AflacLL1901 (CHOA-AML)

Inclusion Criteria:

* Age: Patients must be less than 21 years of age at the time of study enrollment
* Diagnosis: Patients must be newly diagnosed with AML
* Patients with previously untreated primary AML who meet the customary criteria for AML with ≥ 20% bone marrow blasts as set out in the 2016 WHO Myeloid Neoplasm Classification are eligible.
* Attempts to obtain bone marrow either by aspirate or biopsy must be made unless clinically prohibitive. In cases where it is clinically prohibitive, peripheral blood with an excess of 20% blasts and in which adequate flow cytometric and cytogenetics/FISH testing is feasible can be substituted for the marrow exam at diagnosis.
* Patients with \<20% bone marrow blasts are eligible if they have:

  * A karyotypic abnormality characteristic of de novo AML (t(8;21)(q22;q22), inv(16)(p13q22) or t(16;16)(p13;q22) or 11q23 abnormalities,
  * the unequivocal presence of megakaryoblasts, or
  * Biopsy proven isolated myeloid sarcoma (myeloblastoma; chloroma, including leukemia cutis)
* Performance Level: Patients with acceptable organ function and any performance status are eligible for enrollment

Exclusion Criteria:

* Patients with any of the following constitutional conditions are not eligible:

  * Fanconi anemia
  * Shwachman syndrome
  * Any other known bone marrow failure syndrome
  * Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21 Note: Enrollment may occur, pending results of clinically indicated studies to exclude these conditions.
* Other Excluded Conditions:

  * Any concurrent malignancy
  * Juvenile myelomonocytic leukemia (JMML)
  * Philadelphia chromosome positive AML
  * Biphenotypic or bilineal acute leukemia
  * Acute promyelocytic leukemia (APL)
  * Acute myeloid leukemia arising from myelodysplasia
  * Therapy-related myeloid neoplasms