CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 517 enrolled
Drug / intervention
Caspofungin Acetate +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01307579
NCT01307579Phase 3Completed
CompareCT.gov

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

Children's Oncology Group·interventional·Posted Mar 3, 2011·Updated Mar 30, 2021

In Brief

A Phase 3 clinical trial evaluating Caspofungin Acetate, Fluconazole, and 1 other intervention for Acute Myeloid Leukemia and 27 related conditions. Completed, enrolled 517 participants across 179 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
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
CountriesCanada, Puerto Rico, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 3, 2011
Enrollment StartApr 4, 2011
Primary CompletionJun 30, 2018
Study CompletionJun 30, 2020
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 15.3 years ago

Interventions

Caspofungin Acetatedrug

Given IV

Fluconazoledrug

Given IV or PO

Laboratory Biomarker Analysisother

Correlative studies