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ID

30424

Descrizione

Aflibercept and Standard Chemotherapy (R-CHOP) in First Line of Non Hodgkin B-cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00644124

collegamento

https://clinicaltrials.gov/show/NCT00644124

Keywords

versioni (1)
  1. 04/06/18 04/06/18 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

4 giugno 2018

DOI

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Licenza

Creative Commons BY 4.0
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    Eligibility Lymphoma, Non-Hodgkin NCT00644124

    Inglese

    Eligibility Lymphoma, Non-Hodgkin NCT00644124

    1 moduli  
    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    patients with non-hodgkin b-cell lymphoma, good condition, not previously treated
    Descrizione

    B-Cell Lymphomas | Patient condition is good | Prior Therapy Absent

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0079731
    UMLS CUI [2]
    C2051434
    UMLS CUI [3,1]
    C1514463
    UMLS CUI [3,2]
    C0332197
    Exclusion Criteria
    Descrizione

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    contraindication to any drug contained in the r-chop (rituximab/cyclophosphamide/doxorubicin/vincristine/prednisone +/- intrathecal methotrexate)
    Descrizione

    Medical contraindication R-CHOP | Medical contraindication Rituximab | Medical contraindication Cyclophosphamide | Medical contraindication Doxorubicin | Medical contraindication Vincristine | Medical contraindication Prednisone | Medical contraindication Methotrexate Intrathecal

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1301624
    UMLS CUI [1,2]
    C0393023
    UMLS CUI [2,1]
    C1301624
    UMLS CUI [2,2]
    C0393022
    UMLS CUI [3,1]
    C1301624
    UMLS CUI [3,2]
    C0010583
    UMLS CUI [4,1]
    C1301624
    UMLS CUI [4,2]
    C0013089
    UMLS CUI [5,1]
    C1301624
    UMLS CUI [5,2]
    C0042679
    UMLS CUI [6,1]
    C1301624
    UMLS CUI [6,2]
    C0032952
    UMLS CUI [7,1]
    C1301624
    UMLS CUI [7,2]
    C0025677
    UMLS CUI [7,3]
    C0677897
    less than 42 days elapsed from prior major surgery (28 days from other prior surgery) to the time of inclusion
    Descrizione

    Major surgery

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0679637
    cerebral or leptomeningeal involvement.
    Descrizione

    Involvement cerebral | Involvement Leptomeningeal

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1314939
    UMLS CUI [1,2]
    C0006104
    UMLS CUI [2,1]
    C1314939
    UMLS CUI [2,2]
    C0521401
    history of another neoplasm (adequately treated basal cell or squamous cell skin cancers, carcinoma in situ of the cervix, or any other cancer from which the patient has been disease free for > 5 years are allowed)
    Descrizione

    Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Malignant Neoplasms Disease Free of

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1707251
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0007117
    UMLS CUI [2,3]
    C1522326
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0553723
    UMLS CUI [3,3]
    C1522326
    UMLS CUI [4,1]
    C1705847
    UMLS CUI [4,2]
    C0851140
    UMLS CUI [4,3]
    C1522326
    UMLS CUI [5,1]
    C1705847
    UMLS CUI [5,2]
    C0006826
    UMLS CUI [5,3]
    C0012634
    UMLS CUI [5,4]
    C0332296
    participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to the first drug intake
    Descrizione

    Study Subject Participation Status | Therapies, Investigational | Investigational New Drugs

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    UMLS CUI [2]
    C0949266
    UMLS CUI [3]
    C0013230
    any acute or chronic medical condition, which could impair the ability of the patient to participate to the study or could interfere with interpretation of study results
    Descrizione

    Medical condition Impairing Study Subject Participation Status | Medical condition chronic Impairing Study Subject Participation Status | Medical condition Interferes with Interpretation Research results | Medical condition chronic Interferes with Interpretation Research results

