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ID

28335

Descrição

NCT02499003 The GOAL Trial: Rescue Treatment With the Monoclonal Anti CD20-antibody Obinutuzumab (GA101) in Combination With Pixantrone for the Treatment of Patients With Relapsed Aggressive B-cell Lymphoma Source: Prof. Dr. med. Georg Heß Universitätsmedizin Mainz

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Versões (2)
  1. 30/11/2017 30/11/2017 -
  2. 04/01/2018 04/01/2018 -
Titular dos direitos

Prof. Dr. med. Georg Heß

Transferido a

4 de janeiro de 2018

DOI

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Licença

Creative Commons BY-NC 3.0
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    Screening Exclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

    Inglês

    Screening Exclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

    1 Formulários  
    Admininstrative data
    Descrição

    Admininstrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject ID
    Descrição

    Subject ID

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Exclusion criteria
    Descrição

    Exclusion criteria

    Alias
    UMLS CUI-1
    C0680251 (Exclusion Criteria)
    1. Lymphoma other than DLBCL, FL IIIB, transfomed indolent NHL
    Descrição

    Lymphoma other

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0024299 (Lymphoma)
    SNOMED
    115244002
    LOINC
    LA15685-3
    UMLS CUI [1,2]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    2. CNS involvement (brain MRI is required only in cases of clinically suspicious involvement)
    Descrição

    CNS involvement

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0449389 (CNS involvement status)
    SNOMED
    260766009
    3. Pregnant or breastfeeding women
    Descrição

    Pregnancy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    4. Severe concomitant disease
    Descrição

    e.g. uncontrolled arterial hypertension, heart failure (NYHA III-IV), uncontrolled diabetes mellitus, pulmonary fibrosis, uncontrolled hyperlipoproteinaemia

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0243087 (concomitant disease)
    UMLS CUI [1,2]
    C0205082 (Severe (severity modifier))
    SNOMED
    24484000
    LOINC
    LA6750-9
    5. Myocardial infarction within the last 6 months
    Descrição

    Myocardial infarction

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0027051 (Myocardial Infarction)
    SNOMED
    22298006
    6. Active uncontrolled infections incl. HIV-positivity, active Hepatitis B or C
    Descrição

    Hepatitis B Hepatitis C HIV-positive

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0019163 (Hepatitis B)
    SNOMED
    66071002
    LOINC
    LA18126-5
    UMLS CUI [1,2]
    C0019196 (Hepatitis C)
    SNOMED
    50711007
    LOINC
    LA19423-5
    UMLS CUI [1,3]
    C0019682 (HIV)
    SNOMED
    19030005
    LOINC
    LP17126-1
    7. Vaccination with live vaccine within last 4 weeks
    Descrição

    Vaccination

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0042196 (Vaccination)
    SNOMED
    33879002
    LOINC
    LP29692-8
    8. Mental status precluding patient's compliance
    Descrição

    Mental status compliance

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0278060 (Mental state)
    SNOMED
    363871006
    LOINC
    MTHU001424
    UMLS CUI [1,2]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    9. Known CD20 negativity
    Descrição

    CD20 negativity

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0054946 (CD20 Antigens)
    SNOMED
    82753007
    LOINC
    LP14623-0
    UMLS CUI [1,2]
    C0205160 (Negative)
    SNOMED
    260385009
    LOINC
    LP20719-8
    10. Diagnosed or treated for a malignancy other than NHL
    Descrição

    Except: adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the Cervix, DCIS of the breast, or other solid tumors curatively treated with no evidence of disease for >3 years, or prostate cancer with a life expectancy of more than 2 years

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488 (Comorbidity)
    UMLS CUI [1,2]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    11. Treatment with any approved anticancer agent within last 2 weeks
    Descrição

