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ID

37690

Description

Evaluation of 4th Generation Safety-designed CAR T Cells Targeting High-risk and Refractory B Cell Lymphomas; ODM derived from: https://clinicaltrials.gov/show/NCT02247609

Link

https://clinicaltrials.gov/show/NCT02247609

Keywords

Versions (1)
  1. 8/16/19 8/16/19 -
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See clinicaltrials.gov

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August 16, 2019

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Creative Commons BY 4.0
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    Eligibility B-cell Lymphomas NCT02247609

    English

    Eligibility B-cell Lymphomas NCT02247609

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    relapsed or refractory cd19(+) b cell lymphoma patients proved by immuno-histochemistry (ihc) or flow-cytometry.
    Description

    B-cell lymphoma recurrent CD19 Positive Immunohistochemistry | B-cell lymphoma refractory CD19 Positive Immunohistochemistry | B-cell lymphoma recurrent CD19 Positive Flow Cytometry | B-cell lymphoma refractory CD19 Positive Flow Cytometry

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0855089 (B-cell lymphoma recurrent)
    UMLS CUI [1,2]
    C4289895 (CD19 Positive)
    UMLS CUI [1,3]
    C0021044 (Immunohistochemistry)
    SNOMED
    708097004
    UMLS CUI [2,1]
    C0855090 (B-cell lymphoma refractory)
    UMLS CUI [2,2]
    C4289895 (CD19 Positive)
    UMLS CUI [2,3]
    C0021044 (Immunohistochemistry)
    SNOMED
    708097004
    UMLS CUI [3,1]
    C0855089 (B-cell lymphoma recurrent)
    UMLS CUI [3,2]
    C4289895 (CD19 Positive)
    UMLS CUI [3,3]
    C0016263 (Flow Cytometry)
    SNOMED
    708058007
    UMLS CUI [4,1]
    C0855090 (B-cell lymphoma refractory)
    UMLS CUI [4,2]
    C4289895 (CD19 Positive)
    UMLS CUI [4,3]
    C0016263 (Flow Cytometry)
    SNOMED
    708058007
    not eligible for autologous stem-cell transplantation (asct) or relapsed after asct.
    Description

    Ineligibility Autologous hematopoietic stem cell transplant | Recurrent disease Post Autologous hematopoietic stem cell transplant

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1512714 (Ineligibility)
    UMLS CUI [1,2]
    C2193200 (Autologous haematopoietic stem cell transplant)
    UMLS CUI [2,1]
    C0277556 (Recurrent disease)
    SNOMED
    58184002
    UMLS CUI [2,2]
    C0687676 (Post)
    SNOMED
    288563008
    LOINC
    LP20512-7
    UMLS CUI [2,3]
    C2193200 (Autologous haematopoietic stem cell transplant)
    eastern cooperative oncology group (ecog) performance status of 0-2.
    Description

    ECOG performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    age≥18.
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    pulse oximetry of > 90% on room air.
    Description

    Pulse Oximetry on room air

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0034108 (Oximetry, Pulse)
    SNOMED
    708065004
    UMLS CUI [1,2]
    C2709070 (on room air)
    LOINC
    LP93755-4
    adequate hepatic function, defined as alanine transaminase (alt) <3 x upper limit of normal (uln), aspartate aminotransferase (ast) <3 x uln; serum bilirubin and alkaline phosphatase <2 x uln.
    Description

    Liver function | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement | Alkaline phosphatase measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232741 (Liver function)
    SNOMED
    79036002
    LOINC
    LP31397-0
    UMLS CUI [2]
    C0201836 (Alanine aminotransferase measurement)
    SNOMED
    34608000
    UMLS CUI [3]
    C0201899 (Aspartate aminotransferase measurement)
    SNOMED
    45896001
    UMLS CUI [4]
    C1278039 (Serum total bilirubin measurement)
    SNOMED
    313840000
    UMLS CUI [5]
    C0201850 (Alkaline phosphatase measurement)
    SNOMED
    88810008
    adequate renal function, defined as serum creatinine <2.0mg/dl.
    Description

    Renal function | Creatinine measurement, serum

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232804 (Renal function)
    SNOMED
    11953005
    LOINC
    LP31398-8
    UMLS CUI [2]
    C0201976 (Creatinine measurement, serum (procedure))
    SNOMED
    113075003
    adequate heart function with lvef≥50%
    Description

    Cardiac function | Left ventricular ejection fraction

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232164 (Cardiac function)
    SNOMED
    86185002
    UMLS CUI [2]
    C0428772 (Left ventricular ejection fraction)
    SNOMED
    250908004
    hb≥80g/l
    Description

    Hemoglobin measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0518015 (Hemoglobin measurement)
    measurable disease can be identified.
    Description

    Measurable Disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1513041 (Measurable Disease)
    life expectancy ≥3 months.
    Description

    Life Expectancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023671 (Life Expectancy)
    sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 1 year after the study is concluded. the male partner should use a condom.
    Description

    Patients Sexually active Contraceptive methods | Gender Male Condoms

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705 (Patients)
    SNOMED
    116154003
    UMLS CUI [1,2]
    C0241028 (Sexually active)
    SNOMED
    228453005
    UMLS CUI [1,3]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    UMLS CUI [2,1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    UMLS CUI [2,2]
    C0009653 (Condoms, Male)
    SNOMED
    706506000
    patients must sign an informed consent.
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    uncontrolled active infection.
    Description

