0 Bedömningar
ID

14023

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02190695

Nyckelord

Versioner (1)
  1. 3/22/16 3/22/16 -
Uppladdad den

March 22, 2016

DOI

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Licens

Creative Commons BY 4.0
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    Eligibility Acute Myeloid Leukemia NCT02190695

    Engelsk

    Eligibility Acute Myeloid Leukemia NCT02190695

    1 Formulär  
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

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

    Acute myeloid leukemia

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023467
    acute myeloid leukemia under 65 but who are unfit for conventional therapy
    Beskrivning

    Acute myeloid leukemia

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023467
    UMLS CUI [2]
    C3839996
    de novo or treated myelodysplastic syndrome, chronic myelomonocytic leukemia who are int-1or above
    Beskrivning

    Myelodysplastic syndrom

    Datatyp

    boolean

    Patients may have prior exposure to azacitidine but no decitabine
    Beskrivning

    Azacitidine

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0004475
    Must be off all chemotherapy for 2 weeks and recovered from any toxicities unless rapidly progressive disease.
    Beskrivning

    Chemotherapy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0439577
    Hydrea is permitted for first 4 cycles
    Beskrivning

    Hydrea

    Datatyp

    boolean

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

    ECOG performance status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    Adequate cardiac functions assessed by 2d echo (nyha cardiac iii-iv excluded)
    Beskrivning

    Adequate cardiac function

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0438176
    Pretreatment Electrocardiogram
    Beskrivning

    Electrocardiogram

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0013798
    Lab results
    Beskrivning

    Lab results

    Datatyp

    integer

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

    Intercurrent illness

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0018801
    UMLS CUI [2]
    C0002965
    Psychiatric illness which precludes the giving of informed consent
    Beskrivning

    Psychiatric illness

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0004936
    Informed Consent
    Beskrivning

    Informed Consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    Nursing and pregnant females
    Beskrivning

    Pregnant

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0549206
    Current uncontrolled infections
    Beskrivning

    uncontrolled infections

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3714514
    Uncontrolled intercurrent illness including , but not limited to the above list
    Beskrivning

    Significant Intercurrent Illness

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3640977
    Chronic kidney disease> stage 3
    Beskrivning

    Chronic kidney disease

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0022661
    Hiv infection
    Beskrivning

    HIV Infections

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0019693
    Tillbaka till toppen

    Similar models

    Eligibility Acute Myeloid Leukemia NCT02190695

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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
    Lab results
    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])
    Tillbaka till toppen 

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