ID

13757

Description

Study of Sapacitabine in Acute Myeloid Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT01211457

Link

https://clinicaltrials.gov/show/NCT01211457

Keywords

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

CC BY-NC 3.0

Uploaded on

March 3, 2016

DOI

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License

Creative Commons BY-NC-ND 3.0
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    Eligibility Acute Myeloid Leukemia NCT01211457

    English

    Eligibility Acute Myeloid Leukemia NCT01211457

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    newly diagnosed aml based on who classification
    Description

    de novo aml

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0023467
    UMLS CUI [1,2]
    C1515568
    age 70 years or older for whom the treatment of choice is low-intensity therapy by investigator assessment or who has refused intensive induction therapy recommended by investigator
    Description

    age and chemotherapy regimen

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2]
    C0392920
    ecog performance status 0-2
    Description

    ECOG

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    adequate renal function
    Description

    renal function

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232804
    adequate liver function
    Description

    liver function

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232741
    able to swallow capsules
    Description

    capsules

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006935
    ability to understand and willingness to sign the informed consent form
    Description

    informed consent form

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    aml is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor without bone marrow involvement
    Description

    APL or extramedullary myeloid tumor

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023487
    UMLS CUI [2,1]
    C2939461
    UMLS CUI [2,2]
    C1517060
    having received any systemic anti-cancer therapy for aml or received treatment with hypomethylating agents or cytotoxic chemotherapy for the preceding mds or mpd
    Description

    prior therapy for aml

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0023467
    UMLS CUI [1,2]
    C1514463
    UMLS CUI [2,1]
    C2613367
    UMLS CUI [2,2]
    C0013227
    UMLS CUI [3]
    C0392920
    UMLS CUI [4]
    C3463824
    known central nervous system (cns) involvement by leukemia
    Description

    cns leukemia

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1332884
    uncontrolled intercurrent illness including
    Description

    comorbidity

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    known hypersensitivity to decitabine
    Description

    hypersensitivity to decitabine

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0049065
    UMLS CUI [1,2]
    C0020517
    known to be hiv-positive
    Description

    hiv

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019682
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    Similar models

    Eligibility Acute Myeloid Leukemia NCT01211457

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    de novo aml
    Item
    newly diagnosed aml based on who classification
    boolean
    C0023467 (UMLS CUI [1,1])
    C1515568 (UMLS CUI [1,2])
    age and chemotherapy regimen
    Item
    age 70 years or older for whom the treatment of choice is low-intensity therapy by investigator assessment or who has refused intensive induction therapy recommended by investigator
    boolean
    C0001779 (UMLS CUI [1])
    C0392920 (UMLS CUI [2])
    ECOG
    Item
    ecog performance status 0-2
    boolean
    C1520224 (UMLS CUI [1])
    renal function
    Item
    adequate renal function
    boolean
    C0232804 (UMLS CUI [1])
    liver function
    Item
    adequate liver function
    boolean
    C0232741 (UMLS CUI [1])
    capsules
    Item
    able to swallow capsules
    boolean
    C0006935 (UMLS CUI [1])
    informed consent form
    Item
    ability to understand and willingness to sign the informed consent form
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    APL or extramedullary myeloid tumor
    Item
    aml is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor without bone marrow involvement
    boolean
    C0023487 (UMLS CUI [1])
    C2939461 (UMLS CUI [2,1])
    C1517060 (UMLS CUI [2,2])
    prior therapy for aml
    Item
    having received any systemic anti-cancer therapy for aml or received treatment with hypomethylating agents or cytotoxic chemotherapy for the preceding mds or mpd
    boolean
    C0023467 (UMLS CUI [1,1])
    C1514463 (UMLS CUI [1,2])
    C2613367 (UMLS CUI [2,1])
    C0013227 (UMLS CUI [2,2])
    C0392920 (UMLS CUI [3])
    C3463824 (UMLS CUI [4])
    cns leukemia
    Item
    known central nervous system (cns) involvement by leukemia
    boolean
    C1332884 (UMLS CUI [1])
    comorbidity
    Item
    uncontrolled intercurrent illness including
    boolean
    C0009488 (UMLS CUI [1])
    hypersensitivity to decitabine
    Item
    known hypersensitivity to decitabine
    boolean
    C0049065 (UMLS CUI [1,1])
    C0020517 (UMLS CUI [1,2])
    hiv
    Item
    known to be hiv-positive
    boolean
    C0019682 (UMLS CUI [1])
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