    Communicable Disease Uncontrolled

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450 (Communicable Diseases)
    SNOMED
    189822004
    UMLS CUI [1,2]
    C0205318 (Uncontrolled)
    SNOMED
    19032002
    active infection with hepatitis b virus (hbv), hepatitis c virus (hcv).
    Description

    Hepatitis B | Hepatitis C

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019163 (Hepatitis B)
    SNOMED
    66071002
    LOINC
    LA18126-5
    UMLS CUI [2]
    C0019196 (Hepatitis C)
    SNOMED
    50711007
    LOINC
    LA19423-5
    hiv positive
    Description

    HIV Seropositivity

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019699 (HIV Seropositivity)
    SNOMED
    165816005
    pregnant or lactating.
    Description

    Pregnancy | Breast Feeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    currently enrolled in another clinical trial.
    Description

    Study Subject Participation Status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)
    concurrent use of systemic steroids.
    Description

    Systemic steroids

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2825233 (systemic steroids)
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    Similar models

    Eligibility B-cell Lymphomas NCT02247609

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    B-cell lymphoma recurrent CD19 Positive Immunohistochemistry | B-cell lymphoma refractory CD19 Positive Immunohistochemistry | B-cell lymphoma recurrent CD19 Positive Flow Cytometry | B-cell lymphoma refractory CD19 Positive Flow Cytometry
    Item
    relapsed or refractory cd19(+) b cell lymphoma patients proved by immuno-histochemistry (ihc) or flow-cytometry.
    boolean
    C0855089 (UMLS CUI [1,1])
    C4289895 (UMLS CUI [1,2])
    C0021044 (UMLS CUI [1,3])
    C0855090 (UMLS CUI [2,1])
    C4289895 (UMLS CUI [2,2])
    C0021044 (UMLS CUI [2,3])
    C0855089 (UMLS CUI [3,1])
    C4289895 (UMLS CUI [3,2])
    C0016263 (UMLS CUI [3,3])
    C0855090 (UMLS CUI [4,1])
    C4289895 (UMLS CUI [4,2])
    C0016263 (UMLS CUI [4,3])
    Ineligibility Autologous hematopoietic stem cell transplant | Recurrent disease Post Autologous hematopoietic stem cell transplant
    Item
    not eligible for autologous stem-cell transplantation (asct) or relapsed after asct.
    boolean
    C1512714 (UMLS CUI [1,1])
    C2193200 (UMLS CUI [1,2])
    C0277556 (UMLS CUI [2,1])
    C0687676 (UMLS CUI [2,2])
    C2193200 (UMLS CUI [2,3])
    ECOG performance status
    Item
    eastern cooperative oncology group (ecog) performance status of 0-2.
    boolean
    C1520224 (UMLS CUI [1])
    Age
    Item
    age≥18.
    boolean
    C0001779 (UMLS CUI [1])
    Pulse Oximetry on room air
    Item
    pulse oximetry of > 90% on room air.
    boolean
    C0034108 (UMLS CUI [1,1])
    C2709070 (UMLS CUI [1,2])
    Liver function | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement | Alkaline phosphatase measurement
    Item
    adequate hepatic function, defined as alanine transaminase (alt) <3 x upper limit of normal (uln), aspartate aminotransferase (ast) <3 x uln; serum bilirubin and alkaline phosphatase <2 x uln.
    boolean
    C0232741 (UMLS CUI [1])
    C0201836 (UMLS CUI [2])
    C0201899 (UMLS CUI [3])
    C1278039 (UMLS CUI [4])
    C0201850 (UMLS CUI [5])
    Renal function | Creatinine measurement, serum
    Item
    adequate renal function, defined as serum creatinine <2.0mg/dl.
    boolean
    C0232804 (UMLS CUI [1])
    C0201976 (UMLS CUI [2])
    Cardiac function | Left ventricular ejection fraction
    Item
    adequate heart function with lvef≥50%
    boolean
    C0232164 (UMLS CUI [1])
    C0428772 (UMLS CUI [2])
    Hemoglobin measurement
    Item
    hb≥80g/l
    boolean
    C0518015 (UMLS CUI [1])
    Measurable Disease
    Item
    measurable disease can be identified.
    boolean
    C1513041 (UMLS CUI [1])
    Life Expectancy
    Item
    life expectancy ≥3 months.
    boolean
    C0023671 (UMLS CUI [1])
    Patients Sexually active Contraceptive methods | Gender Male Condoms
    Item
    sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 1 year after the study is concluded. the male partner should use a condom.
    boolean
    C0030705 (UMLS CUI [1,1])
    C0241028 (UMLS CUI [1,2])
    C0700589 (UMLS CUI [1,3])
    C0079399 (UMLS CUI [2,1])
    C0009653 (UMLS CUI [2,2])
    Informed Consent
    Item
    patients must sign an informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Communicable Disease Uncontrolled
    Item
    uncontrolled active infection.
    boolean
    C0009450 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    Hepatitis B | Hepatitis C
    Item
    active infection with hepatitis b virus (hbv), hepatitis c virus (hcv).
    boolean
    C0019163 (UMLS CUI [1])
    C0019196 (UMLS CUI [2])
    HIV Seropositivity
    Item
    hiv positive
    boolean
    C0019699 (UMLS CUI [1])
    Pregnancy | Breast Feeding
    Item
    pregnant or lactating.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Study Subject Participation Status
    Item
    currently enrolled in another clinical trial.
    boolean
    C2348568 (UMLS CUI [1])
    Systemic steroids
    Item
    concurrent use of systemic steroids.
    boolean
    C2825233 (UMLS CUI [1])
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