Clinical trial NCT00555048 (phase 1/phase 2, status: terminated)
Conditions: graft versus host disease, leukemia, myelodysplastic syndromes, myelodysplastic/myeloproliferative diseases
ICD codes: D89.810, D89.811, D89.813, D89.812, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, D46.9, D46.C, D46.Z
Drugs: busulfan, cyclophosphamide, methotrexate, tacrolimus
SMILES: CS(=O)(=O)OCCCCOS(C)(=O)=O, ClCCN(CCCl)P1(=O)NCCCO1, 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, COC1=CC2=C(C(OC)=C1OC)C1=CC=C(OC)C(=O)C=C1C(CC2)NC(C)=O
Reason stopped: 
    low accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Confirmed diagnosis of one of the following:

               -  Primary acute myeloid leukemia (AML) meeting any of the following criteria:

                    -  First complete remission (CR; defined as < 5% blasts in marrow) with
                       high-risk features as defined by failure to achieve remission by day 21
                       after induction chemotherapy, or the presence of chromosomal abnormalities
                       involving any of the following:

                         -  -5/del(5q)

                         -  -7/del(7q)

                         -  Inversion 3q

                         -  Abnormalities of 11q23, 20q, 21q, del(9q),

                         -  Translocation 6;9

                         -  Translocation 9;22

                         -  Abnormalities of 17p

                         -  Complex karyotype with ≥ 3 abnormalities

                    -  Second CR or subsequent in remission

                    -  Refractory or relapsed disease

               -  Secondary AML in remission or relapse

               -  Chronic myelogenous leukemia (CML) in accelerated or blast phase meeting the
                  following criteria:

                    -  Accelerated phase is defined by any one of the following:

                         -  Blasts 10% to 19% of peripheral blood white cells or bone marrow cells

                         -  Peripheral blood basophils ≥ 20%

                         -  Persistent thrombocytopenia (< 100,000/mm³) unrelated to therapy, or
                            persistent thrombocytosis (> 1,000,000/mm³) unresponsive to therapy

                         -  Increasing spleen size and increasing WBC count unresponsive to therapy

                         -  Cytogenetic evidence of clonal evolution (i.e., the appearance of an
                            additional genetic abnormality that was not present in the initial
                            specimen at the time of diagnosis of chronic phase CML)

                    -  Blast phase is defined by any of the following:

                         -  Blasts ≥ 20% of peripheral blood white cells or bone marrow cells

                         -  Extramedullary blast proliferation

                         -  Large foci or clusters of blasts in bone marrow biopsy

               -  Primary myelodysplastic syndromes (MDS) with an IPSS score > 1.5

               -  Secondary MDS with any IPSS score

               -  Primary acute lymphoblastic leukemia meeting any of the following criteria:

                    -  First CR (< 5% blasts in marrow) with high-risk features as defined by 1 of
                       the following:

                         -  Failure to achieve remission after first induction chemotherapy

                         -  Presence of chromosomal abnormalities including hypodiploidy or
                            abnormalities of 11q23 or translocation 9;22

                    -  Second CR or subsequent in remission

                    -  Refractory or relapsed disease

          -  No patients for whom a suitable HLA genotypically identical sibling or fully matched
             HLA-A, -B, -C, and -DRB1 unrelated donor is available

          -  No active CNS involvement with disease

          -  Donors must meet the following criteria:

               -  Unrelated volunteer donors who are mismatched for more than one HLA-class I
                  alleles or antigens or for one HLA-class I antigen, but matched by
                  high-resolution typing at HLA-DRB1 and -DQB1, OR who are mismatched for one or
                  more HLA-class II alleles or antigens, but matched by high-resolution typing at
                  HLA-A, -B, and -C

                    -  No two-antigen mismatch at a single HLA-A, -B, or -C locus

                    -  No mismatching of class I and class II HLA

                    -  Matching must be based on results of high-resolution typing at HLA-A, -B,
                       -C, - DRB1, and -DQB1

        PATIENT CHARACTERISTICS:

          -  Karnofsky performance status 50-100%

          -  No symptomatic coronary artery disease or symptomatic congestive heart failure

          -  No hepatic disease with transaminases or bilirubin > 2 times upper limit of normal
             except for isolated hyperbilirubinemia attributed to Gilbert's syndrome

          -  No severe hypoxemia with room air P_AO_2 < 70, supplemental oxygen-dependence, or DLCO
             < 60% predicted

          -  No impaired renal function with creatinine > 2 times upper limit of normal or
             creatinine clearance < 50% normal

          -  Not HIV seropositive

          -  Not pregnant or breast-feeding

          -  Fertile patients must use effective contraception

          -  No active infections that are untreated or failing to respond to appropriate therapy

        PRIOR CONCURRENT THERAPY:

        Inclusion criteria:

          -  See Disease Characteristics

        Exclusion criteria:

          -  Prior allogeneic or autologous bone marrow, peripheral blood stem cell, or umbilical
             cord blood transplantation using a high-dose total-body irradiation regimen