A Phase III Study Comparing Standard Chemotherapy to Treatment with CPX-351 and/or Gilteritinib for Children Newly Diagnosed with Acute Myeloid Leukemia

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Full Title

A Phase 3 Randomized Trial for Patients with de novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 with GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients with FLT3 Mutations (AAML1831) (CIRB)

Purpose

Daunorubicin, cytarabine, and gemtuzumab ozogamicin are different chemotherapy drugs used to treat acute myeloid leukemia (AML). CPX-351 is made up of daunorubicin and cytarabine. It is created in a way that makes the drugs stay in the bone marrow longer and could be less likely to cause heart problems than traditional anthracycline drugs, a common class of chemotherapy drugs used in cancer care.

Some patients with AML have an abnormality in a gene called FLT3, which plays an important role in the production of blood cells. This gene can have permanent changes that make cancer cells grow. Gilteritinib may block the abnormal function of the FLT3 gene.

In this study, researchers are comparing different treatment regimens in children, adolescents, and young adults newly diagnosed with AML. Patients will be randomly assigned to one of these groups:

  • Standard chemotherapy with or without gilteritinib
  • CPX-351 with or without gilteritinib

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must be newly diagnosed with AML.
  • This study is for patients under age 22.

For more information about this study and to inquire about eligibility, please contact 1-833-MSK-KIDS.

Protocol

20-483

Phase

III

Disease Status

Newly Diagnosed

Investigator