Clinical trial NCT00002961 (phase 3, status: terminated)
Conditions: leukemia
ICD codes: C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01
Drugs: cyclophosphamide, cyclosporine, etoposide, methotrexate, busulfan, mesna
SMILES: 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, 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, CS(=O)(=O)OCCCCOS(C)(=O)=O, OS(=O)(=O)CCS
Reason stopped: 
    poor accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS: Histologically confirmed childhood acute lymphoblastic leukemia
        (ALL) in second hematologic remission or greater who have relapsed: On therapy OR Within
        one year of discontinuation of therapy OR Greater than 1 year from discontinuation of high
        risk intensive therapy (matched sibling donor only) Patients with central nervous system or
        testicular relapse: Occurred within 18 months of diagnosis OR Following prophylactic or
        therapeutic cranial irradiation T cell disease with isolated central nervous system (CNS)
        or bone marrow relapse at any time Patients in first remission with greater than 4 weeks to
        achieve remission or with high risk features such as: t(4,11) t(9,22) Hypodiploidy Patients
        under 12 months of age in first remission with any of the following features at diagnosis:
        CALLA (CD10) negative white blood count (WBC) at least 100,000/mm3 Day 14 M2 or M3 bone
        marrow CNS disease

        PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Not specified Life
        expectancy: Not specified Hematopoietic: Not specified Hepatic: No active hepatitis B or C
        Bilirubin no greater than 1.5 times normal Alanine aminotransferase (ALT) or aspartate
        aminotransferase (AST) less than 2.5 times normal Renal: Creatinine no greater than 1.5
        times normal OR Creatinine clearance at least 65 mL/min Cardiovascular: Shortening fraction
        greater than 27% by echocardiogram OR Ejection fraction greater than 47% by radionuclide
        angiogram Pulmonary: [1] forced expiratory volume at one second (FEV1)/forced vital
        capacity (FVC) greater than 60% For uncooperative children: No evidence of dyspnea at rest
        No exercise intolerance Pulse oximetry greater than 94% Other: No active infection No
        occult untreated infection HIV negative Not eligible for Children's Cancer Group (CCG) or
        Pediatric Oncology Group (POG) transplant study Donor criteria: Genotypically matched
        sibling or phenotypically matched family member (bone marrow or peripheral blood stem cells
        may be used) One antigen mismatched related donor Matched or one antigen mismatched
        unrelated donor Cord blood (genotypic or phenotypic match or one antigen mismatch) Matched
        sibling or phenotypically matched family member peripheral stem cells

        PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified
        Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified