Clinical trial NCT01567059 (phase 2, status: completed)
Conditions: acute myeloid leukemia with multilineage dysplasia, adult acute myeloid leukemia with 11q23 (mll) abnormalities, adult acute myeloid leukemia with del(5q), adult acute myeloid leukemia with t(15;17)(q22;q12), de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary acute myeloid leukemia, secondary myelodysplastic syndromes, untreated adult acute myeloid leukemia
ICD codes: 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, D46.Z, D46.9, C94.6, D46.C, D46.Z, D46.9, C94.6, D46.C, D75.1, E26.1, N91.1, N91.4, N94.5, A51.41, A51.43, D46.Z, D46.9, C94.6, D46.C, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01
Drugs: tosedostat, cytarabine, decitabine
SMILES: CC(C)C[C@H]([C@H](O)C(=O)NO)C(=O)N[C@H](C(=O)OC1CCCC1)C1=CC=CC=C1, ClCCN(CCCl)P1(=O)NCCCO1, CN(C)\N=N\C1=C(N=CN1)C(N)=O
Eligibility criteria:

        Inclusion Criteria:

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

          -  All adults >= 60 years of age with untreated AML or high-risk MDS (10-19% marrow
             blasts) including those with prior myelodysplasia (MDS)/AML, therapy-related AML, AML
             with trilineage dysplasia (AML-TLD), and AML with adverse cytogenetics; patients may
             be enrolled if they received prior treatment with hydroxyurea to control blood counts
             or demethylating agents specifically for the purpose of treating MDS

          -  Adults age 18 to 59 with untreated AML or high-risk MDS and a transplant-related
             mortality (TRM) score of >= 9.2; previous data suggests these people would have a 25%
             mortality with standard therapy, making this treatment a reasonable alternative

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 2

          -  Serum creatinine =< 2.0 mg/dL; if serum creatinine > 2.0 mg/dL, then the estimated
             glomerular filtration rate (GFR) must be > 50 mL/min/1.73 m^2 as calculated by the
             Modification of Diet in Renal Disease equation

          -  Serum bilirubin =< 1.5 × upper limit of normal (ULN) (in the absence of Gilbert's
             syndrome)

          -  Aspartate transaminase (AST)/alanine transaminase (ALT) =< 3.0 × ULN

          -  Alkaline phosphatase =< 2.5 × ULN

          -  Male subjects, even if surgically sterilized (i.e., status postvasectomy) must agree
             to 1 of the following: practice effective barrier contraception during the entire
             study treatment period and through a minimum of 30 days after the last dose of study
             drug, or completely abstain from heterosexual intercourse

          -  Female subject is either postmenopausal for at least 1 year before the screening
             visit, is surgically sterilized or if they are of childbearing potential, agree to
             practice 2 effective methods of contraception from the time of signing the informed
             consent form through 30 days after the last dose of study drug, or agree to completely
             abstain from heterosexual intercourse

        Exclusion Criteria:

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

          -  Active uncontrolled infection

          -  Known infection with human immunodeficiency virus (HIV)

          -  Medical condition, serious concurrent illness, or other extenuating circumstance that,
             in the judgment of the Principal Investigator, could jeopardize patient safety or
             interfere with the objectives of the study

          -  Uncontrolled angina or myocardial infarction within 6 months; patients with recent
             myocardial infarction apparently due to medical causes unrelated to underlying cardiac
             abnormalities must have a cardiac consult, and be cleared to participate in the
             research by the cardiologist prior to initiation of treatment and may be enrolled at
             the discretion of the primary investigator (PI) and treating physician

          -  Current or history of congestive heart failure New York Heart Association (NYHA) class
             3 or 4, unless a screening echocardiogram (ECHO) or multiple gate acquisition scan
             (MUGA) performed within 1 month prior to study screening results in a left ventricular
             ejection fraction (LVEF) that is >= 45% (or institutional lower limit of normal value)

          -  Diagnosed or treated for another malignancy within 1 year of enrollment, with the
             exception of complete resection of basal cell carcinoma or squamous cell carcinoma of
             the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy