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ID

13749

Description

Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT01074047

Link

https://clinicaltrials.gov/show/NCT01074047

Keywords

Versions (1)
  1. 3/2/16 3/2/16 -
Copyright Holder

CC BY-NC 3.0

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March 2, 2016

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Creative Commons BY-NC 3.0
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    Eligibility Acute Myeloid Leukemia NCT01074047

    English

    Eligibility Acute Myeloid Leukemia NCT01074047

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    diagnosis of one of the following
    Description

    ID.1

    Data type

    boolean

    newly diagnosed de novo acute myeloid leukemia (aml)
    Description

    newly diagnosed de novo acute myeloid leukemia (aml)

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0023467
    UMLS CUI [1,2]
    C1515568
    aml secondary to myelodysplastic syndromes (mds)
    Description

    aml secondary to myelodysplastic syndromes (mds)

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0280449
    UMLS CUI [2]
    C3463824
    aml secondary to exposure to leukemogenic therapy or agents with primary malignancy in remission for at least 2 years
    Description

    aml secondary to exposure to leukemogenic therapy or agents with primary malignancy in remission for at least 2 years

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0280449
    UMLS CUI [2,1]
    C0087111
    UMLS CUI [2,2]
    C2983796
    bone marrow blasts >30%
    Description

    bone marrow blasts >30%

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1982687
    age ≥ 65 years
    Description

    age ≥ 65 years

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    easter cooperative oncology group (ecog) 0-2
    Description

    easter cooperative oncology group (ecog) 0-2

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    previous cytotoxic or biologic treatment for aml (except hydroxyurea)
    Description

    previous cytotoxic or biologic treatment for aml (except hydroxyurea)

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0023467
    UMLS CUI [1,2]
    C1514463
    UMLS CUI [2]
    C0020402
    previous treatment with azacitidine, decitabine or cytarabine
    Description

    previous treatment with azacitidine, decitabine or cytarabine

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0004475
    UMLS CUI [1,2]
    C1514463
    UMLS CUI [2,1]
    C0049065
    UMLS CUI [2,2]
    C1514463
    UMLS CUI [3,1]
    C0010711
    UMLS CUI [3,2]
    C1514463
    prior use of targeted therapy agents (e.g., flt3 inhibitors, other kinase inhibitors)
    Description

    prior use of targeted therapy agents (e.g., flt3 inhibitors, other kinase inhibitors)

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2985566
    UMLS CUI [1,2]
    C1514463
    aml french american british subtype (fab m3)
    Description

    aml french american british subtype (fab m3)

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023487
    aml associated with inv(16), t(8;21), t(16;16), t(15:17), or t(9;22) karyotypes
    Description

    aml associated with inv(16), t(8;21), t(16;16), t(15:17), or t(9;22) karyotypes

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0023467
    UMLS CUI [1,2]
    C0008625
    prior bone marrow or stem cell transplantation
    Description

    prior bone marrow or stem cell transplantation

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005961
    UMLS CUI [1,2]
    C0332152
    UMLS CUI [2,1]
    C1504389
    UMLS CUI [2,2]
    C0332152
    candidate for allogeneic bone marrow or stem cell transplant
    Description

    candidate for allogeneic bone marrow or stem cell transplant

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0005961
    UMLS CUI [2]
    C1504389
    diagnosis of malignant disease within the previous 12 months (excluding base cell carcinoma, "in-situ" carcinoma of the cervix or breast or other local malignancy excised or irradiated with a high probability of cure)
    Description

    diagnosis of malignant disease within the previous 12 months (excluding base cell carcinoma, "in-situ" carcinoma of the cervix or breast or other local malignancy excised or irradiated with a high probability of cure)

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    malignant hepatic tumors
    Description

    malignant hepatic tumors

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0345904
    uncontrolled systemic infection
    Description

    uncontrolled systemic infection

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3646020
    active viral infection with human immunodeficiency virus (hiv) or hepatitis type b or c
    Description

    active viral infection with human immunodeficiency virus (hiv) or hepatitis type b or c

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019682
    UMLS CUI [2]
    C0019163
    UMLS CUI [3]
    C0019196
    use of any experimental drug or therapy within 28 days prior to day 1
    Description

    use of any experimental drug or therapy within 28 days prior to day 1

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0304229
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    Similar models

    Eligibility Acute Myeloid Leukemia NCT01074047

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    ID.1
    Item
    diagnosis of one of the following
    boolean
    de novo aml
    Item
    newly diagnosed de novo acute myeloid leukemia (aml)
    boolean
    C0023467 (UMLS CUI [1,1])
    C1515568 (UMLS CUI [1,2])
    secondary AML
    Item
    aml secondary to myelodysplastic syndromes (mds)
    boolean
    C0280449 (UMLS CUI [1])
    C3463824 (UMLS CUI [2])
    secondary aml to leukemogenic therapy
    Item
    aml secondary to exposure to leukemogenic therapy or agents with primary malignancy in remission for at least 2 years
    boolean
    C0280449 (UMLS CUI [1])
    C0087111 (UMLS CUI [2,1])
    C2983796 (UMLS CUI [2,2])
    bone marrow blasts
    Item
    bone marrow blasts >30%
    boolean
    C1982687 (UMLS CUI [1])
    age
    Item
    age ≥ 65 years
    boolean
    C0001779 (UMLS CUI [1])
    ECOG
    Item
    easter cooperative oncology group (ecog) 0-2
    boolean
    C1520224 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    prior therapy for aml
    Item
    previous cytotoxic or biologic treatment for aml (except hydroxyurea)
    boolean
    C0023467 (UMLS CUI [1,1])
    C1514463 (UMLS CUI [1,2])
    C0020402 (UMLS CUI [2])
    previous treatment with azacitidine, decitabine or cytarabine
    Item
    previous treatment with azacitidine, decitabine or cytarabine
    boolean
    C0004475 (UMLS CUI [1,1])
    C1514463 (UMLS CUI [1,2])
    C0049065 (UMLS CUI [2,1])
    C1514463 (UMLS CUI [2,2])
    C0010711 (UMLS CUI [3,1])
    C1514463 (UMLS CUI [3,2])
    prior use of targeted therapy agents
    Item
    prior use of targeted therapy agents (e.g., flt3 inhibitors, other kinase inhibitors)
    boolean
    C2985566 (UMLS CUI [1,1])
    C1514463 (UMLS CUI [1,2])
    AML m3
    Item
    aml french american british subtype (fab m3)
    boolean
    C0023487 (UMLS CUI [1])
    aml cytogenetics
    Item
    aml associated with inv(16), t(8;21), t(16;16), t(15:17), or t(9;22) karyotypes
    boolean
    C0023467 (UMLS CUI [1,1])
    C0008625 (UMLS CUI [1,2])
    prior bone marrow or stem cell transplantation
    Item
    prior bone marrow or stem cell transplantation
    boolean
    C0005961 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C1504389 (UMLS CUI [2,1])
    C0332152 (UMLS CUI [2,2])
    candidate for allogeneic bone marrow or stem cell transplant
    Item
    candidate for allogeneic bone marrow or stem cell transplant
    boolean
    C0005961 (UMLS CUI [1])
    C1504389 (UMLS CUI [2])
    malignant disease
    Item
    diagnosis of malignant disease within the previous 12 months (excluding base cell carcinoma, "in-situ" carcinoma of the cervix or breast or other local malignancy excised or irradiated with a high probability of cure)
    boolean
    C0006826 (UMLS CUI [1])
    malignant neoplasm of the liver
    Item
    malignant hepatic tumors
    boolean
    C0345904 (UMLS CUI [1])
    uncontrolled systemic infection
    Item
    uncontrolled systemic infection
    boolean
    C3646020 (UMLS CUI [1])
    hiv, hepatitis b or c
    Item
    active viral infection with human immunodeficiency virus (hiv) or hepatitis type b or c
    boolean
    C0019682 (UMLS CUI [1])
    C0019163 (UMLS CUI [2])
    C0019196 (UMLS CUI [3])
    experimental drug use
    Item
    use of any experimental drug or therapy within 28 days prior to day 1
    boolean
    C0304229 (UMLS CUI [1])
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