ID

12788

Description

CASPALLO: Allodepleted T Cells Transduced With Inducible Caspase 9 Suicide Gene; ODM derived from: https://clinicaltrials.gov/show/NCT00710892

Link

https://clinicaltrials.gov/show/NCT00710892

Keywords

  1. 12/21/15 12/21/15 -
Uploaded on

December 21, 2015

DOI

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License

Creative Commons BY 4.0

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    Eligibility Acute Lymphoblastic Leukemia NCT00710892

    Eligibility Acute Lymphoblastic Leukemia NCT00710892

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    at the time of transplant:
    Description

    time of transplant

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3262320
    patients (up to 65 years of age) with:
    Description

    age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    all or high grade nhl that is stage iii or iv and has relapsed or is considered to be primary refractory disease.
    Description

    all or high grade nhl

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023449
    UMLS CUI [2]
    C0024305
    myelodysplastic syndrome.
    Description

    myelodysplastic syndrome

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3463824
    aml after first relapse or with primary refractory disease.
    Description

    aml after first relapse or with primary refractory disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2367456
    UMLS CUI [2]
    C1514815
    cml
    Description

    cml

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0279899
    hemophagocytic lymphohistiocytosis (hlh); familial hemophagocytic lymphohistiocytosis (flh); viral-associated hemophagocytic syndrome (vahs); patients with severe chronic active epstein barr virus infection (scaebv) with predilection for t or nk cell malignancy; x-linked lymphoproliferative disease (xlp)
    Description

    hemophagocytic lymphohistiocytosis (hlh); familial hemophagocytic lymphohistiocytosis (flh); viral-associated hemophagocytic syndrome (vahs); patients with severe chronic active epstein barr virus infection

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0024291
    UMLS CUI [2]
    C0272199
    UMLS CUI [3]
    C0019068
    UMLS CUI [4]
    C0549463
    UMLS CUI [5]
    C0149678
    lack of suitable conventional donor (i.e. 5/6 or 6/6 related, or 5/6 or 6/6 unrelated donor) or presence of a rapidly progressive disease not permitting time to identify an unrelated donor.
    Description

    lack of suitable conventional donor (i.e. 5/6 or 6/6 related, or 5/6 or 6/6 unrelated donor) or presence of a rapidly progressive disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013018
    UMLS CUI [2]
    C1335499
    at the time of allodepleted t cell infusion:
    Description

    allodepleted t cell infusion

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3897408
    engrafted with anc greater than 500.
    Description

    anc

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0948762
    must have greater than or equal to 50 percent donor chimerism in either peripheral blood or bone marrow, or relapse of their original disease.
    Description

    must have greater than or equal to 50 percent donor chimerism in either peripheral blood or bone marrow, or relapse of their original disease.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3250865
    UMLS CUI [2]
    C0277556
    life expectancy greater than 30 days
    Description

    life expectancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    lansky/karnofsky scores greater than or equal to 60
    Description

    karnofsky

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0206065
    absence of severe renal disease (creatinine greater than 2x normal for age)
    Description

    renal disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0022658
    absence of severe hepatic disease (direct bilirubin greater than 2 mg/dl, or sgot greater than 200
    Description

    liver disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023895
    oxygen saturation greater than 94 percent on room air
    Description

    spo2

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0428179
    patient/guardian able to give informed consent
    Description

    informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    at the time of transplant:
    Description

    at the time of transplant

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3262320
    pregnancy
    Description

    pregnancy test only required for at-risk individuals, defined as female patients of childbearing potential who have received a reduced-intensity conditioning regimen.

    Data type

    boolean

    at the time of allodepleted t cell infusion:
    Description

    at the time of allodepleted t cell infusion

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3897408
    gvhd
    Description

    gvhd

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0018133
    severe intercurrent infection
    Description

    infection

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009450
    pregnancy
    Description

    pregnancy test only required for at-risk individuals, defined as female patients of childbearing potential who have received a reduced-intensity conditioning regimen.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0549206
    other investigational drugs in the prior 30 days
    Description

    study subject participation status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568

