AflacLL1901 (CHOA-AML)
Acute Myeloid Leukemia, AML, Childhood
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring acute myeloid leukemia
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
Sites / Locations
- Egleston Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Aflac-AML Regimen for Low Risk AML Patients
Aflac-AML Regimen for High Risk AML Patients
Participants in this arm will receive the standard Aflac-AML Regimen with the following chemotherapy: Induction-1: patients on Induction-I will receive gemtuzumab + ADE therapy based on genotyping. Lasts a total of 28 days. Induction II - MA Intensification I - AE Intensification II - HD ARAC/LASP Patients with low risk status who had low risk markers and were MRD positive at the end of Induction I and continue to be MRD positive after Induction II will come off protocol.
Participants in this arm will receive standard Aflac-AML Regimen with the following chemotherapy: Induction-1: patients will receive gemtuzumab in addition to ADE therapy based on genotyping. Induction I lasts a total of 28 days. Induction 1 for FLT3-ITD patients - ADE (10+3+5) with GO with Sorafenib Induction II - MA Induction II for FLT3-ITD patients - MA with Sorafenib Intensification I - AE Intensification I for FLT3-ITD patients - AE with sorafenib Intensification II - HD ARAC/LASP Intensification II for FLT3-ITD patients - HD ARAC/LASP with sorafenib Hematopoietic stem cell transplantation (HSCT) If a patient is classified as High risk after Induction I, they may proceed to best allogenic donor SCT following Induction II. These patients may receive a third course of chemotherapy prior to HSCT. In cases where HSCT is not an option, patients can receive 4 cycles of chemotherapy. Only patients with FLT3-ITD mutation will receive sorafenib.