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ID

13238

Description

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

Lien

https://clinicaltrials.gov/show/NCT02040506

Mots-clés

Versions (1)
  1. 25/01/2016 25/01/2016 -
Détendeur de droits

CC BY-NC 3.0

Téléchargé le

25 janvier 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
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    Eligibility Acute Myelogenous Leukemia NCT02040506

    Anglais

    Eligibility Acute Myelogenous Leukemia NCT02040506

    1 Formulaires  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    relapsed or treatment-refractory aml
    Description

    AML

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0023467 (Leukemia, Myelocytic, Acute)
    SNOMED
    17788007
    eastern cooperative oncology group status 0-2
    Description

    ECOG

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    life expectancy of at least 12 weeks
    Description

    life expectancy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0023671 (Life Expectancy)
    adequate baseline renal and hepatic function
    Description

    renal and hepatic function

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0232804 (Renal function)
    SNOMED
    11953005
    LOINC
    LP31398-8
    UMLS CUI [2]
    C0232741 (Liver function)
    SNOMED
    79036002
    LOINC
    LP31397-0
    measurable disease (eg, peripheral blasts greater than 5%)
    Description

    measurable disease

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1513041 (Measurable Disease)
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    chronic myelogenous leukemia in blast crisis
    Description

    CML

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0023474 (Leukemia, Myeloid, Chronic-Phase)
    SNOMED
    413847001
    monoclonal therapy within 4 weeks, or chemotherapy or radiotherapy within 2 weeks
    Description

    monoclonal therapy or chemotherapy or radiotherapy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    UMLS CUI [2]
    C1522449 (Therapeutic radiology procedure)
    SNOMED
    53438000
    LOINC
    LA4351-8
    UMLS CUI [3]
    C0279694 (Monoclonal Antibody Therapy)
    unresolved acute toxicity from prior anti-cancer therapy
    Description

    toxicity

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0013221 (Drug toxicity)
    SNOMED
    7895008
    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

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1504389 (Stem cell transplant)
    UMLS CUI [2]
    C0018133 (Graft-vs-Host Disease)
    SNOMED
    234646005
    history of severe allergic or anaphylactic reactions to monoclonal antibody therapy
    Description

    allergic or anaphylactic reactions to monoclonal antibody therapy

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C0279694 (Monoclonal Antibody Therapy)
    known current leptomeningeal or central nervous system (cns) involvement of leukemia
    Description

    cns leukemia

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1332884 (Central nervous system leukaemia)
    Retour au début de la page

    Similar models

    Eligibility Acute Myelogenous Leukemia NCT02040506

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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])
    Retour au début de la page 

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