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Study details
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A Study Comparing Chemotherapy to CPX-351 and/or Gilteritinib for Acute Myeloid Leukemia

Children's Oncology Group
NCT IDNCT04293562ClinicalTrials.gov data as of Apr 2026
Phase

Phase 3

Target enrollment

1,186

Study length

about 8.9 years

Ages

≤21

Locations

185 sites in AL, AR, AZ +44

What this study is about

Researchers are testing whether a treatment with liposome-encapsulated daunorubicin-cytarabine (CPX-351) and/or gilteritinib, in addition to standard chemotherapy, improves outcomes for people newly diagnosed with acute myeloid leukemia. The trial will compare the effects of this new treatment approach to standard chemotherapy alone.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Fludeoxyglucose F-18
  • 2.Questionnaire Administration
  • 3.Take Asparaginase Erwinia chrysanthemi
  • +3 more

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Injection / IVInjection / IV

How treatment is administered

Treatment Assignment
Randomized (Open Label)

You are randomly assigned, but you will know your treatment.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Drug classes

ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS, cytarabine, Antineoplastic Agent [TC] (DNA Polymerase Inhibitors), Cardiovascular Agent [TC] (Chelating Activity), etoposide, fludeoxyglucose (18F), gemtuzumab ozogamicin, Antineoplastic Agent [TC] (Receptor Tyrosine Kinase Inhibitors)

Drug routes

injection (Injection), infusion, injection, intravenous, oral (Oral Tablet)

Endpoints

Primary: Event-free survival (EFS)

Secondary: Incidence of adverse events, Overall survival (OS)

Procedures

diagnostic, biopsy, imaging

Body systems

Oncology