0 Ratings
ID

13238

Description

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

Link

https://clinicaltrials.gov/show/NCT02040506

Keywords

Versions (1)
  1. 1/25/16 1/25/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 25, 2016

DOI

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License

Creative Commons BY-NC 3.0
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    Eligibility Acute Myelogenous Leukemia NCT02040506

    English

    Eligibility Acute Myelogenous Leukemia NCT02040506

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    relapsed or treatment-refractory aml
    Description

    AML

    Data type

    boolean

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

    ECOG

    Data type

    boolean

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

    life expectancy

    Data type

    boolean

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

    renal and hepatic function

    Data type

    boolean

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

    measurable disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1513041
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    chronic myelogenous leukemia in blast crisis
    Description

    CML

    Data type

    boolean

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

    monoclonal therapy or chemotherapy or radiotherapy

    Data type

    boolean

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

    toxicity

    Data type

    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
    Description

    stem cell transplant and graft-versus-host disease

    Data type

    boolean

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

    allergic or anaphylactic reactions to monoclonal antibody therapy

    Data type

    boolean

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

    cns leukemia

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1332884
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    Similar models

    Eligibility Acute Myelogenous Leukemia NCT02040506

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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