0 Ratings

ID

14844

Description

A Study of the Histone-deacetylase Inhibitor JNJ-26481585 in Patients With Advanced or Refractory Leukemia or Myelodysplastic Syndrome; ODM derived from: https://clinicaltrials.gov/show/NCT00676728

Link

https://clinicaltrials.gov/show/NCT00676728

Keywords

  1. 5/1/16 5/1/16 -
Uploaded on

May 1, 2016

DOI

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License

Creative Commons BY 4.0

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    Eligibility Advanced or Refractory Leukemia NCT00676728

    Eligibility Advanced or Refractory Leukemia NCT00676728

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    histologically or cytologically confirmed advanced or refractory acute myeloid leukemia, acute lymphocytic leukemia, chronic myeloid leukemia in blast phase, refractory chronic lymphocytic leukemia, myelodysplastic syndrome, or chronic myelomonocytic leukemia
    Description

    acute myeloid leukemia, acute lymphocytic leukemia

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023440 (Acute Erythroblastic Leukemia)
    SNOMED
    14317002
    UMLS CUI [2]
    C0023449 (Acute lymphocytic leukemia)
    SNOMED
    91857003
    LOINC
    LA31346-2
    myelodysplastic syndrome
    Description

    myelodysplastic syndrome

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3463824 (MYELODYSPLASTIC SYNDROME)
    SNOMED
    109995007
    eastern cooperative oncology group performance status score 0, 1 or 2
    Description

    ecog

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    left ventricular ejection fraction greater than or equal to 50%
    Description

    left ventricular ejection fraction

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0428772 (Left ventricular ejection fraction)
    SNOMED
    250908004
    negative hepatitis b, c and human immunodeficiency virus (hiv) test within last 3 months
    Description

    negative hepatitis b, c and human immunodeficiency virus (hiv)

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2711110 (Hepatitis B and hepatitis C)
    SNOMED
    442374005
    UMLS CUI [2]
    C0019693 (HIV Infections)
    SNOMED
    86406008
    adequate liver and kidney function
    Description

    liver and kidney function

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0232741 (Liver function)
    SNOMED
    79036002
    LOINC
    LP31397-0
    UMLS CUI [1,2]
    C0232804 (Renal function)
    SNOMED
    11953005
    LOINC
    LP31398-8
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    known or suspected involvement of the central nervous system
    Description

    involvement of the central nervous system

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0449389 (CNS involvement status)
    SNOMED
    260766009
    chemotherapy (nitrosoureas and mitomycin c within 6 weeks), radiotherapy, immunotherapy or treatment with investigative agent within 3 weeks before study drug administration (except hydroxyurea which should be stopped at least 24 hours prior to first dose)
    Description

    chemotherapy, radiotherapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    UMLS CUI [2]
    C1522449 (Therapeutic radiology procedure)
    SNOMED
    53438000
    LOINC
    LA4351-8
    unstable angina or myocardial infarction within the preceding 12 months; congestive heart failure
    Description

    unstable angina or myocardial infarction, congestive heart failure

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0018802 (Congestive heart failure)
    SNOMED
    42343007
    LOINC
    MTHU020787
    UMLS CUI [2]
    C0027051 (Myocardial Infarction)
    SNOMED
    22298006
    UMLS CUI [3]
    C0002965 (Angina, Unstable)
    SNOMED
    4557003
    poorly controlled hypertension or diabetes, ongoing active infection and psychiatric illness
    Description

    hypertension or diabetes

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0020538 (Hypertensive disease)
    SNOMED
    38341003
    LOINC
    MTHU020789
    UMLS CUI [2]
    C0020538 (Hypertensive disease)
    SNOMED
    38341003
    LOINC
    MTHU020789
    receiving medications known to have a risk of causing qtc prolongation
    Description

    qtc prolongation

    Data type

    boolean

    Similar models

    Eligibility Advanced or Refractory Leukemia NCT00676728

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    acute myeloid leukemia, acute lymphocytic leukemia
    Item
    histologically or cytologically confirmed advanced or refractory acute myeloid leukemia, acute lymphocytic leukemia, chronic myeloid leukemia in blast phase, refractory chronic lymphocytic leukemia, myelodysplastic syndrome, or chronic myelomonocytic leukemia
    boolean
    C0023440 (UMLS CUI [1])
    C0023449 (UMLS CUI [2])
    myelodysplastic syndrome
    Item
    myelodysplastic syndrome
    boolean
    C3463824 (UMLS CUI [1])
    ecog
    Item
    eastern cooperative oncology group performance status score 0, 1 or 2
    boolean
    C1520224 (UMLS CUI [1])
    left ventricular ejection fraction
    Item
    left ventricular ejection fraction greater than or equal to 50%
    boolean
    C0428772 (UMLS CUI [1])
    negative hepatitis b, c and human immunodeficiency virus (hiv)
    Item
    negative hepatitis b, c and human immunodeficiency virus (hiv) test within last 3 months
    boolean
    C2711110 (UMLS CUI [1])
    C0019693 (UMLS CUI [2])
    liver and kidney function
    Item
    adequate liver and kidney function
    boolean
    C0232741 (UMLS CUI [1,1])
    C0232804 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    involvement of the central nervous system
    Item
    known or suspected involvement of the central nervous system
    boolean
    C0449389 (UMLS CUI [1])
    chemotherapy, radiotherapy
    Item
    chemotherapy (nitrosoureas and mitomycin c within 6 weeks), radiotherapy, immunotherapy or treatment with investigative agent within 3 weeks before study drug administration (except hydroxyurea which should be stopped at least 24 hours prior to first dose)
    boolean
    C0392920 (UMLS CUI [1])
    C1522449 (UMLS CUI [2])
    unstable angina or myocardial infarction, congestive heart failure
    Item
    unstable angina or myocardial infarction within the preceding 12 months; congestive heart failure
    boolean
    C0018802 (UMLS CUI [1])
    C0027051 (UMLS CUI [2])
    C0002965 (UMLS CUI [3])
    hypertension or diabetes
    Item
    poorly controlled hypertension or diabetes, ongoing active infection and psychiatric illness
    boolean
    C0020538 (UMLS CUI [1])
    C0020538 (UMLS CUI [2])
    qtc prolongation
    Item
    receiving medications known to have a risk of causing qtc prolongation
    boolean

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