ID

41219

Description

A Study of MabThera (Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma.; ODM derived from: https://clinicaltrials.gov/show/NCT01144403

Link

https://clinicaltrials.gov/show/NCT01144403

Keywords

Versions (1)
  1. 7/18/20 7/18/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 18, 2020

DOI

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License

Creative Commons BY 4.0
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    Eligibility Lymphoma, B-Cell NCT01144403

    English

    Eligibility Lymphoma, B-Cell NCT01144403

    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
    untreated mantle cell lymphoma, not eligible for autologous stem cell transplantation
    Description

    Mantle cell lymphoma Untreated | Ineligibility Autologous hematopoietic stem cell transplant

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0334634
    UMLS CUI [1,2]
    C0332155
    UMLS CUI [2,1]
    C1512714
    UMLS CUI [2,2]
    C2193200
    known mantle cell lymphoma international prognostic index (mipi) at diagnosis
    Description

    MIPI - Mantle Cell Lymphoma International Prognostic Index

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C4706335
    ecog performance status 0-2
    Description

    ECOG performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    adequate hematological, renal and hepatic function
    Description

    Hematologic function | Renal function | Liver function

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0221130
    UMLS CUI [2]
    C0232804
    UMLS CUI [3]
    C0232741
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    known hypersensitivity to murine proteins or chemotherapy regimen
    Description

    Hypersensitivity Murine protein | Hypersensitivity Chemotherapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C1699668
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0392920
    previous first-line therapy
    Description

    First line treatment Previous

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1708063
    UMLS CUI [1,2]
    C0205156
    history of other malignancy within the last 5 years, except for squamous cell carcinoma, basal cell carcinoma of the skin or in situ cervical carcinoma
    Description

    Cancer Other | Exception Squamous cell carcinoma | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1707251
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0007137
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0007117
    UMLS CUI [4,1]
    C1705847
    UMLS CUI [4,2]
    C0851140
    active infection
    Description

    Communicable Disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009450
    clinically significant cardiac disease
    Description

    Heart Disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0018799
    regular corticosteroid treatment in the 4 weeks prior to first dose of study drug
    Description

    Steroid therapy Regular

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0149783
    UMLS CUI [1,2]
    C0205272
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    Similar models

    Eligibility Lymphoma, B-Cell NCT01144403

    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])
    Mantle cell lymphoma Untreated | Ineligibility Autologous hematopoietic stem cell transplant
    Item
    untreated mantle cell lymphoma, not eligible for autologous stem cell transplantation
    boolean
    C0334634 (UMLS CUI [1,1])
    C0332155 (UMLS CUI [1,2])
    C1512714 (UMLS CUI [2,1])
    C2193200 (UMLS CUI [2,2])
    MIPI - Mantle Cell Lymphoma International Prognostic Index
    Item
    known mantle cell lymphoma international prognostic index (mipi) at diagnosis
    boolean
    C4706335 (UMLS CUI [1])
    ECOG performance status
    Item
    ecog performance status 0-2
    boolean
    C1520224 (UMLS CUI [1])
    Hematologic function | Renal function | Liver function
    Item
    adequate hematological, renal and hepatic function
    boolean
    C0221130 (UMLS CUI [1])
    C0232804 (UMLS CUI [2])
    C0232741 (UMLS CUI [3])
    Item Group
    C0680251 (UMLS CUI)
    Hypersensitivity Murine protein | Hypersensitivity Chemotherapy
    Item
    known hypersensitivity to murine proteins or chemotherapy regimen
    boolean
    C0020517 (UMLS CUI [1,1])
    C1699668 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0392920 (UMLS CUI [2,2])
    First line treatment Previous
    Item
    previous first-line therapy
    boolean
    C1708063 (UMLS CUI [1,1])
    C0205156 (UMLS CUI [1,2])
    Cancer Other | Exception Squamous cell carcinoma | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix
    Item
    history of other malignancy within the last 5 years, except for squamous cell carcinoma, basal cell carcinoma of the skin or in situ cervical carcinoma
    boolean
    C1707251 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0007137 (UMLS CUI [2,2])
    C1705847 (UMLS CUI [3,1])
    C0007117 (UMLS CUI [3,2])
    C1705847 (UMLS CUI [4,1])
    C0851140 (UMLS CUI [4,2])
    Communicable Disease
    Item
    active infection
    boolean
    C0009450 (UMLS CUI [1])
    Heart Disease
    Item
    clinically significant cardiac disease
    boolean
    C0018799 (UMLS CUI [1])
    Steroid therapy Regular
    Item
    regular corticosteroid treatment in the 4 weeks prior to first dose of study drug
    boolean
    C0149783 (UMLS CUI [1,1])
    C0205272 (UMLS CUI [1,2])
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