CompletedPhase 3

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

United States, Canada, Puerto Rico517 participantsStarted 2011-04-04

Plain-language 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.

Who can participate

Age range

3 Months – 30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 myelomonocyti…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants With Proven or Probable Invasive Fungal Infections (IFI)

Timeframe: Up to 5 months since enrollment

Trial details

NCT IDNCT01307579

SponsorChildren's Oncology Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2018-06-30

Results submitted2019-06-11

View on ClinicalTrials.gov More Acute Myeloid Leukemia trials