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A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations

Comparing standard chemo to new treatments for newly diagnosed AML.

Recruiting
21 years and younger
All
Phase 3
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study is about treating a type of blood cancer called acute myeloid leukemia (AML). Researchers want to see if two new treatments, CPX-351 and gilteritinib, work better than the standard chemotherapy. AML is a cancer that makes too many white blood cells called blasts. Some people with AML have a gene change called FLT3 mutation, which helps cancer cells grow.

CPX-351 contains two drugs, daunorubicin and cytarabine, in a special form that stays in the body longer and may cause fewer heart problems. Gilteritinib is a medicine that can stop the FLT3 gene from making cancer cells grow. This study will compare how well these treatments work and look at their effects, good or bad, including on the heart.

  • The study includes children and young adults under 22 with newly diagnosed AML.
  • Participants will receive different treatments based on their specific cancer type.
  • Regular visits and tests are needed to monitor the treatment effects and heart health.
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Study details
    Acute Myeloid Leukemia

NCT04293562

Children's Oncology Group

12 July 2025

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