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

Completed · Phase 3

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT01307579

Run by

Children's Oncology Group

People needed

517

Starts

2011-04-04

Expected to finish

2020-06-30

Last updated by the study team

2021-03-30

Who can join

Age: 0 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
• Phoenix Childrens Hospital — Phoenix, Arizona, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Kaiser Permanente Downey Medical Center — Downey, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Miller Children's and Women's Hospital Long Beach — Long Beach, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Valley Children's Hospital — Madera, California, United States
• Kaiser Permanente-Oakland — Oakland, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
• Rady Children's Hospital - San Diego — San Diego, California, United States
• UCSF Medical Center-Parnassus — San Francisco, California, United States
• UCSF Medical Center-Mission Bay — San Francisco, California, United States
• Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center — Torrance, California, United States
• Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center — Denver, Colorado, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Broward Health Medical Center — Fort Lauderdale, Florida, United States
• Children's Hospital of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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