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ID

21066

Descrizione

An Efficacy and Tolerability Study of Bortezomib in Combination With Rituximab Standard Therapy in Participants With Relapsed or Refractory Follicular Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01902862

collegamento

https://clinicaltrials.gov/show/NCT01902862

Keywords

versioni (1)
  1. 07/04/17 07/04/17 -
Caricato su

7 aprile 2017

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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    Eligibility Lymphoma, Follicular NCT01902862

    Inglese

    Eligibility Lymphoma, Follicular NCT01902862

    1 moduli  
    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    participants with histologically confirmed relapsed or refractory follicular stage iii or iv, grade 1 and 2, cluster of differentiation 20 plus (cd20+) lymphoma (who-world health organization) that requires therapy
    Descrizione

    Lymphoma, Follicular; histological diagnosis; Recurrent disease; Refractory Disease | Lymphoma stage | Cell positive for CD20 antigen

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0024301 (Lymphoma, Follicular)
    SNOMED
    55150002
    UMLS CUI [1,2]
    C0679557 (histological diagnosis)
    UMLS CUI [1,3]
    C0277556 (Recurrent disease)
    SNOMED
    58184002
    UMLS CUI [1,4]
    C1514815 (Refractory Disease)
    UMLS CUI [2]
    C1272836 (Lymphoma stage)
    SNOMED
    385388004
    UMLS CUI [3]
    C0882818 (Cell positive for CD20 antigen)
    SNOMED
    116754005
    participants in whom treatment with rituximab is planned after greater than or equal to 2 cytostatic (inhibition of cell growth) previous therapies
    Descrizione

    rituximab planned, prior chemotherapy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0393022 (rituximab)
    SNOMED
    108809004
    UMLS CUI [1,2]
    C1301732 (Planned)
    SNOMED
    397943006
    LOINC
    LA20099-0
    UMLS CUI [2]
    C1514457 (Prior Chemotherapy)
    women must be either postmenopausal or sterilized; negative pregnancy test at screening
    Descrizione

    postmenopausal state, sterilized, pregnancy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0232970 (Postmenopausal state)
    SNOMED
    76498008
    UMLS CUI [2]
    C0015787 (Female Sterilization)
    SNOMED
    169549004
    UMLS CUI [3]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    participants with total bilirubin below 1.5-fold upper limit of normal (uln) and creatinine below 2-fold uln
    Descrizione

    total bilirubin, creatinine

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0201913 (Bilirubin, total measurement)
    SNOMED
    359986008
    UMLS CUI [2]
    C0201976 (Creatinine measurement, serum (procedure))
    SNOMED
    113075003
    participants with karnofsky status greater than or equal to 60 percent
    Descrizione

    karnofsky

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0206065 (Karnofsky Performance Status)
    SNOMED
    273546003
    LOINC
    LP267177-6
    Exclusion Criteria
    Descrizione

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    participants with previous treatment with bortezomib within 6 months before enrollment or previous treatment with a combination of rituximab and bortezomib
    Descrizione

    Prior Therapy; bortezomib | Prior Therapy; bortezomib/rituximab

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463 (Prior Therapy)
    UMLS CUI [1,2]
    C1176309 (bortezomib)
    SNOMED
    398907002
    UMLS CUI [2,1]
    C1514463 (Prior Therapy)
    UMLS CUI [2,2]
    C1541445 (bortezomib/rituximab)
    participants with previous known allergic reaction to bortezomib, boron or mannitol
    Descrizione

    previous known allergic reaction to bortezomib, boron or mannitol

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C1176309 (bortezomib)
    SNOMED
    398907002
    UMLS CUI [2,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [2,2]
    C0024730 (mannitol)
    SNOMED
    30761007
    UMLS CUI [3,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [3,2]
    C0006030 (boron)
    SNOMED
    70597009
    participants with life-expectancy of less than 3 months
    Descrizione

    life-expectancy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0023671 (Life Expectancy)
    participants with malignant neoplasm (cancerous - new growth that is not normal; tumor) (except basalioma) within previous 5 years
    Descrizione

    history of cancer, basalioma

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C2735088 (undefined)
    UMLS CUI [2]
    C0007117 (Basal cell carcinoma)
    SNOMED
    1338007
    participants with peripheral (not central) neuropathy (a disturbance in the function of the brain or spinal cord that may affect the nerves and muscles of the body) common terminology criteria for adverse events (ctcae) grade greater than or equal to 2
    Descrizione

    peripheral neuropathy, common terminology criteria for adverse events (ctcae)