    Any agents must have been stoppped at least 2 weeks prior to day 1 of GOAL treatment and all treatment-related adverse events must have returned to Grade 1.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0920425 (cancer treatment)
    UMLS CUI [1,2]
    C0003392 (Antineoplastic Agents)
    SNOMED
    27867009
    12. Prior exposition to Obinutuzumab or Pixantrone
    Descrição

    therapy Obinutuzumab Pixantrone

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [1,2]
    C2742503 (obinutuzumab)
    SNOMED
    710287009
    UMLS CUI [1,3]
    C0253355 (pixantrone)
    SNOMED
    710295008
    13. History of hypersensitivity to medicinal products with similar chemical structure as the trial medication
    Descrição

    Hypersensitivity Investigational New Drugs

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C0013230 (Investigational New Drugs)
    14. Active participation in other interventional clinical trials during the present clinical trial or within the last 2 weeks prior to treatment initiation
    Descrição

    Concurrent participation in non-treatment studies is not excluded.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)
    15. Medical or psychological conditions that would jeopardize an adequate and orderly completion of the trial.
    Descrição

    Compliance behavior Limited (extensiveness) Comorbidity

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [1,2]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8
    UMLS CUI [1,3]
    C0009488 (Comorbidity)
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    Similar models

    Screening Exclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Admininstrative data
    C1320722 (UMLS CUI-1)
    Subject ID
    Item
    Subject ID
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Exclusion criteria
    C0680251 (UMLS CUI-1)
    Lymphoma other
    Item
    1. Lymphoma other than DLBCL, FL IIIB, transfomed indolent NHL
    boolean
    C0024299 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    CNS involvement
    Item
    2. CNS involvement (brain MRI is required only in cases of clinically suspicious involvement)
    boolean
    C0449389 (UMLS CUI [1])
    Pregnancy
    Item
    3. Pregnant or breastfeeding women
    boolean
    C0032961 (UMLS CUI [1])
    Severe concomitant disease
    Item
    4. Severe concomitant disease
    boolean
    C0243087 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    Myocardial infarction
    Item
    5. Myocardial infarction within the last 6 months
    boolean
    C0027051 (UMLS CUI [1])
    Hepatitis B Hepatitis C HIV-positive
    Item
    6. Active uncontrolled infections incl. HIV-positivity, active Hepatitis B or C
    boolean
    C0019163 (UMLS CUI [1,1])
    C0019196 (UMLS CUI [1,2])
    C0019682 (UMLS CUI [1,3])
    Vaccination
    Item
    7. Vaccination with live vaccine within last 4 weeks
    boolean
    C0042196 (UMLS CUI [1])
    Mental status compliance
    Item
    8. Mental status precluding patient's compliance
    boolean
    C0278060 (UMLS CUI [1,1])
    C1321605 (UMLS CUI [1,2])
    CD20 negativity
    Item
    9. Known CD20 negativity
    boolean
    C0054946 (UMLS CUI [1,1])
    C0205160 (UMLS CUI [1,2])
    comorbidity Malignant Neoplasms
    Item
    10. Diagnosed or treated for a malignancy other than NHL
    boolean
    C0009488 (UMLS CUI [1,1])
    C0006826 (UMLS CUI [1,2])
    Treatment anticancer agent
    Item
    11. Treatment with any approved anticancer agent within last 2 weeks
    boolean
    C0920425 (UMLS CUI [1,1])
    C0003392 (UMLS CUI [1,2])
    therapy Obinutuzumab Pixantrone
    Item
    12. Prior exposition to Obinutuzumab or Pixantrone
    boolean
    C0087111 (UMLS CUI [1,1])
    C2742503 (UMLS CUI [1,2])
    C0253355 (UMLS CUI [1,3])
    Hypersensitivity Investigational New Drugs
    Item
    13. History of hypersensitivity to medicinal products with similar chemical structure as the trial medication
    boolean
    C0020517 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    study subject participation status
    Item
    14. Active participation in other interventional clinical trials during the present clinical trial or within the last 2 weeks prior to treatment initiation
    boolean
    C2348568 (UMLS CUI [1])
    Compliance behavior Limited (extensiveness) Comorbidity
    Item
    15. Medical or psychological conditions that would jeopardize an adequate and orderly completion of the trial.
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [1,3])
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