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040
    UMLS CUI [1,2]
    C0221099
    UMLS CUI [1,3]
    C2348568
    UMLS CUI [2,1]
    C3843040
    UMLS CUI [2,2]
    C0205191
    UMLS CUI [2,3]
    C0221099
    UMLS CUI [2,4]
    C2348568
    UMLS CUI [3,1]
    C3843040
    UMLS CUI [3,2]
    C0521102
    UMLS CUI [3,3]
    C0459471
    UMLS CUI [3,4]
    C0683954
    UMLS CUI [4,1]
    C3843040
    UMLS CUI [4,2]
    C0205191
    UMLS CUI [4,3]
    C0521102
    UMLS CUI [4,4]
    C0459471
    UMLS CUI [4,5]
    C0683954
    uncontrolled diabetes mellitus
    Descrizione

    Diabetic - poor control

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0421258
    uncontrolled hypertension
    Descrizione

    Uncontrolled hypertension

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1868885
    abnormal kidney function
    Descrizione

    Abnormal renal function

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0151746
    evidence of clinically significant bleeding diathesis, non-healing wound or underlying coagulopathy
    Descrizione

    Bleeding tendency | Wound, non-healing | Blood Coagulation Disorder

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1458140
    UMLS CUI [2]
    C0750433
    UMLS CUI [3]
    C0005779
    pregnant or breast-feeding woman, or patient with reproductive potential (male, female) without an effective method of contraception
    Descrizione

    Pregnancy | Breast Feeding | Females & males of reproductive potential Contraceptive methods Absent

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3,1]
    C4034483
    UMLS CUI [3,2]
    C0700589
    UMLS CUI [3,3]
    C0332197
    history of hypersensitivity to any trap agents or recombinant proteins
    Descrizione

    Hypersensitivity TRAP | Hypersensitivity Recombinant Proteins

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0297331
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0034861
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    Similar models

