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ID

12650

Beskrivning

Multi-virus CTLs Expressing CD19 Chimeric Receptors, CD19 Positive Malignancies Post SCT, MULTIPRAT; ODM derived from: https://clinicaltrials.gov/show/NCT00840853

Länk

https://clinicaltrials.gov/show/NCT00840853

Nyckelord

  1. 2015-12-07 2015-12-07 -
Uppladdad den

7 december 2015

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility Acute Lymphoblastic Leukemia (ALL) NCT00840853

    Eligibility Acute Lymphoblastic Leukemia (ALL) NCT00840853

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    any patient regardless of sex or age with cd19+ b-all undergoing allogeneic hsct (group a)
    Beskrivning

    any patient regardless of sex or age with cd19+ b-all undergoing allogeneic hsct (group a)

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2698589
    UMLS CUI [2]
    C0006413
    UMLS CUI [3]
    C1705576
    or any patient regardless of sex or age with cd19+ b-cll or nhl undergoing allogeneic hsct (group b).
    Beskrivning

    or any patient regardless of sex or age with cd19+ b-cll or nhl undergoing allogeneic hsct (group b)

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2698589
    UMLS CUI [2]
    C0023434
    UMLS CUI [3]
    C0024305
    UMLS CUI [4]
    C1705576
    with minimal residual disease (mrd) or relapse post-hsct (for the phase i dose escalation)
    Beskrivning

    with minimal residual disease (mrd) or relapse post-hsct (for the phase i dose escalation)

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0543478
    UMLS CUI [2]
    C0277556
    with no evidence of all or cll/nhl post-hsct (to be included in the expansion cohort
    Beskrivning

    with no evidence of all or cll/nhl post-hsct (to be included in the expansion cohort

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0153876
    UMLS CUI [2]
    C1705576
    patients with life expectancy greater than or equal to 6 weeks
    Beskrivning

    life expectancy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    patients with a karnofsky/lansky score greater than or equal to 50
    Beskrivning

    karnofsky/lansky score

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0206065
    donor hiv negative
    Beskrivning

    donor hiv negative

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0481430
    5. patient or parent/guardian capable of providing informed consent
    Beskrivning

    informed consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    patients with bilirubin 2x normal or less, ast 3x normal or less, creatinine less than or equal to 2x normal for age and hgb greater than 8.0
    Beskrivning

    patients with bilirubin 2x normal or less, ast 3x normal or less, creatinine less than or equal to 2x normal for age and hgb greater than 8.0

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1278039
    UMLS CUI [2]
    C0428321
    UMLS CUI [3]
    C0201976
    UMLS CUI [4]
    C0019046
    pulse oximetry of greater than 90 percent on room air
    Beskrivning

    pulse oximetry

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0034108
    sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the ctl infusion. the male partner should use a condom.
    Beskrivning

    sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the ctl infusion. the male partner should use a condom.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0700589
    available allogeneic cd19car transduced tri-virus-specific cytotoxic t lymphocytes with greater than or equal to 15 percent expression of cd19car determined by flow-cytometry and greater than 10 percent killing of one or more viral antigen pulsed targets in a cytotoxicity assay at an effector:target ratio of 20:1.*
    Beskrivning

    available allogeneic cd19car transduced tri-virus-specific cytotoxic t lymphocytes with greater than or equal to 15 percent expression of cd19car determined by flow-cytometry and greater than 10 percent killing of one or more viral antigen pulsed targets in a cytotoxicity assay at an effector:target ratio of 20:1.*

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2981182
    UMLS CUI [2]
    C0201622
    patients should have been off other investigational antiviral or antitumor therapy for one month prior to entry in this study.
    Beskrivning

    study subject participation status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    note: cell dose is based on total cell numbers and not individual antivirus or antileukemic cell numbers.
    Beskrivning

    note: cell dose is based on total cell numbers and not individual antivirus or antileukemic cell numbers

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0005771
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    severe intercurrent infection
    Beskrivning

    infection

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0009450
    evidence of graft versus host disease >grade ii
    Beskrivning

    graft versus host disease

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0018133
    pregnant or lactating
    Beskrivning

    pregnant or lactating

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0006147
    history of hypersensitivity reactions to murine protein-containing products.
    Beskrivning

    history of hypersensitivity reactions to murine protein-containing products.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0020517
    UMLS CUI [2]
    C1699668
    currently taking corticosteroids for therapy of gvhd.
    Beskrivning

