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ID

41230

Description

A Study of Subcutaneous Versus Intravenous MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in Patients With Previously Untreated CD20-Positive Diffuse Large B-Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01649856

Link

https://clinicaltrials.gov/show/NCT01649856

Keywords

Versions (1)
  1. 7/21/20 7/21/20 -
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See clinicaltrials.gov

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July 21, 2020

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License

Creative Commons BY 4.0
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    Eligibility Lymphoma, B-Cell NCT01649856

    English

    Eligibility Lymphoma, B-Cell NCT01649856

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    adult patients, >/= 18 and </= 80 years of age at time of study inclusion
    Description

    Adult | Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001675
    UMLS CUI [2]
    C0001779
    histologically confirmed, previously untreated cd20-positive diffuse large b-cell lymphoma (dlbcl) according to the who classification system
    Description

    Diffuse Large B-Cell Lymphoma CD20 positive Untreated WHO tumor classification

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0079744
    UMLS CUI [1,2]
    C3888518
    UMLS CUI [1,3]
    C0332155
    UMLS CUI [1,4]
    C1301142
    patients with an international prognostic index (ipi) score 1-5, or ipi score 0 with bulky disease, defined as one lesion >/= 7.5 cm
    Description

    International Prognostic Index | Bulky Disease | Lesion Size Quantity

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1512894
    UMLS CUI [2]
    C1511341
    UMLS CUI [3,1]
    C0221198
    UMLS CUI [3,2]
    C0449453
    UMLS CUI [3,3]
    C1265611
    at least one bi-dimensionally measurable lesion defined as >/= 1.5 cm in its largest dimension on ct scan, pet-ct scan or mri
    Description

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

    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
    UMLS CUI [3,1]
    C1275593
    UMLS CUI [3,2]
    C0032743
    UMLS CUI [4,1]
    C1275593
    UMLS CUI [4,2]
    C0024485
    adequate hematologic function
    Description

    Hematologic function

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0221130
    eastern cooperative oncology group (eocd) performance status </= 2
    Description

    ECOG performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    primary or secondary central nervous system lymphoma, histologic evidence of transformation to burkitt lymphoma, primary mediastinal dlbcl, primary effusion lymphoma, primary cutaneous dlbcl, or primary dlbcl of the testis
    Description

    Primary central nervous system lymphoma | Secondary Central Nervous System Lymphoma | Ttransformation Burkitt Lymphoma | Mediastinal (Thymic) Large B-Cell Lymphoma | Primary Effusion Lymphoma | Primary cutaneous diffuse large cell B-cell lymphoma | Large B-cell diffuse lymphoma of testis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0280803
    UMLS CUI [2]
    C2981383
    UMLS CUI [3,1]
    C0040682
    UMLS CUI [3,2]
    C0006413
    UMLS CUI [4]
    C1292754
    UMLS CUI [5]
    C1292753
    UMLS CUI [6]
    C1275325
    UMLS CUI [7]
    C2057634
    transformed lymphoma or follicular lymphoma iiib
    Description

    Transformation Lymphoma | Follicular Lymphoma Ann Arbor lymphoma staging system

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0040682
    UMLS CUI [1,2]
    C0024299
    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
    history of other malignancy, except for curatively treated basal or squamous cell carcinoma or melanoma of the skin, carcinoma in situ of the cervix, or a malignancy that has been treated without curative intent and has been in remission without treatment for >/= 5 years prior to enrolment
    Description

    Cancer Other | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma | Exception Curative treatment Cutaneous Melanoma | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Malignant Neoplasm Remission Duration

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1707251
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C1273390
    UMLS CUI [2,3]
    C0007117
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C1273390
    UMLS CUI [3,3]
    C0007137
    UMLS CUI [4,1]
    C1705847
    UMLS CUI [4,2]
    C1273390
    UMLS CUI [4,3]
    C0151779
    UMLS CUI [5,1]
    C1705847
    UMLS CUI [5,2]
    C1273390
    UMLS CUI [5,3]
    C0851140
    UMLS CUI [6,1]
    C1705847
    UMLS CUI [6,2]
    C0006826
    UMLS CUI [6,3]
    C0687702
    UMLS CUI [6,4]
    C0449238
    inadequate renal or hepatic function
    Description

    Renal function Inadequate | Liver function Inadequate

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0232804
    UMLS CUI [1,2]
    C0205412
    UMLS CUI [2,1]
    C0232741
    UMLS CUI [2,2]
    C0205412
    known human immunodeficiency virus (hiv) infection or hiv seropositive status
    Description

    HIV Infections | HIV Seropositivity

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019693
    UMLS CUI [2]
    C0019699
    active hepatitis b virus (hbv) or active hepatitis c virus (hcv) infection. patients with occult or prior hbv infection as defined by protocol may be included. patients positive for hcv antibody are eligible only if polymerase chain reaction testing for hcv ribonucleic acid is negative.
    Description

    Hepatitis B | Hepatitis C

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019163
    UMLS CUI [2]
    C0019196
    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
    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
    pregnant or lactating women
    Description

