Clinical trial NCT00301912 (phase 2, status: withdrawn)
Conditions: anemia, chronic myeloproliferative disorders, leukemia, lymphoma, multiple myeloma and plasma cell neoplasm, myelodysplastic syndromes, myelodysplastic/myeloproliferative diseases
ICD codes: D53.2, D64.9, D46.4, D53.0, D53.9, D61.3, D61.9, D47.1, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, C96.20, C96.29, D47.09, D46.9, D46.C, D46.Z
Drugs: busulfan, fludarabine phosphate, methotrexate, tacrolimus
SMILES: CS(=O)(=O)OCCCCOS(C)(=O)=O, NC1=NC(F)=NC2=C1N=CN2[C@@H]1O[C@H](CO)[C@@H](O)[C@@H]1O, 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: 
    withdrawn because study never opened to accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of 1 of the following hematopoietic disorders:

               -  Chronic myelogenous leukemia (CML), meeting 1 of the following criteria:

                    -  Chronic phase disease failing imatinib mesylate therapy

                         -  Progressive disease OR failed to achieve a major cytogenetic response
                            at 1 year after initiation of therapy

                    -  Accelerated phase disease, meeting 1 of the following criteria:

                         -  Failed to achieve complete cytogenetic remission at 1 year after
                            initiation of therapy

                         -  Failed to achieve any cytogenetic response at 3 or 6 months during
                            therapy

                         -  Progressive disease, demonstrated by worsening cytogenetic response in
                            2 consecutive analyses separated by 4 weeks

                    -  Blast crisis with < 10% blasts in bone marrow within 6 weeks of
                       transplantation

               -  Acute myeloid leukemia (AML), meeting 1 of the following criteria:

                    -  In second or greater remission

                    -  In first remission with poor prognosis cytogenetics [-5, -5q, -7, -7q and ≥
                       2 cytogenetic abnormalities, t(6,9), t(9,11), or Philadelphia chromosome]

                    -  In hematologic remission but with persistent cytogenetic abnormalities

                    -  Primary refractory AML with < 10% blasts in bone marrow within 6 weeks of
                       transplantation

               -  Myelodysplasia with < 20% blasts in bone marrow within 6 weeks of transplantation
                  and meeting 1 of the following criteria:

                    -  Advanced disease (International Prognostic Scoring System [IPSS] score
                       intermediate-1, intermediate-2, or high risk)

                    -  Myelodysplastic syndromes (MDS) with progression to AML

                    -  Treatment-related AML

               -  Acute lymphocytic leukemia (ALL), meeting 1 of the following criteria:

                    -  In second or greater remission

                    -  In first remission with high-risk cytogenetics [Philadelphia chromosome;
                       t(4,11); and -7]

                    -  Primary refractory ALL with < 10% blasts in the bone marrow

               -  Severe aplastic anemia that has failed immunosuppressive therapy

               -  Non-Hodgkin's lymphoma, meeting 1 of the following criteria:

                    -  In second or greater remission

                    -  Relapsed disease in a patient not eligible for autologous stem cell
                       transplantation

               -  Lymphoproliferative disease (e.g., chronic lymphocytic leukemia or Waldenstrom's
                  macroglobulinemia), meeting 1 of the following criteria:

                    -  In second or greater remission

                    -  Relapsed disease in a patient not eligible for autologous stem cell
                       transplantation

               -  Multiple myeloma, meeting 1 of the following criteria:

                    -  Stage II or III disease in first or greater relapse

                    -  Refractory disease

                    -  Newly diagnosed disease with chromosome 13 abnormalities

               -  Advanced myeloproliferative disease, meeting 1 of the following criteria:

                    -  Myelofibrosis requiring > 2 units of packed red blood cells each month

                    -  Essential thrombocythemia or polycythemia rubra vera that has progressed to
                       AML

                    -  Failed prior AML therapy

          -  No active, uncontrolled CNS leukemia

          -  Not eligible for autologous or mini-allogeneic transplantation

          -  No fully matched or single-antigen mismatched sibling donor available

          -  HLA-matched unrelated donor available

               -  HLA typed at HLA-A, -B, -C, -DRB1 and/or -DQB1 by high-resolution techniques

               -  For patients without HLA identical donors, mismatches at DQ (i.e., 8/8 match) and
                  1 additional mismatch at the allele level at HLA-A, -B, -C, or -DRB1 (i.e., 7/8
                  molecular match) allowed

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Creatinine < 2.0 mg/dL

          -  Pulmonary diffusing capacity > 40% of predicted

          -  Cardiac ejection fraction > 40% by MUGA or echocardiography

          -  No active liver disease

          -  Bilirubin ≤ 2.0 mg/dL

          -  Alkaline phosphatase < 3 times upper limit of normal (ULN)

          -  AST < 3 times ULN

          -  Hepatitis C or active hepatitis B (HBV) allowed provided a liver biopsy is performed
             and ≤ grade 2 inflammation is present

               -  Patients with active HBV viral replication must receive antiviral therapy

          -  HIV negative

          -  No ongoing active infection

          -  Not pregnant or nursing

          -  Negative pregnancy test

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  More than 3 weeks since prior chemotherapy except for hydroxyurea or imatinib mesylate

          -  More than 3 months since prior interferon