    corticosteroids gvhd

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0149783

    Similar models

    Eligibility Acute Lymphoblastic Leukemia (ALL) NCT00840853

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    any patient regardless of sex or age with cd19+ b-all undergoing allogeneic hsct (group a)
    Item
    any patient regardless of sex or age with cd19+ b-all undergoing allogeneic hsct (group a)
    boolean
    C2698589 (UMLS CUI [1])
    C0006413 (UMLS CUI [2])
    C1705576 (UMLS CUI [3])
    or any patient regardless of sex or age with cd19+ b-cll or nhl undergoing allogeneic hsct (group b)
    Item
    or any patient regardless of sex or age with cd19+ b-cll or nhl undergoing allogeneic hsct (group b).
    boolean
    C2698589 (UMLS CUI [1])
    C0023434 (UMLS CUI [2])
    C0024305 (UMLS CUI [3])
    C1705576 (UMLS CUI [4])
    with minimal residual disease (mrd) or relapse post-hsct (for the phase i dose escalation)
    Item
    with minimal residual disease (mrd) or relapse post-hsct (for the phase i dose escalation)
    boolean
    C0543478 (UMLS CUI [1])
    C0277556 (UMLS CUI [2])
    with no evidence of all or cll/nhl post-hsct (to be included in the expansion cohort
    Item
    with no evidence of all or cll/nhl post-hsct (to be included in the expansion cohort
    boolean
    C0153876 (UMLS CUI [1])
    C1705576 (UMLS CUI [2])
    life expectancy
    Item
    patients with life expectancy greater than or equal to 6 weeks
    boolean
    C0023671 (UMLS CUI [1])
    karnofsky/lansky score
    Item
    patients with a karnofsky/lansky score greater than or equal to 50
    boolean
    C0206065 (UMLS CUI [1])
    donor hiv negative
    Item
    donor hiv negative
    boolean
    C0481430 (UMLS CUI [1])
    informed consent
    Item
    5. patient or parent/guardian capable of providing informed consent
    boolean
    C0021430 (UMLS CUI [1])
    patients with bilirubin 2x normal or less, ast 3x normal or less, creatinine less than or equal to 2x normal for age and hgb greater than 8.0
    Item
    patients with bilirubin 2x normal or less, ast 3x normal or less, creatinine less than or equal to 2x normal for age and hgb greater than 8.0
    boolean
    C1278039 (UMLS CUI [1])
    C0428321 (UMLS CUI [2])
    C0201976 (UMLS CUI [3])
    C0019046 (UMLS CUI [4])
    pulse oximetry
    Item
    pulse oximetry of greater than 90 percent on room air
    boolean
    C0034108 (UMLS CUI [1])
    sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the ctl infusion. the male partner should use a condom.
    Item
    sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the ctl infusion. the male partner should use a condom.
    boolean
    C0700589 (UMLS CUI [1])
    available allogeneic cd19car transduced tri-virus-specific cytotoxic t lymphocytes with greater than or equal to 15 percent expression of cd19car determined by flow-cytometry and greater than 10 percent killing of one or more viral antigen pulsed targets in a cytotoxicity assay at an effector:target ratio of 20:1.*
    Item
    available allogeneic cd19car transduced tri-virus-specific cytotoxic t lymphocytes with greater than or equal to 15 percent expression of cd19car determined by flow-cytometry and greater than 10 percent killing of one or more viral antigen pulsed targets in a cytotoxicity assay at an effector:target ratio of 20:1.*
    boolean
    C2981182 (UMLS CUI [1])
    C0201622 (UMLS CUI [2])
    study subject participation status
    Item
    patients should have been off other investigational antiviral or antitumor therapy for one month prior to entry in this study.
    boolean
    C2348568 (UMLS CUI [1])
    note: cell dose is based on total cell numbers and not individual antivirus or antileukemic cell numbers
    Item
    note: cell dose is based on total cell numbers and not individual antivirus or antileukemic cell numbers.
    boolean
    C0005771 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    infection
    Item
    severe intercurrent infection
    boolean
    C0009450 (UMLS CUI [1])
    graft versus host disease
    Item
    evidence of graft versus host disease >grade ii
    boolean
    C0018133 (UMLS CUI [1])
    pregnant or lactating
    Item
    pregnant or lactating
    boolean
    C0032961 (UMLS CUI [1,1])
    C0006147 (UMLS CUI [1,2])
    history of hypersensitivity reactions to murine protein-containing products.
    Item
    history of hypersensitivity reactions to murine protein-containing products.
    boolean
    C0020517 (UMLS CUI [1])
    C1699668 (UMLS CUI [2])
    corticosteroids gvhd
    Item
    currently taking corticosteroids for therapy of gvhd.
    boolean
    C0149783 (UMLS CUI [1])

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