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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Acute Myeloid Leukemia
  • Age: Between 1 years - 21 years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1) Patient must be newly diagnosed with de novo AML according to the 2016 WHO classification with or without extramedullary disease. 2) All patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to enrollment and treatment on AAML1831.

You may not be eligible for this study if the following are true:

  • 1) Patients with the following constitutional conditions are not eligible: Patients with myeloid neoplasms with germline predisposition are not eligible, Fanconi anemia, Shwachman Diamond syndrome, Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21, and any other known bone marrow failure syndrome. 2) Patients with any of the following oncologic diagnoses are not eligible: any concurrent malignancy, juvenile myelomonocytic leukemia (JMML), Philadelphia chromosome positive AML, Mixed phenotype acute leukemia, Acute promyelocytic leukemia, Acute myeloid leukemia arising from myelodysplasia, and therapy-related myeloid neoplasms.


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