0 Ratings
ID

41220

Description

A Study of Obinutuzumab (RO5072759) in Combination With CHOP Chemotherapy Versus MabThera/Rituxan (Rituximab) With CHOP in Patients With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA); ODM derived from: https://clinicaltrials.gov/show/NCT01287741

Link

https://clinicaltrials.gov/show/NCT01287741

Keywords

Versions (1)
  1. 7/20/20 7/20/20 -
Copyright Holder

See clinicaltrials.gov

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July 20, 2020

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License

Creative Commons BY 4.0
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    Eligibility Lymphoma, B-Cell NCT01287741

    English

    Eligibility Lymphoma, B-Cell NCT01287741

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    adult patients, >/= 18 years of age
    Description

    Adult | Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001675
    UMLS CUI [2]
    C0001779
    previously untreated cd20-positive diffuse large b-cell lymphoma (dlbcl)
    Description

    Diffuse Large B-Cell Lymphoma CD20 positive Untreated

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0079744
    UMLS CUI [1,2]
    C3888518
    UMLS CUI [1,3]
    C0332155
    at least 1 bi-dimensionally measurable lesion (>1.5 cm in is largest dimension on the ct scan)
    Description

    Measurable Disease 2-Dimensional Quantity | Lesion size, largest dimension CT scan

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1513041
    UMLS CUI [1,2]
    C1705052
    UMLS CUI [1,3]
    C1265611
    UMLS CUI [2,1]
    C1275593
    UMLS CUI [2,2]
    C0040405
    eastern cooperative oncology group (ecog) performance status 0, 1 or 2
    Description

    ECOG performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    adequate hematological function
    Description

    Hematologic function

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0221130
    low-intermediate, intermediate or high-risk ipi score (low-risk ipi score: ipi 1 irrespective of bulky disease or ipi 0 with bulky disease, defined as one lesion >/= 7.5 cm)
    Description

    International Prognostic Index Low-Intermediate Risk Group | Risk Intermediate International Prognostic Index | High risk International Prognostic Index | Bulky Disease | Lesion size Quantity

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C5206109
    UMLS CUI [2,1]
    C0035647
    UMLS CUI [2,2]
    C0205103
    UMLS CUI [2,3]
    C1512894
    UMLS CUI [3,1]
    C4319571
    UMLS CUI [3,2]
    C1512894
    UMLS CUI [4]
    C1511341
    UMLS CUI [5,1]
    C0449453
    UMLS CUI [5,2]
    C1265611
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
    Description

    Allergic Reaction Severe Humanized Monoclonal Antibodies | Anaphylaxis Severe Humanized Monoclonal Antibodies | Allergic Reaction Severe Monoclonal Antibodies Murine | Anaphylaxis Severe Monoclonal Antibodies Murine | Hypersensitivity Product Murine

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1527304
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [1,3]
    C2985546
    UMLS CUI [2,1]
    C0002792
    UMLS CUI [2,2]
    C0205082
    UMLS CUI [2,3]
    C2985546
    UMLS CUI [3,1]
    C1527304
    UMLS CUI [3,2]
    C0205082
    UMLS CUI [3,3]
    C0003250
    UMLS CUI [3,4]
    C0026809
    UMLS CUI [4,1]
    C0002792
    UMLS CUI [4,2]
    C0205082
    UMLS CUI [4,3]
    C0003250
    UMLS CUI [4,4]
    C0026809
    UMLS CUI [5,1]
    C0020517
    UMLS CUI [5,2]
    C1254351
    UMLS CUI [5,3]
    C0026809
    contraindication to any of the individual components of chop, including prior receipt of anthracyclines
    Description

    Medical contraindication Component CHOP regimen | Medical contraindication Anthracyclines

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1301624
    UMLS CUI [1,2]
    C1705248
    UMLS CUI [1,3]
    C0163868
    UMLS CUI [2,1]
    C1301624
    UMLS CUI [2,2]
    C0282564
    patients with transformed lymphoma and patients with follicular lymphoma iiib
    Description

    Lymphoma Transformation | Follicular Lymphoma Ann Arbor lymphoma staging system

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0024299
    UMLS CUI [1,2]
    C0040682
    UMLS CUI [2,1]
    C0024301
    UMLS CUI [2,2]
    C0432516
    prior therapy for dlbcl, with the exception of nodal biopsy or local irradiation
    Description

