Title (COG ACCL0933) 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 Martin Brecher, MD
Study Number 206811
This study will utilize a two-arm, open-label randomized design to evaluate the efficacy of prophylaxis with caspofungin in comparison with fluconazole in children with de novo, relapsed or secondary AML. Study agent will begin following completion of each course of chemotherapy and continue through periods of neutropenia. It will also evaluate the usefulness of the Platelia EIA Aspergillus galactomannan (GM) assay as well as the beta-D glucan testing in early diagnosis of IFI.
- Greater than or equal to 3 months and less than or equal to 30 years of age
- Patients must have one of the following diagnoses: newly diagnosed de novo AML, first or subsequent relapse of AML, or secondary AML
- Adequate renal, and liver function as defined in section 3.2.3
- Patients who have APL, Down Syndrome, or JMML are ineligible
- Patients with a documented history of 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 and lactating patients must agree not to nurse while on this trial.