ID

11984

Beschrijving

Efficacy and Safety of Idelalisib in Combination With Obinutuzumab Compared to Chlorambucil in Combination With Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01980875

Link

https://clinicaltrials.gov/show/NCT01980875

Trefwoorden

  1. 30-08-15 30-08-15 -
Houder van rechten

https://clinicaltrials.gov/show/NCT01980875

Geüploaded op

30 augustus 2015

DOI

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Licentie

Creative Commons BY 4.0

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    Eligibility Chronic Lymphocytic Leukemia NCT01980875

    Eligibility Chronic Lymphocytic Leukemia NCT01980875

    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    not a candidate for fludarabine therapy based on either:
    Beschrijving

    therapy

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0087111
    1. creatinine clearance < 70 ml/min, or
    Beschrijving

    creatinine clearance

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0373595
    2. cumulative illness rating scale score > 6, by assessment of the investigator
    Beschrijving

    investigator; assessment; score

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0582608
    diagnosis of b-cell cll, with diagnosis established according to international workshop on chronic lymphocytic leukemia (iwcll)
    Beschrijving

    diagnosis; leukemia; chronic; cll

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0023434
    no prior therapy for cll other than corticosteroids for disease complications.
    Beschrijving

    corticosteroids; complications; prior therapy; other; disease; cll

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0023434
    cll that warrants treatment
    Beschrijving

    treatment; cll

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0087111
    UMLS CUI [2]
    C0023434
    presence of measurable lymphadenopathy
    Beschrijving

    measurable

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0497156
    eastern cooperative oncology group (ecog) performance status of ≤ 2
    Beschrijving

    eastern cooperative oncology group (ecog) performance status < 1; eastern cooperative oncology group (ecog) performance status 0-2

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    known histological transformation from cll to an aggressive lymphoma (ie, richter transformation)
    Beschrijving

    lymphoma; from; cll

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0349631
    known presence of myelodysplastic syndrome
    Beschrijving

    myelodysplastic syndrome

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C3463824
    evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization
    Beschrijving

    randomization; evidence of; infection; systemic; ongoing; viral; time

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0243026
    ongoing liver injury
    Beschrijving

    ongoing; liver

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0160390
    ongoing drug-induced pneumonitis
    Beschrijving

    pneumonitis; ongoing; drug

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C3714636
    ongoing inflammatory bowel disease
    Beschrijving

    inflammatory; disease; ongoing

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0021390
    history of prior allogeneic bone marrow progenitor cell or solid organ transplantation
    Beschrijving

    organ transplantation; bone marrow; solid organ

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0029216
    UMLS CUI [2]
    C0149615
    ongoing immunosuppressive therapy other than corticosteroids
    Beschrijving

    corticosteroids; other; ongoing; therapy

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0021079
    concurrent participation in another therapeutic clinical trial
    Beschrijving

    clinical trial

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0008976
    undergone major surgery within 30 days prior to randomization
    Beschrijving

    major surgery; randomization

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0679637
    known hypersensitivity or intolerance to any of the active substances or excipients in the formulations for idela, obinutuzumab, or chlorambucil
    Beschrijving

    hypersensitivity; active substance

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C1254351
    history of non-infectious pneumonitis
    Beschrijving

    pneumonitis; non

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0264376
    received last dose of study drug on another therapeutic clinical trial within 30 days prior to randomization
    Beschrijving

    clinical trial; randomization; study; dose; last; drug

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0013175

    Similar models

    Eligibility Chronic Lymphocytic Leukemia NCT01980875

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    therapy
    Item
    not a candidate for fludarabine therapy based on either:
    boolean
    C0087111 (UMLS CUI [1])
    creatinine clearance
    Item
    1. creatinine clearance < 70 ml/min, or
    boolean
    C0373595 (UMLS CUI [1])
    investigator; assessment; score
    Item
    2. cumulative illness rating scale score > 6, by assessment of the investigator
    boolean
    C0582608 (UMLS CUI [1])
    diagnosis; leukemia; chronic; cll
    Item
    diagnosis of b-cell cll, with diagnosis established according to international workshop on chronic lymphocytic leukemia (iwcll)
    boolean
    C0023434 (UMLS CUI [1])
    corticosteroids; complications; prior therapy; other; disease; cll
    Item
    no prior therapy for cll other than corticosteroids for disease complications.
    boolean
    C0023434 (UMLS CUI [1])
    treatment; cll
    Item
    cll that warrants treatment
    boolean
    C0087111 (UMLS CUI [1])
    C0023434 (UMLS CUI [2])
    measurable
    Item
    presence of measurable lymphadenopathy
    boolean
    C0497156 (UMLS CUI [1])
    eastern cooperative oncology group (ecog) performance status < 1; eastern cooperative oncology group (ecog) performance status 0-2
    Item
    eastern cooperative oncology group (ecog) performance status of ≤ 2
    boolean
    C1520224 (UMLS CUI [1])
    lymphoma; from; cll
    Item
    known histological transformation from cll to an aggressive lymphoma (ie, richter transformation)
    boolean
    C0349631 (UMLS CUI [1])
    myelodysplastic syndrome
    Item
    known presence of myelodysplastic syndrome
    boolean
    C3463824 (UMLS CUI [1])
    randomization; evidence of; infection; systemic; ongoing; viral; time
    Item
    evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization
    boolean
    C0243026 (UMLS CUI [1])
    ongoing; liver
    Item
    ongoing liver injury
    boolean
    C0160390 (UMLS CUI [1])
    pneumonitis; ongoing; drug
    Item
    ongoing drug-induced pneumonitis
    boolean
    C3714636 (UMLS CUI [1])
    inflammatory; disease; ongoing
    Item
    ongoing inflammatory bowel disease
    boolean
    C0021390 (UMLS CUI [1])
    organ transplantation; bone marrow; solid organ
    Item
    history of prior allogeneic bone marrow progenitor cell or solid organ transplantation
    boolean
    C0029216 (UMLS CUI [1])
    C0149615 (UMLS CUI [2])
    corticosteroids; other; ongoing; therapy
    Item
    ongoing immunosuppressive therapy other than corticosteroids
    boolean
    C0021079 (UMLS CUI [1])
    clinical trial
    Item
    concurrent participation in another therapeutic clinical trial
    boolean
    C0008976 (UMLS CUI [1])
    major surgery; randomization
    Item
    undergone major surgery within 30 days prior to randomization
    boolean
    C0679637 (UMLS CUI [1])
    hypersensitivity; active substance
    Item
    known hypersensitivity or intolerance to any of the active substances or excipients in the formulations for idela, obinutuzumab, or chlorambucil
    boolean
    C0020517 (UMLS CUI [1,1])
    C1254351 (UMLS CUI [1,2])
    pneumonitis; non
    Item
    history of non-infectious pneumonitis
    boolean
    C0264376 (UMLS CUI [1])
    clinical trial; randomization; study; dose; last; drug
    Item
    received last dose of study drug on another therapeutic clinical trial within 30 days prior to randomization
    boolean
    C0013175 (UMLS CUI [1])

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