    Prior Therapy Diffuse Large B-Cell Lymphoma | Exception Biopsy of lymph node | Exception Therapeutic radiology procedure Local

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463
    UMLS CUI [1,2]
    C0079744
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0193842
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C1522449
    UMLS CUI [3,3]
    C0205276
    prior treatment with cytotoxic drugs or rituximab for another condition (e.g., rheumatoid arthritis) or prior use of an anti-cd20 antibody
    Description

    Cytotoxic agent | rituximab | Anti-CD20 Antibody

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0304497
    UMLS CUI [2]
    C0393022
    UMLS CUI [3]
    C3891557
    prior use of any monoclonal antibody within 3 months of the start of cycle 1
    Description

    Monoclonal Antibodies

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0003250
    ongoing corticosteroid use of > 30 mg/day of prednisone or equivalent
    Description

    Steroid therapy | Prednisone U/day | Equivalent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0149783
    UMLS CUI [2,1]
    C0032952
    UMLS CUI [2,2]
    C0456683
    UMLS CUI [3]
    C0205163
    primary cns lymphoma, blastic variant of mantle-cell lymphoma, or histologic evidence of transformation to a burkitt lymphoma, primary mediastinal dlbcl, primary effusion lymphoma, and primary cutaneous dlbcl
    Description

    Primary central nervous system lymphoma | Mantle-cell lymphoma | Transformation Burkitt Lymphoma | Mediastinal (Thymic) Large B-Cell Lymphoma | Primary Effusion Lymphoma | Primary cutaneous diffuse large cell B-cell lymphoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0280803
    UMLS CUI [2]
    C0334634
    UMLS CUI [3,1]
    C0040682
    UMLS CUI [3,2]
    C0006413
    UMLS CUI [4]
    C1292754
    UMLS CUI [5]
    C1292753
    UMLS CUI [6]
    C1275325
    positive for hiv
    Description

    HIV Seropositivity

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019699
    active hepatitis b or c infection
    Description

    Hepatitis B | Hepatitis C

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019163
    UMLS CUI [2]
    C0019196
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    Similar models

