Clinical trial NCT00372593 (phase 3, status: completed)
Conditions: leukemia
ICD codes: C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01
Drugs: asparaginase, cytarabine, daunorubicin hydrochloride, etoposide, gemtuzumab ozogamicin, mitoxantrone hydrochloride
SMILES: N[C@@H](CC(O)=O)C(O)=O, 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, OCCNCCNC1=CC=C(NCCNCCO)C2=C1C(=O)C1=C(C(O)=CC=C1O)C2=O
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Newly diagnosed acute myeloid leukemia (AML)

               -  Meets customary criteria for AML with ≥ 20% bone marrow blasts (by WHO
                  classification)

                    -  Patients with < 20% bone marrow blasts and cytopenia or myelodysplastic
                       syndromes (e.g., chronic myelomonocytic leukemia, refractory anemia (RA), RA
                       with excess blasts, RA with ringed sideroblasts) are eligible provided 1 of
                       the following criteria is met:

                         -  Karyotypic abnormality characteristic of de novo AML (t[8;21][q22;q22],
                            inv[16][p13q22], t[16;16][p13;q22], or 11q23 abnormalities)

                         -  Unequivocal presence of megakaryoblasts (by WHO classification)

               -  Isolated myeloid sarcoma (i.e., myeloblastoma or chloroma) allowed regardless of
                  bone marrow results

          -  Infants < 1 month of age with progressive disease* are eligible NOTE: *Infants < 1
             month of age with AML may be given supportive care until it is clear that the leukemia
             is not regressing (i.e., the disappearance of peripheral blasts and the normalization
             of peripheral blood counts)

          -  Patients with Down syndrome ≥ 4 years of age are eligible

          -  No juvenile myelomonocytic leukemia

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

          -  No promyelocytic leukemia (M3)

          -  No secondary or treatment-related AML

          -  Matched family donor criteria (for patients with intermediate-risk or high-risk
             disease):

               -  HLA-A, -B, -C, and beta chain (-DRB1), identical or 1 antigen or allele
                  mismatched by molecular high resolution technique

               -  All available first-degree family members (parents and siblings) must be HLA
                  typed

               -  No syngeneic donors

          -  Matched alternative donor criteria (for patients with high-risk disease):

               -  HLA-A, -B, -C, and -DRB1, identical or 1 antigen or allele mismatched donor

               -  HLA-A, -B, and -DRB1 4 of 6 antigen matched unrelated cord blood donor

               -  Mismatched family member donor with ≥ 1 haplotype match or 5 of 6 antigen
                  phenotypic match

        PATIENT CHARACTERISTICS:

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

          -  No prior chemotherapy, radiation therapy, or any antileukemic therapy

               -  Topical or inhalation steroids for other conditions allowed

               -  Intrathecal cytarabine given at diagnosis allowed

          -  No other prior treatment for AML

          -  No concurrent peripheral blood stem cell transplantation in patients with matched
             family donor