AflacLL1901 (CHOA-AML)

Stopped early · Phase 2

Conditions studied: Acute Myeloid Leukemia, AML, Childhood

In brief

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.

Key facts

Study ID

NCT04326439

Run by

Emory University

People needed

8

Starts

2020-01-24

Expected to finish

2022-03-15

Last updated by the study team

2022-06-15

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Egleston Hospital — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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