Clinical trial NCT00049517 (phase 3, status: completed)
Conditions: leukemia
ICD codes: C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01
Drugs: busulfan, cyclophosphamide, cytarabine, gemtuzumab ozogamicin (go), daunorubicin
SMILES: CS(=O)(=O)OCCCCOS(C)(=O)=O, ClCCN(CCCl)P1(=O)NCCCO1, 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
Eligibility criteria:

        Inclusion Criteria:

          -  Morphologically confirmed acute myeloid leukemia (AML) (greater than 20% blasts in the
             peripheral blood or marrow) meeting any of the following criteria:

               -  Recurrent cytogenetic translocations

                    -  t(8;21)(q22;q22)

                    -  Bone marrow eosinophil abnormalities

                         -  inv(16)(p13;q22)

                         -  t(16;16)(p13;q22)

                    -  11q23 abnormalities

               -  Multilineage dysplasia without presence of myelodysplastic syndromes (MDS)

               -  Minimally differentiated AML

               -  AML without maturation

               -  AML with maturation

               -  AML not otherwise categorized

               -  Acute myelomonocytic leukemia

               -  Acute monocytic leukemia

               -  Acute erythroid leukemia

               -  Acute megakaryocytic leukemia

               -  Acute basophilic leukemia

          -  Patients undergoing allogeneic transplantation must have a sibling donor match defined
             as human leukocyte antigen (HLA) match or haplotype match with one locus mismatch on
             other haplotype

          -  Age 16 to 60

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-4

          -  Aspartate aminotransferase (AST) less than 4 times upper limit of normal (ULN)

          -  Alkaline phosphatase less than 4 times ULN

          -  Creatinine no greater than 2.0 mg/dL

          -  Creatinine clearance at least 50 mL/min

          -  Left ventricular ejection fraction (LVEF) at least 45% by post-induction multigated
             acquisition (MUGA) scan

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  HIV negative

          -  Prior hydroxyurea allowed

          -  Prior corticosteroids allowed

        Exclusion Criteria:

          -  Recurrent cytogenetic translocations

               -  Acute promyelocytic leukemia (PML) with t(15;17)(q22;q21)

               -  Variant acute PML with t(v;17)

          -  Multilineage dysplasia with prior MDS

          -  Acute panmyelosis with myelofibrosis

               -  Blastic transformation of chronic myelogenous leukemia

               -  Secondary AML (chemotherapy-induced or evolved from MDS)

               -  Pregnant or nursing

               -  Bilirubin greater than 2.0 mg/dL (unless related to Gilbert's syndrome or
                  hemolysis)

               -  Significant cardiac disease requiring active therapy (e.g., digoxin, diuretics,
                  antiarrhythmics, or antianginal medications)

               -  Prior biologic therapy

               -  Prior cytotoxic chemotherapy for any malignancy

               -  Prior radiotherapy for any malignancy