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0031117 (Peripheral Neuropathy)
    UMLS CUI [1,2]
    C3888020 (Common Terminology Criteria for Adverse Events)
    Ritorna all'inizio della pagina

    Similar models

    Eligibility Lymphoma, Follicular NCT01902862

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Lymphoma, Follicular; histological diagnosis; Recurrent disease; Refractory Disease | Lymphoma stage | Cell positive for CD20 antigen
    Item
    participants with histologically confirmed relapsed or refractory follicular stage iii or iv, grade 1 and 2, cluster of differentiation 20 plus (cd20+) lymphoma (who-world health organization) that requires therapy
    boolean
    C0024301 (UMLS CUI [1,1])
    C0679557 (UMLS CUI [1,2])
    C0277556 (UMLS CUI [1,3])
    C1514815 (UMLS CUI [1,4])
    C1272836 (UMLS CUI [2])
    C0882818 (UMLS CUI [3])
    rituximab planned, prior chemotherapy
    Item
    participants in whom treatment with rituximab is planned after greater than or equal to 2 cytostatic (inhibition of cell growth) previous therapies
    boolean
    C0393022 (UMLS CUI [1,1])
    C1301732 (UMLS CUI [1,2])
    C1514457 (UMLS CUI [2])
    postmenopausal state, sterilized, pregnancy
    Item
    women must be either postmenopausal or sterilized; negative pregnancy test at screening
    boolean
    C0232970 (UMLS CUI [1])
    C0015787 (UMLS CUI [2])
    C0032961 (UMLS CUI [3])
    total bilirubin, creatinine
    Item
    participants with total bilirubin below 1.5-fold upper limit of normal (uln) and creatinine below 2-fold uln
    boolean
    C0201913 (UMLS CUI [1])
    C0201976 (UMLS CUI [2])
    karnofsky
    Item
    participants with karnofsky status greater than or equal to 60 percent
    boolean
    C0206065 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Prior Therapy; bortezomib | Prior Therapy; bortezomib/rituximab
    Item
    participants with previous treatment with bortezomib within 6 months before enrollment or previous treatment with a combination of rituximab and bortezomib
    boolean
    C1514463 (UMLS CUI [1,1])
    C1176309 (UMLS CUI [1,2])
    C1514463 (UMLS CUI [2,1])
    C1541445 (UMLS CUI [2,2])
    previous known allergic reaction to bortezomib, boron or mannitol
    Item
    participants with previous known allergic reaction to bortezomib, boron or mannitol
    boolean
    C0020517 (UMLS CUI [1,1])
    C1176309 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0024730 (UMLS CUI [2,2])
    C0020517 (UMLS CUI [3,1])
    C0006030 (UMLS CUI [3,2])
    life-expectancy
    Item
    participants with life-expectancy of less than 3 months
    boolean
    C0023671 (UMLS CUI [1])
    history of cancer, basalioma
    Item
    participants with malignant neoplasm (cancerous - new growth that is not normal; tumor) (except basalioma) within previous 5 years
    boolean
    C2735088 (UMLS CUI [1])
    C0007117 (UMLS CUI [2])
    peripheral neuropathy, common terminology criteria for adverse events (ctcae)
    Item
    participants with peripheral (not central) neuropathy (a disturbance in the function of the brain or spinal cord that may affect the nerves and muscles of the body) common terminology criteria for adverse events (ctcae) grade greater than or equal to 2
    boolean
    C0031117 (UMLS CUI [1,1])
    C3888020 (UMLS CUI [1,2])
    Ritorna all'inizio della pagina 

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