    Eligibility Lymphoma, Non-Hodgkin NCT00644124

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    C1512693 (UMLS CUI)
    B-Cell Lymphomas | Patient condition is good | Prior Therapy Absent
    Item
    patients with non-hodgkin b-cell lymphoma, good condition, not previously treated
    boolean
    C0079731 (UMLS CUI [1])
    C2051434 (UMLS CUI [2])
    C1514463 (UMLS CUI [3,1])
    C0332197 (UMLS CUI [3,2])
    Item Group
    C0680251 (UMLS CUI)
    Medical contraindication R-CHOP | Medical contraindication Rituximab | Medical contraindication Cyclophosphamide | Medical contraindication Doxorubicin | Medical contraindication Vincristine | Medical contraindication Prednisone | Medical contraindication Methotrexate Intrathecal
    Item
    contraindication to any drug contained in the r-chop (rituximab/cyclophosphamide/doxorubicin/vincristine/prednisone +/- intrathecal methotrexate)
    boolean
    C1301624 (UMLS CUI [1,1])
    C0393023 (UMLS CUI [1,2])
    C1301624 (UMLS CUI [2,1])
    C0393022 (UMLS CUI [2,2])
    C1301624 (UMLS CUI [3,1])
    C0010583 (UMLS CUI [3,2])
    C1301624 (UMLS CUI [4,1])
    C0013089 (UMLS CUI [4,2])
    C1301624 (UMLS CUI [5,1])
    C0042679 (UMLS CUI [5,2])
    C1301624 (UMLS CUI [6,1])
    C0032952 (UMLS CUI [6,2])
    C1301624 (UMLS CUI [7,1])
    C0025677 (UMLS CUI [7,2])
    C0677897 (UMLS CUI [7,3])
    Major surgery
    Item
    less than 42 days elapsed from prior major surgery (28 days from other prior surgery) to the time of inclusion
    boolean
    C0679637 (UMLS CUI [1])
    Involvement cerebral | Involvement Leptomeningeal
    Item
    cerebral or leptomeningeal involvement.
    boolean
    C1314939 (UMLS CUI [1,1])
    C0006104 (UMLS CUI [1,2])
    C1314939 (UMLS CUI [2,1])
    C0521401 (UMLS CUI [2,2])
    Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Malignant Neoplasms Disease Free of
    Item
    history of another neoplasm (adequately treated basal cell or squamous cell skin cancers, carcinoma in situ of the cervix, or any other cancer from which the patient has been disease free for > 5 years are allowed)
    boolean
    C1707251 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0007117 (UMLS CUI [2,2])
    C1522326 (UMLS CUI [2,3])
    C1705847 (UMLS CUI [3,1])
    C0553723 (UMLS CUI [3,2])
    C1522326 (UMLS CUI [3,3])
    C1705847 (UMLS CUI [4,1])
    C0851140 (UMLS CUI [4,2])
    C1522326 (UMLS CUI [4,3])
    C1705847 (UMLS CUI [5,1])
    C0006826 (UMLS CUI [5,2])
    C0012634 (UMLS CUI [5,3])
    C0332296 (UMLS CUI [5,4])
    Study Subject Participation Status | Therapies, Investigational | Investigational New Drugs
    Item
    participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to the first drug intake
    boolean
    C2348568 (UMLS CUI [1])
    C0949266 (UMLS CUI [2])
    C0013230 (UMLS CUI [3])
    Medical condition Impairing Study Subject Participation Status | Medical condition chronic Impairing Study Subject Participation Status | Medical condition Interferes with Interpretation Research results | Medical condition chronic Interferes with Interpretation Research results
    Item
    any acute or chronic medical condition, which could impair the ability of the patient to participate to the study or could interfere with interpretation of study results
    boolean
    C3843040 (UMLS CUI [1,1])
    C0221099 (UMLS CUI [1,2])
    C2348568 (UMLS CUI [1,3])
    C3843040 (UMLS CUI [2,1])
    C0205191 (UMLS CUI [2,2])
    C0221099 (UMLS CUI [2,3])
    C2348568 (UMLS CUI [2,4])
    C3843040 (UMLS CUI [3,1])
    C0521102 (UMLS CUI [3,2])
    C0459471 (UMLS CUI [3,3])
    C0683954 (UMLS CUI [3,4])
    C3843040 (UMLS CUI [4,1])
    C0205191 (UMLS CUI [4,2])
    C0521102 (UMLS CUI [4,3])
    C0459471 (UMLS CUI [4,4])
    C0683954 (UMLS CUI [4,5])
    Diabetic - poor control
    Item
    uncontrolled diabetes mellitus
    boolean
    C0421258 (UMLS CUI [1])
    Uncontrolled hypertension
    Item
    uncontrolled hypertension
    boolean
    C1868885 (UMLS CUI [1])
    Abnormal renal function
    Item
    abnormal kidney function
    boolean
    C0151746 (UMLS CUI [1])
    Bleeding tendency | Wound, non-healing | Blood Coagulation Disorder
    Item
    evidence of clinically significant bleeding diathesis, non-healing wound or underlying coagulopathy
    boolean
    C1458140 (UMLS CUI [1])
    C0750433 (UMLS CUI [2])
    C0005779 (UMLS CUI [3])
    Pregnancy | Breast Feeding | Females & males of reproductive potential Contraceptive methods Absent
    Item
    pregnant or breast-feeding woman, or patient with reproductive potential (male, female) without an effective method of contraception
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C4034483 (UMLS CUI [3,1])
    C0700589 (UMLS CUI [3,2])
    C0332197 (UMLS CUI [3,3])
    Hypersensitivity TRAP | Hypersensitivity Recombinant Proteins
    Item
    history of hypersensitivity to any trap agents or recombinant proteins
    boolean
    C0020517 (UMLS CUI [1,1])
    C0297331 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0034861 (UMLS CUI [2,2])
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