    Pregnancy | Breast Feeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
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    Similar models

    Eligibility Lymphoma, B-Cell NCT01649856

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Adult | Age
    Item
    adult patients, >/= 18 and </= 80 years of age at time of study inclusion
    boolean
    C0001675 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    Diffuse Large B-Cell Lymphoma CD20 positive Untreated WHO tumor classification
    Item
    histologically confirmed, previously untreated cd20-positive diffuse large b-cell lymphoma (dlbcl) according to the who classification system
    boolean
    C0079744 (UMLS CUI [1,1])
    C3888518 (UMLS CUI [1,2])
    C0332155 (UMLS CUI [1,3])
    C1301142 (UMLS CUI [1,4])
    International Prognostic Index | Bulky Disease | Lesion Size Quantity
    Item
    patients with an international prognostic index (ipi) score 1-5, or ipi score 0 with bulky disease, defined as one lesion >/= 7.5 cm
    boolean
    C1512894 (UMLS CUI [1])
    C1511341 (UMLS CUI [2])
    C0221198 (UMLS CUI [3,1])
    C0449453 (UMLS CUI [3,2])
    C1265611 (UMLS CUI [3,3])
    Measurable Disease 2-Dimensional Quantity | Lesion size, largest dimension CT | Lesion size, largest dimension PET scan | Lesion size, largest dimension MRI
    Item
    at least one bi-dimensionally measurable lesion defined as >/= 1.5 cm in its largest dimension on ct scan, pet-ct scan or mri
    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])
    C1275593 (UMLS CUI [3,1])
    C0032743 (UMLS CUI [3,2])
    C1275593 (UMLS CUI [4,1])
    C0024485 (UMLS CUI [4,2])
    Hematologic function
    Item
    adequate hematologic function
    boolean
    C0221130 (UMLS CUI [1])
    ECOG performance status
    Item
    eastern cooperative oncology group (eocd) performance status </= 2
    boolean
    C1520224 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Primary central nervous system lymphoma | Secondary Central Nervous System Lymphoma | Ttransformation Burkitt Lymphoma | Mediastinal (Thymic) Large B-Cell Lymphoma | Primary Effusion Lymphoma | Primary cutaneous diffuse large cell B-cell lymphoma | Large B-cell diffuse lymphoma of testis
    Item
    primary or secondary central nervous system lymphoma, histologic evidence of transformation to burkitt lymphoma, primary mediastinal dlbcl, primary effusion lymphoma, primary cutaneous dlbcl, or primary dlbcl of the testis
    boolean
    C0280803 (UMLS CUI [1])
    C2981383 (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])
    C2057634 (UMLS CUI [7])
    Transformation Lymphoma | Follicular Lymphoma Ann Arbor lymphoma staging system
    Item
    transformed lymphoma or follicular lymphoma iiib
    boolean
    C0040682 (UMLS CUI [1,1])
    C0024299 (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])
    Cancer Other | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma | Exception Curative treatment Cutaneous Melanoma | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Malignant Neoplasm Remission Duration
    Item
    history of other malignancy, except for curatively treated basal or squamous cell carcinoma or melanoma of the skin, carcinoma in situ of the cervix, or a malignancy that has been treated without curative intent and has been in remission without treatment for >/= 5 years prior to enrolment
    boolean
    C1707251 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C1273390 (UMLS CUI [2,2])
    C0007117 (UMLS CUI [2,3])
    C1705847 (UMLS CUI [3,1])
    C1273390 (UMLS CUI [3,2])
    C0007137 (UMLS CUI [3,3])
    C1705847 (UMLS CUI [4,1])
    C1273390 (UMLS CUI [4,2])
    C0151779 (UMLS CUI [4,3])
    C1705847 (UMLS CUI [5,1])
    C1273390 (UMLS CUI [5,2])
    C0851140 (UMLS CUI [5,3])
    C1705847 (UMLS CUI [6,1])
    C0006826 (UMLS CUI [6,2])
    C0687702 (UMLS CUI [6,3])
    C0449238 (UMLS CUI [6,4])
    Renal function Inadequate | Liver function Inadequate
    Item
    inadequate renal or hepatic function
    boolean
    C0232804 (UMLS CUI [1,1])
    C0205412 (UMLS CUI [1,2])
    C0232741 (UMLS CUI [2,1])
    C0205412 (UMLS CUI [2,2])
    HIV Infections | HIV Seropositivity
    Item
    known human immunodeficiency virus (hiv) infection or hiv seropositive status
    boolean
    C0019693 (UMLS CUI [1])
    C0019699 (UMLS CUI [2])
    Hepatitis B | Hepatitis C
    Item
    active hepatitis b virus (hbv) or active hepatitis c virus (hcv) infection. patients with occult or prior hbv infection as defined by protocol may be included. patients positive for hcv antibody are eligible only if polymerase chain reaction testing for hcv ribonucleic acid is negative.
    boolean
    C0019163 (UMLS CUI [1])
    C0019196 (UMLS CUI [2])
    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])
    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])
    Pregnancy | Breast Feeding
    Item
    pregnant or lactating women
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
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