Alert icon

To align with industry best practices for security and data integrity, Project Data Sphere is requiring users to upgrade their browsers to one that supports encryption protocol TLS 1.2 by December 15, 2017. On that date, Project Data Sphere will disable support of browsers that permit SSL 3.0/TLS 1.0. To prevent any disruption to your access to Project Data Sphere, you must take action.
This browser was not recognized and may not be compatible with TLS 1.2 or higher. Please check with the browser's developer to confirm.
To view information about this, please visit the FAQ. If you have any further questions, please contact us.

Back to the List
Type(s) of Cancer
Leukemia/Lymphoma
Study Phase
Phase 3
Study Completion Date
2018-06-30
NCT01307579Uploaded 03-26-2021
Access via NCI by Request
PDS UID: nci-data-462
A Randomized Open-Label Trial of Caspofungin Versus Fluconazole to Prevent Invasive Fungal Infections in Children Undergoing Chemotherapy for Acute Myeloid Leukemia (AML)
Provider Information
Provider Data DescriptionThere are four data submissions associated with PMID 31688884: NCT01307579-D1 through -D4. This dataset, NCT01307579-D1, provides the information for the consort diagram (Figure 1). Data provided on all enrolled patients (N=517). There is one row per patient.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis 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.
ConditionsAcute 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
Intervention TypeDrug: Caspofungin Acetate
Drug: Fluconazole
Other: Laboratory Biomarker Analysis
Drug(s)Drug: Caspofungin Acetate
Drug: Fluconazole
Total Enrolled517
RandomizationRandomized
Blinding MethodNone
Arms InterventionArm I (caspofungin acetate) - Experimental
Arm II (fluconazole) - Active Comparator
Secondary IDNCI-2011-02640
PubMed (PMID)31688884
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Canada
Puerto Rico
Age Range3 Months to 30 Years (CHILD, ADULT)
Files: NCT01307579-D1
Data DictionaryNCT01307579-D1-Data-Dictionary_1.pdf
DATANCT01307579-D1-Dataset.csv
OTHERREADME.pdf
Files: NCT01307579-D2
Data DictionaryNCT01307579-D2-Data-Dictionary_1.pdf
DATANCT01307579-D2-Dataset.csv
OTHERREADME.pdf
Files: NCT01307579-D3
Data DictionaryNCT01307579-D3-Data-Dictionary_1.pdf
DATANCT01307579-D3-Dataset.csv
OTHERREADME.pdf
Files: NCT01307579-D4
Data DictionaryNCT01307579-D4-Data-Dictionary_1.pdf
DATANCT01307579-D4-Dataset.csv
OTHERREADME.pdf
© 2024 Project Data Sphere
All rights reserved
Privacy PolicyTerms of Use