Clinical trial NCT00477542 (phase 1, status: completed)
Conditions: hematologic malignancies
ICD codes: E70.338, E70.339, P09.3, O28.0, P61.8, P61.9, T45.8X1A
Drugs: clofarabine
SMILES: [H][C@@]12C[C@@H](C)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C
Eligibility criteria:

        Inclusion Criteria:

          -  Documentation of disease. Patients must have one of the following disease types:

               -  Acute myeloid leukemia (AML) with either:

                    -  Primary refractory to induction chemotherapy

                    -  Relapsed and refractory AML with >5% blasts in bone marrow or extramedullary
                       disease (excluding active disease of the central nervous system).

                    -  Patients in second or subsequent complete remission (CR2, CR3, etc.).

               -  Acute lymphoblastic leukemia (ALL) with one of the following criteria:

                    -  Primary refractory to induction chemotherapy.

                    -  Relapsed and refractory ALL with >5% blasts in bone marrow or extramedullary
                       disease (excluding active disease of the central nervous system).

                    -  Patients in second or subsequent complete remission (CR2, CR3, etc.).

               -  Myelodysplasia, refractory anemia with excess blasts with 11-20% blasts in the
                  bone marrow (RAEB II).

               -  Chronic myelogenous leukemia (CML) with one of the following criteria:

                    -  Accelerated phase.

                    -  Patients in blast crisis.

               -  Patients with aggressive non-Hodgkin's lymphoma (NHL), including diffuse large
                  cell lymphoma, mediastinal B-cell lymphoma, transformed lymphoma, mantle cell
                  lymphoma, and peripheral T cell lymphoma, who also have one of the following
                  criteria:

                    -  Failure to achieve complete remission to primary induction therapy

                    -  Relapsed NHL, refractory to at least one line of salvage systemic therapy

          -  Patients who relapse < 6 months following autologous stem cell transplantation are not
             eligible.

          -  Patient age 18-60 years

          -  Availability of a consenting HLA-matched donor

          -  Performance status ECOG 0-1

          -  No active infection. Patients with active infections requiring oral or intravenous
             antibiotics are not eligible for enrollment until resolution of infection.

          -  No HIV disease. Patients with immune dysfunction are at a significantly higher risk of
             infection from intensive immunosuppressive therapies.

          -  Non-pregnant and non-nursing. Treatment under this protocol would expose a fetus to
             significant risks. Women of childbearing potential should have a negative pregnancy
             test prior to study entry. Women and men of reproductive potential should agree to use
             an appropriate method of birth control throughout their participation in this study
             due to the teratogenic potential of the therapy utilized in this trial. Appropriate
             methods of birth control include oral contraceptives, implantable hormonal
             contraceptives (Norplant®), or double barrier method (diaphragm plus condom).

          -  Required baseline laboratory values:

               -  LVEF > 45% corrected

               -  DLCO > 50% of predicted value (corrected for hemoglobin)

               -  Serum creatinine ≤ 2.0 mg/dl or estimated creatinine clearance of ≥60 ml/min

               -  Bilirubin < 1 x upper limit of normal value

               -  AST and ALT < 1 x upper limit of normal value

          -  Signed written informed consent. Patient must be capable of understanding the
             investigational nature of the investigational nature, potential risks and benefits of
             the study, and able to provide valid informed consent.

        Exclusion Criteria:

          -  Patients who relapse < 6 months following autologous stem cell transplantation are not
             eligible