Risk-Stratified Therapy for Acute Myeloid Leukemia in Down Syndrome

Study ID: Children's Oncology Group (COG) - AAML1531NCT Number: NCT02521493Trial Title: Risk-Stratified Therapy for Acute Myeloid Leukemia in Down SyndromeSubmitted in collaboration with the NCTN/NCORP Data ArchiveData presented in the following publication(s): 34320162 Disease type(s): Hematopoietic Neoplasm/Leukemia - Acute Myeloid Leukemia; Hematopoietic Neoplasm/Leukemia - Myelodysplastic SyndromeDataset(s) included:NCT02521493-D1: There are 2 datasets associated with PMID 34320162, NCT02521493-D1 through NCT02521493-D2. The NCT02521493-D1 dataset is a patient level dataset (single row per patient) containing patient characteristics, laboratory findings, and outcome for eligible myeloid leukemia in children with Down syndrome (ML-DS) enrolled on the AAML1531 clinical trial.NCT02521493-D2: There are 2 datasets associated with PMID 34320162, NCT02521493-D1 through NCT02521493-D2. The NCT02521493-D2 dataset is an adverse event level dataset (single row per adverse event, period, and patient) containing information of the micro-organisms associated with adverse events by period in the AAML1531 clinical trial.]]>
NCT02521493 D1 Data DictionaryNCT02521493 D2 Data DictionaryInclusion Criteria: Patients must have constitutional trisomy 21 (Down syndrome) or trisomy 21 mosaicism (by karyotype or fluorescence in situ hybridization [FISH]). All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human subjects research must be met.Patient has one of the following: Patient has previously untreated de novo AML and meets the criteria for AML with >= 20% bone marrow blasts as set out in the World Health Organization (WHO) Myeloid Neoplasm classification 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 Patient has cytopenias and/or bone marrow blasts but does not meet the criteria for the diagnosis of AML (WHO Myeloid Neoplasm classification), because of < 20% marrow blasts, and meets the criteria for a diagnosis of myelodysplastic syndrome (MDS) For patients who do not meet criteria for AML or MDS as outlined above, patient has a history of transient myeloproliferative disorder (which may or may not have required chemotherapy intervention, and: Is > 8 weeks since resolution of transient myeloproliferative disease (TMD) with >= 5% blasts, OR Has an increasing blast count (>= 5%) in serial bone marrow aspirates performed at least 4 weeks apart Exclusion Criteria:Children who have previously received chemotherapy, radiation therapy or any anti-leukemic therapy are not eligible for this protocol, with the exception of cytarabine for the treatment of TMDPatients with promyelocytic leukemia (French-American-British [FAB] M3) Prior therapy patients <=30 days from the last dose of cytarabine used for treatment of TMDThere are no minimal organ function requirements for enrollment in this study. Note: Previous cardiac repair with sufficient cardiac function is not an exclusion criteria. Each patient's parents or legal guardians must sign a written informed consent. ]]>