Clinical trial NCT00253513 (phase 1/phase 2, status: completed)
Conditions: leukemia, myelodysplastic syndromes
ICD codes: C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, D46.9, D46.C, D46.Z
Drugs: fludarabine, treosulfan
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, CS(=O)(=O)OC[C@H](O)[C@@H](O)COS(C)(=O)=O
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of acute myeloid leukemia, lymphoblastic leukemia, or myelodysplastic
             syndrome

               -  Any phase allowed, including any of the following:

                    -  Disease in remission

                    -  Relapsed or primary refractory disease

          -  No CNS leukemic involvement not clearing with prior intrathecal chemotherapy and/or
             cranial radiotherapy

          -  Planning to undergo unmanipulated allogeneic bone marrow or peripheral blood stem cell
             transplantation

               -  Filgrastim (G-CSF) mobilization of bone marrow or stem cells allowed

          -  Donor available, meeting 1 of the following criteria:

               -  HLA-identical related donor

               -  HLA-A, -B, -C, -DRB1, and -DQB1 matched unrelated donor by high-resolution DNA
                  typing

                    -  A single allele mismatch allowed

        PATIENT CHARACTERISTICS:

        Performance status

          -  Karnofsky 70-100% OR

          -  Lansky 70-100%

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Not specified

        Hepatic

          -  Bilirubin ≤ 2 times upper limit of normal (ULN)

          -  AST ≤ 2 times ULN

          -  No evidence of synthetic dysfunction

          -  No severe cirrhosis

          -  No active infectious hepatitis

        Renal

          -  Creatinine clearance ≥ 50%

          -  Creatinine ≤ 2 times ULN

          -  Dialysis independent

        Cardiovascular

          -  No cardiac insufficiency requiring treatment

          -  No symptomatic coronary artery disease

          -  Ejection fraction ≥ 35% (for patients with history of cardiac disease or anthracycline
             exposure)

        Pulmonary

          -  PO_2 ≥ 70 mm Hg AND DLCO ≥ 70% of predicted OR

          -  PO_2 ≥ 80 mm Hg AND DLCO ≥ 60% of predicted

          -  Not requiring supplementary continuous oxygen

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No other disease that would severely limit life expectancy

          -  No HIV positivity

          -  No active infection requiring deferral of conditioning

          -  No known hypersensitivity to the study drugs

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  See Disease Characteristics

          -  No prior allogeneic bone marrow or stem cell transplantation

          -  No concurrent umbilical cord blood or autologous transplantation

        Chemotherapy

          -  See Disease Characteristics

        Radiotherapy

          -  See Disease Characteristics

        Other

          -  More than 4 weeks since prior experimental drugs

          -  Concurrent enrollment on another protocol for graft-versus-host disease prophylaxis
             allowed