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ID

14023

Description

A Safety and Efficacy Study Using Decitabine, Decitabine/Carboplatin, Decitabine/Arsenic for the Treatment of Relapsed, Refractory, and Elderly Acute Myeloid Leukemia , Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT02190695

Lien

https://clinicaltrials.gov/show/NCT02190695

Mots-clés

  1. 22/03/2016 22/03/2016 -
Téléchargé le

22 mars 2016

DOI

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Licence

Creative Commons BY 4.0

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    Eligibility Acute Myeloid Leukemia NCT02190695

    Eligibility Acute Myeloid Leukemia NCT02190695

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    acute myeloid leukemia, relapsed or refractory and elderly(over 65)
    Description

    Acute myeloid leukemia

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0023467 (Leukemia, Myelocytic, Acute)
    SNOMED
    17788007
    acute myeloid leukemia under 65 but who are unfit for conventional therapy
    Description

    Acute myeloid leukemia

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0023467 (Leukemia, Myelocytic, Acute)
    SNOMED
    17788007
    UMLS CUI [2]
    C3839996 (Patient unsuitable for procedure)
    SNOMED
    702370009
    de novo or treated myelodysplastic syndrome, chronic myelomonocytic leukemia who are int-1or above
    Description

    Myelodysplastic syndrom

    Type de données

    boolean

    Patients may have prior exposure to azacitidine but no decitabine
    Description

    Azacitidine

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0004475 (azacitidine)
    SNOMED
    412329008
    Must be off all chemotherapy for 2 weeks and recovered from any toxicities unless rapidly progressive disease.
    Description

    Chemotherapy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0439577 (Post-chemotherapy)
    SNOMED
    262502001
    Hydrea is permitted for first 4 cycles
    Description

    Hydrea

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0591617 (Hydrea)
    Performance 0-2 (ecog)
    Description

    ECOG performance status

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    Adequate cardiac functions assessed by 2d echo (nyha cardiac iii-iv excluded)
    Description

    Adequate cardiac function

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0438176 (Cardiac function test normal)
    SNOMED
    165075003
    Pretreatment Electrocardiogram
    Description

    Electrocardiogram

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0013798 (Electrocardiogram)
    LOINC
    LP149975-7
    Lab results
    Description

    Lab results

    Type de données

    integer

    Absence of significant intercurrent illness such as uncontrolled heart failure, unstable angina or cardiac arrhythmia
    Description

    Intercurrent illness

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0018801 (Heart failure)
    SNOMED
    84114007
    LOINC
    LP269421-6
    UMLS CUI [2]
    C0002965 (Angina, Unstable)
    SNOMED
    4557003
    Psychiatric illness which precludes the giving of informed consent
    Description

    Psychiatric illness

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0004936 (Mental disorders)
    SNOMED
    74732009
    Informed Consent
    Description

    Informed Consent

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    Nursing and pregnant females
    Description

    Pregnant

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0549206 (Patient currently pregnant)
    SNOMED
    77386006
    LOINC
    LA14670-6
    Current uncontrolled infections
    Description

    uncontrolled infections

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C3714514 (Infection)
    LOINC
    LP130385-0
    Uncontrolled intercurrent illness including , but not limited to the above list
    Description

    Significant Intercurrent Illness

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C3640977 (Significant Intercurrent Illness)
    Chronic kidney disease> stage 3
    Description

    Chronic kidney disease

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0022661 (Kidney Failure, Chronic)
    SNOMED
    46177005
    LOINC
    LP146090-8
    Hiv infection
    Description

    HIV Infections

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0019693 (HIV Infections)
    SNOMED
    86406008

    Similar models

    Eligibility Acute Myeloid Leukemia NCT02190695

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Acute myeloid leukemia
    Item
    acute myeloid leukemia, relapsed or refractory and elderly(over 65)
    boolean
    C0023467 (UMLS CUI [1])
    Acute myeloid leukemia
    Item
    acute myeloid leukemia under 65 but who are unfit for conventional therapy
    boolean
    C0023467 (UMLS CUI [1])
    C3839996 (UMLS CUI [2])
    Myelodysplastic syndrom
    Item
    de novo or treated myelodysplastic syndrome, chronic myelomonocytic leukemia who are int-1or above
    boolean
    Azacitidine
    Item
    Patients may have prior exposure to azacitidine but no decitabine
    boolean
    C0004475 (UMLS CUI [1])
    Chemotherapy
    Item
    Must be off all chemotherapy for 2 weeks and recovered from any toxicities unless rapidly progressive disease.
    boolean
    C0439577 (UMLS CUI [1])
    Hydrea
    Item
    Hydrea is permitted for first 4 cycles
    boolean
    C0591617 (UMLS CUI [1])
    ECOG performance status
    Item
    Performance 0-2 (ecog)
    boolean
    C1520224 (UMLS CUI [1])
    Adequate cardiac function
    Item
    Adequate cardiac functions assessed by 2d echo (nyha cardiac iii-iv excluded)
    boolean
    C0438176 (UMLS CUI [1])
    Electrocardiogram
    Item
    Pretreatment Electrocardiogram
    boolean
    C0013798 (UMLS CUI [1])
    Item
    Lab results
    integer
    Code List
    Lab results
    CL Item
    Creatinine (1)
    C0010294 (UMLS CUI-1)
    CL Item
    Total billirubine (2)
    C0005437 (UMLS CUI-1)
    Intercurrent illness
    Item
    Absence of significant intercurrent illness such as uncontrolled heart failure, unstable angina or cardiac arrhythmia
    boolean
    C0018801 (UMLS CUI [1])
    C0002965 (UMLS CUI [2])
    Psychiatric illness
    Item
    Psychiatric illness which precludes the giving of informed consent
    boolean
    C0004936 (UMLS CUI [1])
    Informed Consent
    Item
    Informed Consent
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Pregnant
    Item
    Nursing and pregnant females
    boolean
    C0549206 (UMLS CUI [1])
    uncontrolled infections
    Item
    Current uncontrolled infections
    boolean
    C3714514 (UMLS CUI [1])
    Significant Intercurrent Illness
    Item
    Uncontrolled intercurrent illness including , but not limited to the above list
    boolean
    C3640977 (UMLS CUI [1])
    Chronic kidney disease
    Item
    Chronic kidney disease> stage 3
    boolean
    C0022661 (UMLS CUI [1])
    HIV Infections
    Item
    Hiv infection
    boolean
    C0019693 (UMLS CUI [1])

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