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ID

14844

Beschreibung

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

Stichworte

  1. 01.05.16 01.05.16 -
Hochgeladen am

1. Mai 2016

DOI

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Lizenz

Creative Commons BY 4.0

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    Eligibility Advanced or Refractory Leukemia NCT00676728

    Eligibility Advanced or Refractory Leukemia NCT00676728

    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    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
    Beschreibung

    acute myeloid leukemia, acute lymphocytic leukemia

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0023440
    UMLS CUI [2]
    C0023449
    myelodysplastic syndrome
    Beschreibung

    myelodysplastic syndrome

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C3463824
    eastern cooperative oncology group performance status score 0, 1 or 2
    Beschreibung

    ecog

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    left ventricular ejection fraction greater than or equal to 50%
    Beschreibung

    left ventricular ejection fraction

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0428772
    negative hepatitis b, c and human immunodeficiency virus (hiv) test within last 3 months
    Beschreibung

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

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2711110
    UMLS CUI [2]
    C0019693
    adequate liver and kidney function
    Beschreibung

    liver and kidney function

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0232741
    UMLS CUI [1,2]
    C0232804
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    known or suspected involvement of the central nervous system
    Beschreibung

    involvement of the central nervous system

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0449389
    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)
    Beschreibung

    chemotherapy, radiotherapy

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    UMLS CUI [2]
    C1522449
    unstable angina or myocardial infarction within the preceding 12 months; congestive heart failure
    Beschreibung

    unstable angina or myocardial infarction, congestive heart failure

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0018802
    UMLS CUI [2]
    C0027051
    UMLS CUI [3]
    C0002965
    poorly controlled hypertension or diabetes, ongoing active infection and psychiatric illness
    Beschreibung

    hypertension or diabetes

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0020538
    UMLS CUI [2]
    C0020538
    receiving medications known to have a risk of causing qtc prolongation
    Beschreibung

    qtc prolongation

    Datentyp

    boolean

    Ähnliche Modelle

    Eligibility Advanced or Refractory Leukemia NCT00676728

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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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