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ID

27837

Beschrijving

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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Versies (2)
  1. 30-11-17 30-11-17 -
  2. 04-01-18 04-01-18 -
Houder van rechten

Prof. Dr. med. Georg Heß

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30 november 2017

DOI

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Licentie

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

    Engels

    Screening Exclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

    1 Formulieren  
    Admininstrative data
    Beschrijving

    Admininstrative data

    Subject ID
    Beschrijving

    Subject ID

    Datatype

    text

    Exclusion criteria
    Beschrijving

    Exclusion criteria

    1. Lymphoma other than DLBCL, FL IIIB, transfomed indolent NHL
    Beschrijving

    Other lymphoma

    Datatype

    boolean

    2. CNS involvement (brain MRI is required only in cases of clinically suspicious involvement)
    Beschrijving

    CNS involvement

    Datatype

    boolean

    3. Pregnant or breastfeeding women
    Beschrijving

    Pregnancy

    Datatype

    boolean

    4. Severe concomitant disease
    Beschrijving

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

    Datatype

    boolean

    5. Myocardial infarction within the last 6 months
    Beschrijving

    Myocardial infarction within the last 6 months

    Datatype

    boolean

    6. Active uncontrolled infections incl. HIV-positivity, active Hepatitis B or C
    Beschrijving

    Active uncontrolled infections

    Datatype

    boolean

    7. Vaccination with live vaccine within last 4 weeks
    Beschrijving

    Vaccination

    Datatype

    boolean

    8. Mental status precluding patient's compliance
    Beschrijving

    Mental status

    Datatype

    boolean

    9. Known CD20 negativity
    Beschrijving

    CD20 negativity

    Datatype

    boolean

    10. Diagnosed or treated for a malignancy other than NHL
    Beschrijving

    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

    Datatype

    boolean

    11. Treatment with any approved anticancer agent within last 2 weeks
    Beschrijving

    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.

    Datatype

    boolean

    12. Prior exposition to Obinutuzumab or Pixantrone
    Beschrijving

    exposition to Obinutuzumab or Pixantrone

    Datatype

    boolean

    13. History of hypersensitivity to medicinal products with similar chemical structure as the trial medication
    Beschrijving

    hypersensitivity to medicinal products

    Datatype

    boolean

    14. Active participation in other interventional clinical trials during the present clinical trial or within the last 2 weeks prior to treatment initiation
    Beschrijving

    Concurrent participation in non-treatment studies is not excluded.

    Datatype

    boolean

    15. Medical or psychological conditions that would jeopardize an adequate and orderly completion of the trial.
    Beschrijving

    Medical or psychological conditions

    Datatype

    boolean

    Terug naar het begin van de pagina

    Similar models

    Screening Exclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Admininstrative data
    Subject ID
    Item
    Subject ID
    text
    Item Group
    Exclusion criteria
    Other lymphoma
    Item
    1. Lymphoma other than DLBCL, FL IIIB, transfomed indolent NHL
    boolean
    CNS involvement
    Item
    2. CNS involvement (brain MRI is required only in cases of clinically suspicious involvement)
    boolean
    Pregnancy
    Item
    3. Pregnant or breastfeeding women
    boolean
    Severe concomitant disease
    Item
    4. Severe concomitant disease
    boolean
    Myocardial infarction within the last 6 months
    Item
    5. Myocardial infarction within the last 6 months
    boolean
    Active uncontrolled infections
    Item
    6. Active uncontrolled infections incl. HIV-positivity, active Hepatitis B or C
    boolean
    Vaccination
    Item
    7. Vaccination with live vaccine within last 4 weeks
    boolean
    Mental status
    Item
    8. Mental status precluding patient's compliance
    boolean
    CD20 negativity
    Item
    9. Known CD20 negativity
    boolean
    malignancy other than NHL
    Item
    10. Diagnosed or treated for a malignancy other than NHL
    boolean
    Treatment with anticancer agent
    Item
    11. Treatment with any approved anticancer agent within last 2 weeks
    boolean
    exposition to Obinutuzumab or Pixantrone
    Item
    12. Prior exposition to Obinutuzumab or Pixantrone
    boolean
    hypersensitivity to medicinal products
    Item
    13. History of hypersensitivity to medicinal products with similar chemical structure as the trial medication
    boolean
    participation in other interventional clinical trials
    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
    Medical or psychological conditions
    Item
    15. Medical or psychological conditions that would jeopardize an adequate and orderly completion of the trial.
    boolean
    Terug naar het begin van de pagina 

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