ID

13254

Beschreibung

Safety & Efficacy Study of Oral Panobinostat (LBH589) With Chemotherapy in Patients < 65 Years Old With Acute Myeloid Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT01242774

Link

https://clinicaltrials.gov/show/NCT01242774

Stichworte

  1. 26.01.16 26.01.16 -
Rechteinhaber

CC BY-NC 3.0

Hochgeladen am

26. Januar 2016

DOI

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Creative Commons BY-NC 3.0

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    Eligibility Acute Myeloid Leukemia (AML) NCT01242774

    Eligibility Acute Myeloid Leukemia (AML) NCT01242774

    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    newly diagnosed adult patients = 65 years old with a cytopathologically confirmed diagnosis of high-risk aml
    Beschreibung

    AML

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0023467
    = 20% bone marrow blasts via bone marrow aspiration or biopsy
    Beschreibung

    bone marrow blasts

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0368761
    the patient has not yet been treated for aml
    Beschreibung

    prior treatment for aml

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0087111
    1º or 2º aml patients with high-risk category features
    Beschreibung

    high-risk category

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0086930
    ecog ps = 2
    Beschreibung

    ECOG

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    renal function and liver function limits.
    Beschreibung

    renal and hepatic function

    Datentyp

    boolean

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

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patient with a 'favorable' or 'better-risk' cytogenetic profile = t(15;17); t(8;21); or inv(16) or t(16;16)
    Beschreibung

    cytogenetic profile

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0010802
    patient has clinical symptoms suggestive of cns leukemia and/or csf findings for cns leukemia
    Beschreibung

    cns leukemia

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1332884
    prior treatment with deacetylase inhibitors (daci) including, panobinostat
    Beschreibung

    deacetylase inhibitors

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1333261
    impaired cardiac function
    Beschreibung

    cardiac function

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0232164
    female patient who is pregnant or breast feeding
    Beschreibung

    pregnancy or lactation

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    male patient who is not willing to use a barrier method of contraception
    Beschreibung

    contraception

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0700589

    Ähnliche Modelle

    Eligibility Acute Myeloid Leukemia (AML) NCT01242774

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    AML
    Item
    newly diagnosed adult patients = 65 years old with a cytopathologically confirmed diagnosis of high-risk aml
    boolean
    C0023467 (UMLS CUI [1])
    bone marrow blasts
    Item
    = 20% bone marrow blasts via bone marrow aspiration or biopsy
    boolean
    C0368761 (UMLS CUI [1])
    prior treatment for aml
    Item
    the patient has not yet been treated for aml
    boolean
    C0087111 (UMLS CUI [1])
    high-risk category
    Item
    1º or 2º aml patients with high-risk category features
    boolean
    C0086930 (UMLS CUI [1])
    ECOG
    Item
    ecog ps = 2
    boolean
    C1520224 (UMLS CUI [1])
    renal and hepatic function
    Item
    renal function and liver function limits.
    boolean
    C0232804 (UMLS CUI [1])
    C0232741 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    cytogenetic profile
    Item
    patient with a 'favorable' or 'better-risk' cytogenetic profile = t(15;17); t(8;21); or inv(16) or t(16;16)
    boolean
    C0010802 (UMLS CUI [1])
    cns leukemia
    Item
    patient has clinical symptoms suggestive of cns leukemia and/or csf findings for cns leukemia
    boolean
    C1332884 (UMLS CUI [1])
    deacetylase inhibitors
    Item
    prior treatment with deacetylase inhibitors (daci) including, panobinostat
    boolean
    C1333261 (UMLS CUI [1])
    cardiac function
    Item
    impaired cardiac function
    boolean
    C0232164 (UMLS CUI [1])
    pregnancy or lactation
    Item
    female patient who is pregnant or breast feeding
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    contraception
    Item
    male patient who is not willing to use a barrier method of contraception
    boolean
    C0700589 (UMLS CUI [1])

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