Caspofungin Versus Fluconazole in Preventing Invasive Fungal Infections (IFI) in Patients Undergoing Chemotherapy for Acute Myeloid Leukemia

• Status: Completed
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Caspofungin; Echinocandins; Fluconazole

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