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ID

13238

Beskrivning

A Phase I Study of IGN523 in Subjects With Relapsed or Refractory AML; ODM derived from: https://clinicaltrials.gov/show/NCT02040506

Länk

https://clinicaltrials.gov/show/NCT02040506

Nyckelord

  1. 2016-01-25 2016-01-25 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

25 januari 2016

DOI

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Licens

Creative Commons BY-NC 3.0

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    Eligibility Acute Myelogenous Leukemia NCT02040506

    Eligibility Acute Myelogenous Leukemia NCT02040506

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    relapsed or treatment-refractory aml
    Beskrivning

    AML

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023467
    eastern cooperative oncology group status 0-2
    Beskrivning

    ECOG

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    life expectancy of at least 12 weeks
    Beskrivning

    life expectancy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    adequate baseline renal and hepatic function
    Beskrivning

    renal and hepatic function

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0232804
    UMLS CUI [2]
    C0232741
    measurable disease (eg, peripheral blasts greater than 5%)
    Beskrivning

    measurable disease

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1513041
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    chronic myelogenous leukemia in blast crisis
    Beskrivning

    CML

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023474
    monoclonal therapy within 4 weeks, or chemotherapy or radiotherapy within 2 weeks
    Beskrivning

    monoclonal therapy or chemotherapy or radiotherapy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    UMLS CUI [2]
    C1522449
    UMLS CUI [3]
    C0279694
    unresolved acute toxicity from prior anti-cancer therapy
    Beskrivning

    toxicity

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0013221
    prior allogeneic stem cell transplant and active graft-versus-host disease requiring systemic immunosuppressive therapy within 15 days prior to screening
    Beskrivning

    stem cell transplant and graft-versus-host disease

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1504389
    UMLS CUI [2]
    C0018133
    history of severe allergic or anaphylactic reactions to monoclonal antibody therapy
    Beskrivning

    allergic or anaphylactic reactions to monoclonal antibody therapy

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0279694
    known current leptomeningeal or central nervous system (cns) involvement of leukemia
    Beskrivning

    cns leukemia

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1332884

    Similar models

    Eligibility Acute Myelogenous Leukemia NCT02040506

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    AML
    Item
    relapsed or treatment-refractory aml
    boolean
    C0023467 (UMLS CUI [1])
    ECOG
    Item
    eastern cooperative oncology group status 0-2
    boolean
    C1520224 (UMLS CUI [1])
    life expectancy
    Item
    life expectancy of at least 12 weeks
    boolean
    C0023671 (UMLS CUI [1])
    renal and hepatic function
    Item
    adequate baseline renal and hepatic function
    boolean
    C0232804 (UMLS CUI [1])
    C0232741 (UMLS CUI [2])
    measurable disease
    Item
    measurable disease (eg, peripheral blasts greater than 5%)
    boolean
    C1513041 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    CML
    Item
    chronic myelogenous leukemia in blast crisis
    boolean
    C0023474 (UMLS CUI [1])
    monoclonal therapy or chemotherapy or radiotherapy
    Item
    monoclonal therapy within 4 weeks, or chemotherapy or radiotherapy within 2 weeks
    boolean
    C0392920 (UMLS CUI [1])
    C1522449 (UMLS CUI [2])
    C0279694 (UMLS CUI [3])
    toxicity
    Item
    unresolved acute toxicity from prior anti-cancer therapy
    boolean
    C0013221 (UMLS CUI [1])
    stem cell transplant and graft-versus-host disease
    Item
    prior allogeneic stem cell transplant and active graft-versus-host disease requiring systemic immunosuppressive therapy within 15 days prior to screening
    boolean
    C1504389 (UMLS CUI [1])
    C0018133 (UMLS CUI [2])
    allergic or anaphylactic reactions to monoclonal antibody therapy
    Item
    history of severe allergic or anaphylactic reactions to monoclonal antibody therapy
    boolean
    C0020517 (UMLS CUI [1,1])
    C0279694 (UMLS CUI [1,2])
    cns leukemia
    Item
    known current leptomeningeal or central nervous system (cns) involvement of leukemia
    boolean
    C1332884 (UMLS CUI [1])

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