Clinical trial NCT00369317 (phase 3, status: unknown status)
Conditions: childhood acute basophilic leukemia, childhood acute eosinophilic leukemia, childhood acute erythroleukemia (m6), childhood acute megakaryocytic leukemia (m7), childhood acute minimally differentiated myeloid leukemia (m0), childhood acute monoblastic leukemia (m5a), childhood acute monocytic leukemia (m5b), childhood acute myeloblastic leukemia with maturation (m2), childhood acute myeloblastic leukemia without maturation (m1), childhood acute myelomonocytic leukemia (m4), childhood myelodysplastic syndromes, de novo myelodysplastic syndromes, secondary acute myeloid leukemia, secondary myelodysplastic syndromes, untreated childhood acute myeloid leukemia and other myeloid malignancies
ICD codes: D46.Z, D46.9, C94.6, D46.C, D75.1, E26.1, N91.1, N91.4, N94.5, A51.41, A51.43, D46.Z, D46.9, C94.6, D46.C
Drugs: asparaginase, daunorubicin hydrochloride, cytarabine, thioguanine, etoposide
SMILES: N[C@@H](CC(O)=O)C(O)=O, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(C)=O)C(O)=C1C2=O, ClCCN(CCCl)P1(=O)NCCCO1, NC1=NC(=S)C2=C(N1)N=CN2, OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis DS or DS mosaicism by karyotype or chromosomal analysis

          -  Diagnosis of myelodysplastic syndromes (MDS) with < 30% blasts or acute myeloid
             leukemia (AML)

               -  Newly diagnosed disease

          -  Patients with a history of transient myeloproliferative disorder (TMD) are eligible
             provided the patient is diagnosed with AML or MDS at > 90 days of age AND meets either
             of the following criteria:

               -  At least 30% blasts in the bone marrow regardless of time since resolution of TMD

               -  More than 8 weeks since resolution of TMD with ≥ 5% blasts in the bone marrow

          -  Immunophenotype required for study entry

          -  No promyelocytic leukemia

          -  Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide
             angiogram

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  AST or ALT < 2.5 times ULN

          -  Creatinine adjusted according to age as follows:

               -  No greater than 0.4 mg/dL (≤ 5 months)

               -  No greater than 0.5 mg/dL (6 months -11 months)

               -  No greater than 0.6 mg/dL (1 year-23 months)

               -  No greater than 0.8 mg/dL (2 years-5 years)

               -  No greater than 1.0 mg/dL (6 years-9 years)

               -  No greater than 1.2 mg/dL (10 years-12 years)

               -  No greater than 1.4 mg/dL (13 years and over [female])

               -  No greater than 1.5 mg/dL (13 years to 15 years [male])

               -  No greater than 1.7 mg/dL (16 years and over [male])

          -  Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

          -  No evidence of dyspnea at rest

          -  No exercise intolerance

          -  Pulse oximetry > 94%

          -  No prior chemotherapy, radiotherapy, or any antileukemic therapy

               -  Intrathecal cytarabine therapy given at diagnosis allowed

          -  Prior therapy for TMD allowed