    Eligibility Lymphoma, B-Cell NCT01287741

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Adult | Age
    Item
    adult patients, >/= 18 years of age
    boolean
    C0001675 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    Diffuse Large B-Cell Lymphoma CD20 positive Untreated
    Item
    previously untreated cd20-positive diffuse large b-cell lymphoma (dlbcl)
    boolean
    C0079744 (UMLS CUI [1,1])
    C3888518 (UMLS CUI [1,2])
    C0332155 (UMLS CUI [1,3])
    Measurable Disease 2-Dimensional Quantity | Lesion size, largest dimension CT scan
    Item
    at least 1 bi-dimensionally measurable lesion (>1.5 cm in is largest dimension on the ct scan)
    boolean
    C1513041 (UMLS CUI [1,1])
    C1705052 (UMLS CUI [1,2])
    C1265611 (UMLS CUI [1,3])
    C1275593 (UMLS CUI [2,1])
    C0040405 (UMLS CUI [2,2])
    ECOG performance status
    Item
    eastern cooperative oncology group (ecog) performance status 0, 1 or 2
    boolean
    C1520224 (UMLS CUI [1])
    Hematologic function
    Item
    adequate hematological function
    boolean
    C0221130 (UMLS CUI [1])
    International Prognostic Index Low-Intermediate Risk Group | Risk Intermediate International Prognostic Index | High risk International Prognostic Index | Bulky Disease | Lesion size Quantity
    Item
    low-intermediate, intermediate or high-risk ipi score (low-risk ipi score: ipi 1 irrespective of bulky disease or ipi 0 with bulky disease, defined as one lesion >/= 7.5 cm)
    boolean
    C5206109 (UMLS CUI [1])
    C0035647 (UMLS CUI [2,1])
    C0205103 (UMLS CUI [2,2])
    C1512894 (UMLS CUI [2,3])
    C4319571 (UMLS CUI [3,1])
    C1512894 (UMLS CUI [3,2])
    C1511341 (UMLS CUI [4])
    C0449453 (UMLS CUI [5,1])
    C1265611 (UMLS CUI [5,2])
    Item Group
    C0680251 (UMLS CUI)
    Allergic Reaction Severe Humanized Monoclonal Antibodies | Anaphylaxis Severe Humanized Monoclonal Antibodies | Allergic Reaction Severe Monoclonal Antibodies Murine | Anaphylaxis Severe Monoclonal Antibodies Murine | Hypersensitivity Product Murine
    Item
    history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
    boolean
    C1527304 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C2985546 (UMLS CUI [1,3])
    C0002792 (UMLS CUI [2,1])
    C0205082 (UMLS CUI [2,2])
    C2985546 (UMLS CUI [2,3])
    C1527304 (UMLS CUI [3,1])
    C0205082 (UMLS CUI [3,2])
    C0003250 (UMLS CUI [3,3])
    C0026809 (UMLS CUI [3,4])
    C0002792 (UMLS CUI [4,1])
    C0205082 (UMLS CUI [4,2])
    C0003250 (UMLS CUI [4,3])
    C0026809 (UMLS CUI [4,4])
    C0020517 (UMLS CUI [5,1])
    C1254351 (UMLS CUI [5,2])
    C0026809 (UMLS CUI [5,3])
    Medical contraindication Component CHOP regimen | Medical contraindication Anthracyclines
    Item
    contraindication to any of the individual components of chop, including prior receipt of anthracyclines
    boolean
    C1301624 (UMLS CUI [1,1])
    C1705248 (UMLS CUI [1,2])
    C0163868 (UMLS CUI [1,3])
    C1301624 (UMLS CUI [2,1])
    C0282564 (UMLS CUI [2,2])
    Lymphoma Transformation | Follicular Lymphoma Ann Arbor lymphoma staging system
    Item
    patients with transformed lymphoma and patients with follicular lymphoma iiib
    boolean
    C0024299 (UMLS CUI [1,1])
    C0040682 (UMLS CUI [1,2])
    C0024301 (UMLS CUI [2,1])
    C0432516 (UMLS CUI [2,2])
    Prior Therapy Diffuse Large B-Cell Lymphoma | Exception Biopsy of lymph node | Exception Therapeutic radiology procedure Local
    Item
    prior therapy for dlbcl, with the exception of nodal biopsy or local irradiation
    boolean
    C1514463 (UMLS CUI [1,1])
    C0079744 (UMLS CUI [1,2])
    C1705847 (UMLS CUI [2,1])
    C0193842 (UMLS CUI [2,2])
    C1705847 (UMLS CUI [3,1])
    C1522449 (UMLS CUI [3,2])
    C0205276 (UMLS CUI [3,3])
    Cytotoxic agent | rituximab | Anti-CD20 Antibody
    Item
    prior treatment with cytotoxic drugs or rituximab for another condition (e.g., rheumatoid arthritis) or prior use of an anti-cd20 antibody
    boolean
    C0304497 (UMLS CUI [1])
    C0393022 (UMLS CUI [2])
    C3891557 (UMLS CUI [3])
    Monoclonal Antibodies
    Item
    prior use of any monoclonal antibody within 3 months of the start of cycle 1
    boolean
    C0003250 (UMLS CUI [1])
    Steroid therapy | Prednisone U/day | Equivalent
    Item
    ongoing corticosteroid use of > 30 mg/day of prednisone or equivalent
    boolean
    C0149783 (UMLS CUI [1])
    C0032952 (UMLS CUI [2,1])
    C0456683 (UMLS CUI [2,2])
    C0205163 (UMLS CUI [3])
    Primary central nervous system lymphoma | Mantle-cell lymphoma | Transformation Burkitt Lymphoma | Mediastinal (Thymic) Large B-Cell Lymphoma | Primary Effusion Lymphoma | Primary cutaneous diffuse large cell B-cell lymphoma
    Item
    primary cns lymphoma, blastic variant of mantle-cell lymphoma, or histologic evidence of transformation to a burkitt lymphoma, primary mediastinal dlbcl, primary effusion lymphoma, and primary cutaneous dlbcl
    boolean
    C0280803 (UMLS CUI [1])
    C0334634 (UMLS CUI [2])
    C0040682 (UMLS CUI [3,1])
    C0006413 (UMLS CUI [3,2])
    C1292754 (UMLS CUI [4])
    C1292753 (UMLS CUI [5])
    C1275325 (UMLS CUI [6])
    HIV Seropositivity
    Item
    positive for hiv
    boolean
    C0019699 (UMLS CUI [1])
    Hepatitis B | Hepatitis C
    Item
    active hepatitis b or c infection
    boolean
    C0019163 (UMLS CUI [1])
    C0019196 (UMLS CUI [2])
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