About this trial
This study looks at how well standard chemotherapy works compared to two newer treatments, CPX-351 and gilteritinib, for patients with newly diagnosed acute myeloid leukemia (AML). Some patients have a gene change called FLT3 that can affect how their cancer grows. The goal is to see which treatment helps patients more and to learn about any heart effects during treatment.
The trial's ID number is NCT04293562. It is a Phase 3 study, which means it is testing how well the treatments work and their safety. It is FDA-regulated and hopes to include about 1,186 participants.
Who can join
This trial is open to patients under 22 years old who have recently been diagnosed with AML. Patients must meet certain health criteria and cannot have other serious health issues. The trial team will confirm if someone is eligible to join.
Condition
Acute Myeloid Leukemia
The study team makes the final call on eligibility.
What happens in the study
Participants will be randomly assigned to different treatment groups. Some will receive standard chemotherapy, while others will get CPX-351 and/or gilteritinib along with standard care. Everyone will receive careful monitoring and follow-up during the study.
Where
This trial is running at 185 locations in the United States. 169 of them are currently recruiting.
AdventHealth Orlando
Orlando, Florida
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois
Advocate Children's Hospital-Park Ridge
Park Ridge, Illinois
Albany Medical Center
Albany, New York
Alfred I duPont Hospital for Children
Wilmington, Delaware
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada
Arkansas Children's Hospital
Little Rock, Arkansas
Arnold Palmer Hospital for Children
Orlando, Florida
The first 8 of 185 sites are listed here. The registry record has the full list.