Caspofungin Versus Fluconazole in Preventing Invasive Fungal Infections (IFI) in Patients Undergoing Chemotherapy for Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia; Adult Acute Monoblastic Leukemia; Adult Acute Monocytic Leukemia; Adult Acute Myeloid Leukemia in Remission; Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With Maturation; Adult Acute Myeloid Leukemia With Minimal Differentiation; Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1; Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A; Adult Acute Myeloid Leukemia Without Maturation; Adult Acute Myelomonocytic Leukemia; Alkylating Agent-Related Acute Myeloid Leukemia; Childhood Acute Monoblastic Leukemia; Childhood Acute Monocytic Leukemia; Childhood Acute Myeloid Leukemia in Remission; Childhood Acute Myeloid Leukemia With Maturation; Childhood Acute Myeloid Leukemia With Minimal Differentiation; Childhood Acute Myeloid Leukemia Without Maturation; Childhood Acute Myelomonocytic Leukemia; Fungal Infection; Myeloid Neoplasm; Neutropenia; Recurrent Adult Acute Myeloid Leukemia; Recurrent Childhood Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia; Untreated Childhood Myeloid Neoplasm
MeSH terms: Infections; Communicable Diseases; Mycoses; Invasive Fungal Infections; Leukemia; Neoplasms; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Leukemia, Myelomonocytic, Acute; Leukemia, Myelomonocytic, Chronic; Leukemia, Monocytic, Acute; Neutropenia; Recurrence
Intervention: Caspofungin Acetate; Fluconazole; Laboratory Biomarker Analysis
Intervention description: Given IV; Given IV or PO; Correlative studies
Intervention MeSH terms: Fluconazole; Caspofungin
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 517.0
Sex: All
Minimum age: 3 Months
Maximum age: 30 Years
Healthy volunteers: No
Keywords: Pediatrics; leukemia; invasive fungal infection

Summary:

      This randomized phase III trial compares the effectiveness of caspofungin to fluconazole in
      preventing invasive fungal infections in patients receiving chemotherapy for acute myeloid
      leukemia (AML). Antifungal prophylaxis is considered standard of care in children and adults
      with prolonged neutropenia after chemotherapy for AML however the ideal antifungal agent for
      prophylaxis in children is not known. Caspofungin has activity against yeast and some molds
      while fluconazole coverage is limited to just yeasts. Adult randomized trials suggest that
      agents with activity against yeasts and molds are more effective than those with just
      activity against yeasts. There are limited data to answer this comparative question in
      children. This study will establish much needed pediatric data to guide clinical decision
      making on optimal antifungal prophylaxis.
    

Eligibility criteria:

        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 AND 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