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Clinical Trial COGACCL0933

Title

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

Principal Investigator(s)

Haydar Frangoul

Details

  • Protocol No. COGACCL0933
  • Open Date: 11/16/2011
  • Staging: Phase III
  • Age Group: Both Child and Adult
  • Scope: International
  • Objective: To determine if prophylaxis with caspofungin 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.
  • Disease Sites: Leukemia; Pediatric Leukemia
  • Therapies: None Specified
  • Drugs: Caspofungin; Fluconazole
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01307579
  • Secondary Protocol No: ACCL0933

Description

None Provided.

Eligibility

Ages Eligible for Study:3 Months to 30 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

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
• 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