AflacLL1901 (CHOA-AML)

• Status: Terminated
• Trial end date: 2021-05-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Treatments: Asparaginase; Calicheamicins; Cytarabine; Daunorubicin; Etoposide; Gemtuzumab; Sorafenib

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