    Similar models

    Eligibility Acute Lymphoblastic Leukemia NCT00710892

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    time of transplant
    Item
    at the time of transplant:
    boolean
    C3262320 (UMLS CUI [1])
    age
    Item
    patients (up to 65 years of age) with:
    boolean
    C0001779 (UMLS CUI [1])
    all or high grade nhl
    Item
    all or high grade nhl that is stage iii or iv and has relapsed or is considered to be primary refractory disease.
    boolean
    C0023449 (UMLS CUI [1])
    C0024305 (UMLS CUI [2])
    myelodysplastic syndrome
    Item
    myelodysplastic syndrome.
    boolean
    C3463824 (UMLS CUI [1])
    aml after first relapse or with primary refractory disease
    Item
    aml after first relapse or with primary refractory disease.
    boolean
    C2367456 (UMLS CUI [1])
    C1514815 (UMLS CUI [2])
    cml
    Item
    cml
    boolean
    C0279899 (UMLS CUI [1])
    hemophagocytic lymphohistiocytosis (hlh); familial hemophagocytic lymphohistiocytosis (flh); viral-associated hemophagocytic syndrome (vahs); patients with severe chronic active epstein barr virus infection
    Item
    hemophagocytic lymphohistiocytosis (hlh); familial hemophagocytic lymphohistiocytosis (flh); viral-associated hemophagocytic syndrome (vahs); patients with severe chronic active epstein barr virus infection (scaebv) with predilection for t or nk cell malignancy; x-linked lymphoproliferative disease (xlp)
    boolean
    C0024291 (UMLS CUI [1])
    C0272199 (UMLS CUI [2])
    C0019068 (UMLS CUI [3])
    C0549463 (UMLS CUI [4])
    C0149678 (UMLS CUI [5])
    lack of suitable conventional donor (i.e. 5/6 or 6/6 related, or 5/6 or 6/6 unrelated donor) or presence of a rapidly progressive disease
    Item
    lack of suitable conventional donor (i.e. 5/6 or 6/6 related, or 5/6 or 6/6 unrelated donor) or presence of a rapidly progressive disease not permitting time to identify an unrelated donor.
    boolean
    C0013018 (UMLS CUI [1])
    C1335499 (UMLS CUI [2])
    allodepleted t cell infusion
    Item
    at the time of allodepleted t cell infusion:
    boolean
    C3897408 (UMLS CUI [1])
    anc
    Item
    engrafted with anc greater than 500.
    boolean
    C0948762 (UMLS CUI [1])
    must have greater than or equal to 50 percent donor chimerism in either peripheral blood or bone marrow, or relapse of their original disease.
    Item
    must have greater than or equal to 50 percent donor chimerism in either peripheral blood or bone marrow, or relapse of their original disease.
    boolean
    C3250865 (UMLS CUI [1])
    C0277556 (UMLS CUI [2])
    life expectancy
    Item
    life expectancy greater than 30 days
    boolean
    C0023671 (UMLS CUI [1])
    karnofsky
    Item
    lansky/karnofsky scores greater than or equal to 60
    boolean
    C0206065 (UMLS CUI [1])
    renal disease
    Item
    absence of severe renal disease (creatinine greater than 2x normal for age)
    boolean
    C0022658 (UMLS CUI [1])
    liver disease
    Item
    absence of severe hepatic disease (direct bilirubin greater than 2 mg/dl, or sgot greater than 200
    boolean
    C0023895 (UMLS CUI [1])
    spo2
    Item
    oxygen saturation greater than 94 percent on room air
    boolean
    C0428179 (UMLS CUI [1])
    informed consent
    Item
    patient/guardian able to give informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    at the time of transplant
    Item
    at the time of transplant:
    boolean
    C3262320 (UMLS CUI [1])
    pregnancy
    Item
    pregnancy
    boolean
    at the time of allodepleted t cell infusion
    Item
    at the time of allodepleted t cell infusion:
    boolean
    C3897408 (UMLS CUI [1])
    gvhd
    Item
    gvhd
    boolean
    C0018133 (UMLS CUI [1])
    infection
    Item
    severe intercurrent infection
    boolean
    C0009450 (UMLS CUI [1])
    pregnancy
    Item
    pregnancy
    boolean
    C0549206 (UMLS CUI [1])
    study subject participation status
    Item
    other investigational drugs in the prior 30 days
    boolean
    C2348568 (UMLS CUI [1])

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