophylaxis with caspofungin will result in improved survival compared to
fluconazole. (Clinical) III. To determine if prophylaxis with caspofungin will result in less
empiric antifungal therapy compared to fluconazole. (Clinical) IV. To determine the
sensitivity, specificity, and positive and negative predictive value of biweekly
galactomannan (GM) and beta-D glucan testing in diagnosing IFI. (Biological) V. To test the
association between single nucleotide polymorphisms (SNPs) in genes involved in innate
immunity and proven or probable IFI. (Biological) VI. To develop predictive models of IFI
using SNP in genes involved in immunity and clinical covariates. (Biological)

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive caspofungin acetate intravenously (IV) over 1 hour once daily (QD)
beginning within 24-72 hours following the last dose of chemotherapy for each course and
continuing until absolute neutrophil count (ANC) > 100-500/uL following the nadir or the next
chemotherapy course begins.

ARM II: Patients receive fluconazole IV over 1-2 hours or orally (PO) QD beginning within
24-72 hours following the last dose of chemotherapy for each course and continuing until ANC
> 100-500/uL following the nadir or the next chemotherapy course begins.

In both arms, treatment continues in the absence of invasive fungal infections or disease
progression.

After completion of study treatment, patients are followed up periodically.

Inclusion Criteria:

- Patients must have one of the following diagnoses and/or treatment plans:

- Newly diagnosed de novo AML

- First or subsequent relapse of AML

- Secondary AML

- Treatment with institutional standard AML therapy in those without AML (for
example, myelodysplastic syndrome, bone marrow blasts > 5% or biphenotypia)

- Note: Patients with a history of prolonged antifungal therapy (example, relapsed
AML) are eligible

- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
mL/min/1.73 m^2 OR a serum creatinine based on age/gender as follows:

- =< 0.4 mg/dL (age 1 month to < 6 months)

- =< 0.5 mg/dL (age 6 months to < 1 year)

- =< 0.6 mg/dL (age 1 to < 2 years)

- =< 0.8 mg/dL (age 2 to < 6 years)

- =< 1 mg/dL (age 6 to < 10 years)

- =< 1.2 mg/dL (age 10 to < 13 years)

- =< 1.4 mg/dL (females age >= 13 years)

- =< 1.5 mg/dL (males age 13 to < 16 years)

- =< 1.7 mg/dL (males age >= 16 years)

- Total bilirubin =< 1.5 x upper limit of normal (ULN) for age

- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or
serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x
ULN for age

- All patients and/or their parents or legal guardians must sign a written informed
consent

Exclusion Criteria:

- Patients with the following diagnoses are not eligible:

- Acute promyelocytic leukemia (APL)

- Down syndrome

- Juvenile myelomonocytic leukemia (JMML)

- Patients with a documented history of invasive fungal infection (IFI) within the
previous 30 days are not eligible

- Patients with a history of echinocandin or fluconazole hypersensitivity are not
eligible

- Patients receiving treatment for an IFI are not eligible

- Female patients of childbearing age must have a negative pregnancy test

- Patients must agree to use an effective birth control method

- Lactating patients must agree not to nurse a child while on this trial
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Principal Investigator: Robert J. Fallon
Phone: 317-274-2552
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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Indianapolis, IN
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Indianapolis, Indiana 46260
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Iowa City, IA
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Jacksonville, Florida 32207
Principal Investigator: Eric S. Sandler
Phone: 904-697-3529
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Jacksonville, FL
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Kalamazoo, Michigan 49008
Principal Investigator: Jeffrey S. Lobel
Phone: 800-227-2345
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Kalamazoo, MI
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Las Vegas, Nevada 89144
Principal Investigator: Jonathan Bernstein
Phone: 702-384-0013
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Las Vegas, NV
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Las Vegas, Nevada 89109
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Las Vegas, NV
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Sara Chaffee
Phone: 800-639-6918
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lebanon, NH
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Lexington, KY
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