Clinical trial NCT00070174 (phase 2, status: completed)
Conditions: leukemia
ICD codes: C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01
Drugs: asparaginase, busulfan, cyclophosphamide, cyclosporine, cytarabine, daunorubicin hydrochloride, etoposide, gemtuzumab ozogamicin, methotrexate, mitoxantrone hydrochloride
SMILES: N[C@@H](CC(O)=O)C(O)=O, CS(=O)(=O)OCCCCOS(C)(=O)=O, ClCCN(CCCl)P1(=O)NCCCO1, CC[C@@H]1NC(=O)[C@H]([C@H](O)[C@H](C)C\C=C\C)N(C)C(=O)[C@H](C(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](NC(=O)[C@H](CC(C)C)N(C)C(=O)CN(C)C1=O)C(C)C, ClCCN(CCCl)P1(=O)NCCCO1, 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, OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1, CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O, OCCNCCNC1=CC=C(NCCNCCO)C2=C1C(=O)C1=C(C(O)=CC=C1O)C2=O
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Newly diagnosed primary acute myeloid leukemia (AML)

               -  At least 20% bone marrow blasts

               -  Meets the customary FAB criteria for AML

                    -  Patients with cytopenias and bone marrow blasts who do not meet the FAB
                       criteria are eligible provided they have a karyotypic abnormality
                       characteristic of de novo AML (e.g., t[8;21], inv16, or t[16;16]) OR they
                       have the unequivocal presence of megakaryoblasts

               -  Isolated granulocytic sarcoma (myeloblastoma) allowed regardless of the results
                  outlined above

          -  Previously untreated disease

          -  No promyelocytic leukemia (FAB M3)

          -  No documented myelodysplastic syndromes (preleukemia) (e.g., chronic myelomonocytic
             leukemia, refractory anemia [RA], RA with excess blasts, or RA with ringed
             sideroblasts)

          -  No juvenile myelomonocytic leukemia

          -  No Fanconi's anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone
             marrow failure syndrome

          -  No Down syndrome

        PATIENT CHARACTERISTICS:

        Age

          -  1 month to 21 years* NOTE: *Children under 1 month of age who have progressive disease
             are allowed

        Performance status

          -  Karnofsky 50-100% (over 16 years of age) OR

          -  Lansky 50-100% (ages 1 to 16)* NOTE: Children under 1 year of age do not require a
             performance status

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Not specified

        Hepatic

          -  No inadequate liver function

        Renal

          -  No inadequate renal function

          -  No hyperuricemia (greater than 8.0 mg/dL)

          -  Creatinine clearance or radioisotope glomerular filtration rate (GFR) at least 70
             mL/min OR an equivalent normal GFR OR

          -  Creatinine no greater than 1.5 times normal

        Cardiovascular

          -  Shortening fraction at least 27% by echocardiogram OR

          -  Ejection fraction at least 50% by MUGA

        Pulmonary

          -  No proven or suspected pneumonia

        Other

          -  Not pregnant or nursing

          -  No proven or suspected sepsis or meningitis

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  No prior chemotherapy except intrathecal cytarabine administered that was administered
             at diagnosis

        Endocrine therapy

          -  Prior topical and inhalation steroids allowed

          -  No concurrent steroids as antiemetics

        Radiotherapy

          -  No prior radiotherapy

        Surgery

          -  Not specified

        Other

          -  No prior antileukemic therapy

          -  No concurrent pressor agent or ventilatory support unless approved by the study chair

          -  No concurrent participation in another COG therapeutic study