AflacLL1901 (CHOA-AML)
Condition: Acute Myeloid Leukemia; AML, Childhood
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Cytarabine; Daunorubicin; Erwinase; Etoposide; Gemtuzumab ozogamicin; Stem cell transplantation (SCT); Sorafenib
Intervention description: 100 mg/m²/dose every 12 hours IV Days 1-10; 50 mg/m²/dose IV Days 1, 3, 5; 25,000 International Units/m²/dose IM Days 2, 9; 150 mg/m²/dose IV Days 1-5; Administered as a single 3 mg/m2 dose of GO to be given between days 6-10 during Induction I for patients with CC genotype, in addition to ADE therapy.; Transplantation of multipotent hematopoietic stem cells from bone marrow; 200 mg/m2/dose daily, rounded to accommodate tablet size. The maximum dose will be 400 mg. Days 7 through 34.
Intervention MeSH terms: Cytarabine; Etoposide; Daunorubicin; Sorafenib; Asparaginase; Gemtuzumab; Calicheamicins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Maximum age: 21 Years
Healthy volunteers: No
Keywords: acute myeloid leukemia

Summary:

      The investigators propose to study an Aflac-AML chemotherapy backbone prospectively to
      validate its use in all pediatric AML and to further evaluate the cardiotoxicity with this
      approach for low risk AML.
    

Eligibility criteria:

        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