Clinical trial NCT00602225 (phase 1/phase 2, status: completed)
Conditions: acute myeloid leukemia, adult acute myeloid leukemia with 11q23 (mll) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute promyelocytic leukemia (m3), recurrent adult acute myeloid leukemia
ICD codes: C92.A1, C92.A2, C92.61, C92.62, C92.A0, C92.60, R19.5, H35.09, M26.50, M26.59, Q99.8, R06.89, R06.9, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2
Drugs: clofarabine, cytarabine
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, ClCCN(CCCl)P1(=O)NCCCO1
Eligibility criteria:

        Inclusion Criteria:

          -  ECOG performance status 0-2

          -  Capable of understanding the investigational nature, potential risks and benefits of
             the study, and able to provide valid informed consent

          -  Female patients of childbearing potential must have a negative serum pregnancy test
             within 2 weeks prior to enrollment

          -  Male and female patients must be willing to use an effective contraceptive method
             during the study and for a minimum of 6 months after study treatment

          -  Serum Total or Direct bilirubin =< 1.5 times upper limit of normal (ULN)

          -  Aspartate transaminase (AST)/alanine transaminase (ALT) =< 2.5 times ULN

          -  Diagnosis of acute myeloid leukemia by WHO criteria, either relapsed or refractory;
             acute promyelocytic leukemia [acute promyelocytic leukemia with t(15;17)(q22;q12) and
             variants] would be eligible only after failure of a regimen containing arsenic
             trioxide

          -  Serum creatinine =< 1.0 mg/dL; if serum creatinine > 1.0 mg/dl, then the estimated
             glomerular filtration rate (GFR) must be >60 mL/min/1.73 m^2

          -  Alkaline phosphatase =< 2.5 times ULN

        Exclusion Criteria:

          -  Use of investigational agents within 30 days or initiation of any other anticancer
             therapy within 2 weeks before study entry with the exception of hydroxyurea, and
             intrathecal therapy for leukemic meningitis

          -  Patients with a systemic fungal, bacterial, viral, or other infection not controlled
             (defined as exhibiting ongoing signs/symptoms related to the infection and without
             improvement, despite appropriate antibiotics or other treatment)

          -  Pregnant or lactating patients

          -  Any significant concurrent disease, illness, or psychiatric disorder that would
             compromise patient safety or compliance, interfere with consent, study participation,
             follow up, or interpretation of study results

          -  Have any other severe concurrent disease, history of serious organ dysfunction, or
             disease involving the heart, kidney, liver (including symptomatic hepatitis,
             veno-occlusive disease, or hepatic graft-versus-host disease [for acute >= grade 2]),
             or other organ system dysfunction

          -  No concomitant cytotoxic therapy or investigational therapy is allowed during the
             study with the exception of intrathecal therapy for leukemic meningitis; intrathecal
             therapy must not be given during or within 24 hours of any 5 day
             Clofarabine/Cytarabine treatment period

          -  To the extent possible, use of nephrotoxic (e.g., vancomycin, amphotericin B, etc) and
             hepatotoxic (e.g., voriconazole, cyclosporine, etc) agents is to be avoided during
             clofarabine; use of alternative medications (e.g., herbal or botanical for anticancer
             purposes) is not permitted during the entire study period

          -  Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as
             specified in the protocol

          -  More than two failed induction attempts for initial diagnosis or current relapse; for
             patients enrolled under part III of the protocol, patients must be at first salvage
             after relapse less than one year from complete remission, or salvage after initial
             induction chemotherapy

          -  Allogeneic transplant recipients on immunosuppression or on treatment for GVHD