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ID

41200

Beschrijving

A Study of MabThera Added to Bendamustine or Chlorambucil in Patients With Chronic Lymphocytic Leukemia (MaBLe); ODM derived from: https://clinicaltrials.gov/show/NCT01056510

Link

https://clinicaltrials.gov/show/NCT01056510

Trefwoorden

  1. 11-07-20 11-07-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

11 juli 2020

DOI

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Licentie

Creative Commons BY 4.0

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    Eligibility Lymphocytic Leukemia, Chronic NCT01056510

    Eligibility Lymphocytic Leukemia, Chronic NCT01056510

    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

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

    Adult | Age

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001675
    UMLS CUI [2]
    C0001779
    chronic lymphocytic leukemia
    Beschrijving

    Chronic Lymphocytic Leukemia

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0023434
    active cll with progressive binet stage b or c
    Beschrijving

    Chronic Lymphocytic Leukemia Binet Staging System

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0023434
    UMLS CUI [1,2]
    C1511118
    ineligible for treatment with fludarabine
    Beschrijving

    Patient Ineligible Fludarabine

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C1512714
    UMLS CUI [1,3]
    C0059985
    for second line patients, only pretreatment with rituximab and/or chlorambucil is allowed
    Beschrijving

    Second line treatment | Pretreatment Rituximab | Pretreatment Chlorambucil

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1710038
    UMLS CUI [2,1]
    C3539076
    UMLS CUI [2,2]
    C0393022
    UMLS CUI [3,1]
    C3539076
    UMLS CUI [3,2]
    C0008163
    eocg performance status >/=2
    Beschrijving

    ECOG performance status

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patients who have relapsed within <12 months of first dose of prior rituximab or chlorambucil first-line therapy
    Beschrijving

    Recurrent disease | Status post Rituximab | Status post Chlorambucil First line treatment

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0277556
    UMLS CUI [2,1]
    C0231290
    UMLS CUI [2,2]
    C0393022
    UMLS CUI [3,1]
    C0231290
    UMLS CUI [3,2]
    C0008163
    UMLS CUI [3,3]
    C1708063
    previous or planned stem cell transplantation
    Beschrijving

    Stem cell transplant Previous | Stem cell transplant Planned

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1504389
    UMLS CUI [1,2]
    C0205156
    UMLS CUI [2,1]
    C1504389
    UMLS CUI [2,2]
    C1301732
    radioimmunotherapy within 6 months prior to starting study treatment
    Beschrijving

    Radioimmunotherapy

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0085101
    transformation to aggressive b-cell malignancy
    Beschrijving

    Transformation Aggressive malignancy B-cell

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0040682
    UMLS CUI [1,2]
    C3149729
    UMLS CUI [1,3]
    C0004561
    any other concurrent anti-cancer therapy, or glucocorticoid >/=20mg daily prednisolone or equivalent
    Beschrijving

    Cancer treatment Other | Glucocorticoids | Prednisolone U/day | Equivalent

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0920425
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [2]
    C0017710
    UMLS CUI [3,1]
    C0032950
    UMLS CUI [3,2]
    C0456683
    UMLS CUI [4]
    C0205163

    Similar models

    Eligibility Lymphocytic Leukemia, Chronic NCT01056510

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Adult | Age
    Item
    adult patients, >/=18 years of age
    boolean
    C0001675 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    Chronic Lymphocytic Leukemia
    Item
    chronic lymphocytic leukemia
    boolean
    C0023434 (UMLS CUI [1])
    Chronic Lymphocytic Leukemia Binet Staging System
    Item
    active cll with progressive binet stage b or c
    boolean
    C0023434 (UMLS CUI [1,1])
    C1511118 (UMLS CUI [1,2])
    Patient Ineligible Fludarabine
    Item
    ineligible for treatment with fludarabine
    boolean
    C0030705 (UMLS CUI [1,1])
    C1512714 (UMLS CUI [1,2])
    C0059985 (UMLS CUI [1,3])
    Second line treatment | Pretreatment Rituximab | Pretreatment Chlorambucil
    Item
    for second line patients, only pretreatment with rituximab and/or chlorambucil is allowed
    boolean
    C1710038 (UMLS CUI [1])
    C3539076 (UMLS CUI [2,1])
    C0393022 (UMLS CUI [2,2])
    C3539076 (UMLS CUI [3,1])
    C0008163 (UMLS CUI [3,2])
    ECOG performance status
    Item
    eocg performance status >/=2
    boolean
    C1520224 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Recurrent disease | Status post Rituximab | Status post Chlorambucil First line treatment
    Item
    patients who have relapsed within <12 months of first dose of prior rituximab or chlorambucil first-line therapy
    boolean
    C0277556 (UMLS CUI [1])
    C0231290 (UMLS CUI [2,1])
    C0393022 (UMLS CUI [2,2])
    C0231290 (UMLS CUI [3,1])
    C0008163 (UMLS CUI [3,2])
    C1708063 (UMLS CUI [3,3])
    Stem cell transplant Previous | Stem cell transplant Planned
    Item
    previous or planned stem cell transplantation
    boolean
    C1504389 (UMLS CUI [1,1])
    C0205156 (UMLS CUI [1,2])
    C1504389 (UMLS CUI [2,1])
    C1301732 (UMLS CUI [2,2])
    Radioimmunotherapy
    Item
    radioimmunotherapy within 6 months prior to starting study treatment
    boolean
    C0085101 (UMLS CUI [1])
    Transformation Aggressive malignancy B-cell
    Item
    transformation to aggressive b-cell malignancy
    boolean
    C0040682 (UMLS CUI [1,1])
    C3149729 (UMLS CUI [1,2])
    C0004561 (UMLS CUI [1,3])
    Cancer treatment Other | Glucocorticoids | Prednisolone U/day | Equivalent
    Item
    any other concurrent anti-cancer therapy, or glucocorticoid >/=20mg daily prednisolone or equivalent
    boolean
    C0920425 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0017710 (UMLS CUI [2])
    C0032950 (UMLS CUI [3,1])
    C0456683 (UMLS CUI [3,2])
    C0205163 (UMLS CUI [4])

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