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ID

28335

Description

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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Versions (2)
  1. 11/30/17 11/30/17 -
  2. 1/4/18 1/4/18 -
Copyright Holder

Prof. Dr. med. Georg Heß

Uploaded on

January 4, 2018

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License

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

    English

    Screening Exclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

    1 forms  
    Admininstrative data
    Description

    Admininstrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject ID
    Description

    Subject ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Exclusion criteria
    Description

    Exclusion criteria

    Alias
    UMLS CUI-1
    C0680251
    1. Lymphoma other than DLBCL, FL IIIB, transfomed indolent NHL
    Description

    Lymphoma other

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0024299
    UMLS CUI [1,2]
    C0205394
    2. CNS involvement (brain MRI is required only in cases of clinically suspicious involvement)
    Description

    CNS involvement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0449389
    3. Pregnant or breastfeeding women
    Description

    Pregnancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    4. Severe concomitant disease
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0243087
    UMLS CUI [1,2]
    C0205082
    5. Myocardial infarction within the last 6 months
    Description

    Myocardial infarction

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0027051
    6. Active uncontrolled infections incl. HIV-positivity, active Hepatitis B or C
    Description

    Hepatitis B Hepatitis C HIV-positive

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0019163
    UMLS CUI [1,2]
    C0019196
    UMLS CUI [1,3]
    C0019682
    7. Vaccination with live vaccine within last 4 weeks
    Description

    Vaccination

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0042196
    8. Mental status precluding patient's compliance
    Description

    Mental status compliance

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0278060
    UMLS CUI [1,2]
    C1321605
    9. Known CD20 negativity
    Description

    CD20 negativity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0054946
    UMLS CUI [1,2]
    C0205160
    10. Diagnosed or treated for a malignancy other than NHL
    Description

    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

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0006826
    11. Treatment with any approved anticancer agent within last 2 weeks
    Description

    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.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0920425
    UMLS CUI [1,2]
    C0003392
    12. Prior exposition to Obinutuzumab or Pixantrone
    Description

    therapy Obinutuzumab Pixantrone

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C2742503
    UMLS CUI [1,3]
    C0253355
    13. History of hypersensitivity to medicinal products with similar chemical structure as the trial medication
    Description

    Hypersensitivity Investigational New Drugs

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0013230
    14. Active participation in other interventional clinical trials during the present clinical trial or within the last 2 weeks prior to treatment initiation
    Description

    Concurrent participation in non-treatment studies is not excluded.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    15. Medical or psychological conditions that would jeopardize an adequate and orderly completion of the trial.
    Description

    Compliance behavior Limited (extensiveness) Comorbidity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0439801
    UMLS CUI [1,3]
    C0009488
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    Similar models

    Screening Exclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

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