Clinical trial NCT00852709 (phase 1, status: terminated)
Conditions: myelodysplastic syndrome, acute myeloid leukemia, myeloproliferative disorders, acute lymphocytic leukemia, acute promyelocytic leukemia, acute leukemia, chronic myelogenous leukemia, myelofibrosis, chronic myelomonocytic leukemia, juvenile myelomonocytic leukemia
ICD codes: D46.9, D46.C, D46.Z, C92.A1, C92.A2, C92.61, C92.62, C92.A0, C92.60, D47.1, A87.2, K52.832, D72.111, C91.11, C91.12, C91.10, C92.41, C92.42, C92.40, C91.01, C91.02, C92.01, C92.02, C92.41, C92.42, C92.51, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, D75.81, C94.41, C94.42, C94.40, C93.11, C93.12, C93.10, C93.31, C93.32, C93.30
Drugs: clofarabine, cyclophosphamide
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
Reason stopped: 
    lack of accrual
  
Eligibility criteria:

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 for
             adolescent/young adult patients.

          -  Lansky Performance Index > 50 for pediatric patients less than age 10 years.

          -  Laboratory values obtained < 7 days prior to receiving study treatment:

          -  Total bilirubin < 1.5 mg/dL unless elevated due to hemolysis. The conjugated serum
             bilirubin prior to study entry must be within the normal range.

          -  Aspartate transaminase (AST) and alanine transaminase (ALT) < 2.5 × upper limit of
             normal (ULN)

          -  Serum creatinine < 1.0 mg/dL in adolescent/young adults (patients 12 to 17 years of
             age). For pediatric patients with serum creatinine above the ULN, creatinine clearance
             > 90 ml/min/1.73m2 calculated using the Schwartz formula may be enrolled. Collected
             creatinine clearance may be substituted.

        Patients 18 years and older (Adult population): 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 m2

          -  Cardiac function must be normal per the institution normal as measured by
             echocardiogram (ECHO) within 7 days.

          -  Patients should have no evidence of myositis as detected by abnormal serum creatine
             kinase and/or myoglobin.

        Exclusion Criteria:

          -  No chemotherapy, radiation, or major surgery within 2 weeks prior to first dose of
             study drug except for 5-azacytidine, thalidomide, hydroxyurea, imatinib (Gleevec), and
             interferon which must be discontinued at least 3 days before study entry and the
             patient should have recovered from the toxic side effects of such therapy. In the
             instance of progressive disease, anti-leukemia therapy may have been administered
             within the 2-week period as long but the subject should have recovered from the toxic
             effects of that therapy. Also, intrathecal therapy may be administered within the
             2-week period for subjects with CNS disease.

          -  Patients who have had an allogeneic or autologous hematopoietic stem cell transplant.

          -  Patients must have discontinued all growth factors, except Procrit (epoetin), at least
             1 week before study.

          -  Patients with known HIV positive status or AIDS.

          -  Patients with known active Hepatitis B, Hepatitis C or cirrhosis.

          -  History of severe coronary artery disease, including myocardial infarction within the
             previous 3 months, arrhythmias other than atrial flutter or fibrillation requiring
             medication, or uncontrolled congestive heart failure.

          -  Patients with active uncontrolled infection, fever of infection, or evidence for
             progressive disease by CT scans of the lungs, sinuses, or abdomen. Patients who are on
             antimicrobial therapy and stable, CT scans must have been stable for 4 weeks, may be
             enrolled but there must be no evidence of an active infection. Patients with fever due
             to leukemia may be enrolled.

          -  Pregnant or lactating patients. Female patients of childbearing potential must have a
             negative serum pregnancy test within 14 days before study entry.