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ID

28334

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

    English

    Screening Inclusion 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
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI-1
    C1512693
    1. Patients aged >=18 years
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    Trial Protocol Version 1.0: 2. CD20 positive disease
    Description

    Trial Protocol Version 2.0: Criterion 2 removed.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C3888518
    3. Histologically proven diagnosis of diffuse large cell B-cell lymphoma, follicular lymphoma IIIB or transformed indolent lymphoma according to the World Health Organization classification (central pathology review)
    Description

    Diagnosis lymphoma

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0011900
    UMLS CUI [1,2]
    C0024299
    4. Relapsed disease
    Description

    Relapsed disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0277556
    5. ECOG performance status =< 2, unless tumor associated
    Description

    ECOG performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    Trial protocol version 1.0: 6. LVEF >= 45% and normal serum troponin
    Description

    LVEF

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0428772
    Trial protocol Version 2.0: 6. Adequate cardiac reserve
    Description

    Serum troponin level must be consistent with no significant acute or chronic myocardial damage and there should be no evidence of symptomatic disease

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0232164
    UMLS CUI [1,2]
    C2347957
    7. No curative option available
    Description

    cure no

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1880198
    UMLS CUI [1,2]
    C1298908
    8. At least 1 measurable tumor mass (>1.5 cm x >1.0 cm) or bone marrow infiltration
    Description

    tumor mass

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3273930
    9. Signed informed consent
    Description

    informed consent signed

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0742766
    10. Adequate bone marrow reserve / hepatic and renal function
    Description

    Adequate bone marrow reserve: - Platelets of at least 100.000/μl (in case of extensive BM-Infiltration 75.000/μl may be acceptable after discussion with the coordinating investigator); - absolute neutrophil count of at least 1000/μl . Adequate hepatic and renal function: - ALT < 2.5 x upper limit of normal (ULN); - AST < 2.5 x ULN; - total Bilirubin < 1.5 x ULN.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005953
    UMLS CUI [1,2]
    C2347957
    UMLS CUI [1,3]
    C0232741
    UMLS CUI [1,4]
    C0232804
    11. No active Hepatitis B or C or HIV-infection
    Description

    Hepatitis B Hepatitis C HIV-infection

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0019163
    UMLS CUI [1,2]
    C0019196
    UMLS CUI [1,3]
    C0019693
    12. Measured or calculated creatinine clearance > 30 ml/min
    Description

    creatinine clearance

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0812399
    13. Fresh tumor biopsy or archived tissue available
    Description

    Fresh tumor biopsy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0475358
    UMLS CUI [1,2]
    C0005558
    UMLS CUI [1,3]
    C2827486
    14. Ability of patient to understand nature, importance and individual consequences of clinical trial
    Description

    compliance

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1321605
    15. Women post-menopausal for more than two years can participate in the trial. Women with childbearing potential can only participate, if they are surgically sterile or a negative pregnancy test (Serum or Urine) is available before trial and they are willing to practice a highly effective and medically accepted contraception method during trial and for a period of 18 months post-treatment.
    Description

    Reliable contraception comprises systematic contraceptives (oral, implant, injection) or diaphragm / condoms /intrauterine devices (IUP) with spermicide.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0700589
    UMLS CUI [1,3]
    C0232970
    16. Male patients are advised to use contraceptive methods (preferably barrier) during treatment and for a period of 6 months post-treatment
    Description

    contraception male patients

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0086580
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    Similar models

    Screening Inclusion 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
    Inclusion Criteria
    C1512693 (UMLS CUI-1)
    Age
    Item
    1. Patients aged >=18 years
    boolean
    C0001779 (UMLS CUI [1])
    disease CD20 positive
    Item
    Trial Protocol Version 1.0: 2. CD20 positive disease
    boolean
    C0012634 (UMLS CUI [1,1])
    C3888518 (UMLS CUI [1,2])
    Diagnosis lymphoma
    Item
    3. Histologically proven diagnosis of diffuse large cell B-cell lymphoma, follicular lymphoma IIIB or transformed indolent lymphoma according to the World Health Organization classification (central pathology review)
    boolean
    C0011900 (UMLS CUI [1,1])
    C0024299 (UMLS CUI [1,2])
    Relapsed disease
    Item
    4. Relapsed disease
    boolean
    C0277556 (UMLS CUI [1])
    ECOG performance status
    Item
    5. ECOG performance status =< 2, unless tumor associated
    boolean
    C1520224 (UMLS CUI [1])
    LVEF
    Item
    Trial protocol version 1.0: 6. LVEF >= 45% and normal serum troponin
    boolean
    C0428772 (UMLS CUI [1])
    cardiac reserve
    Item
    Trial protocol Version 2.0: 6. Adequate cardiac reserve
    boolean
    C0232164 (UMLS CUI [1,1])
    C2347957 (UMLS CUI [1,2])
    cure no
    Item
    7. No curative option available
    boolean
    C1880198 (UMLS CUI [1,1])
    C1298908 (UMLS CUI [1,2])
    tumor mass
    Item
    8. At least 1 measurable tumor mass (>1.5 cm x >1.0 cm) or bone marrow infiltration
    boolean
    C3273930 (UMLS CUI [1])
    informed consent signed
    Item
    9. Signed informed consent
    boolean
    C0742766 (UMLS CUI [1])
    bone marrow hepatic and renal function
    Item
    10. Adequate bone marrow reserve / hepatic and renal function
    boolean
    C0005953 (UMLS CUI [1,1])
    C2347957 (UMLS CUI [1,2])
    C0232741 (UMLS CUI [1,3])
    C0232804 (UMLS CUI [1,4])
    Hepatitis B Hepatitis C HIV-infection
    Item
    11. No active Hepatitis B or C or HIV-infection
    boolean
    C0019163 (UMLS CUI [1,1])
    C0019196 (UMLS CUI [1,2])
    C0019693 (UMLS CUI [1,3])
    creatinine clearance
    Item
    12. Measured or calculated creatinine clearance > 30 ml/min
    boolean
    C0812399 (UMLS CUI [1])
    Fresh tumor biopsy
    Item
    13. Fresh tumor biopsy or archived tissue available
    boolean
    C0475358 (UMLS CUI [1,1])
    C0005558 (UMLS CUI [1,2])
    C2827486 (UMLS CUI [1,3])
    compliance
    Item
    14. Ability of patient to understand nature, importance and individual consequences of clinical trial
    boolean
    C1321605 (UMLS CUI [1])
    childbearing potential post-menopausal
    Item
    15. Women post-menopausal for more than two years can participate in the trial. Women with childbearing potential can only participate, if they are surgically sterile or a negative pregnancy test (Serum or Urine) is available before trial and they are willing to practice a highly effective and medically accepted contraception method during trial and for a period of 18 months post-treatment.
    boolean
    C3831118 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    C0232970 (UMLS CUI [1,3])
    contraception male patients
    Item
    16. Male patients are advised to use contraceptive methods (preferably barrier) during treatment and for a period of 6 months post-treatment
    boolean
    C0086580 (UMLS CUI [1])
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