0 Ratings
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 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 16, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

    No comments

    In order to download data models you must be logged in. Please log in or register for free.

    Eligibility B-cell Lymphomas NCT02247609

    English

    Eligibility B-cell Lymphomas NCT02247609

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    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
    UMLS CUI [1,2]
    C4289895
    UMLS CUI [1,3]
    C0021044
    UMLS CUI [2,1]
    C0855090
    UMLS CUI [2,2]
    C4289895
    UMLS CUI [2,3]
    C0021044
    UMLS CUI [3,1]
    C0855089
    UMLS CUI [3,2]
    C4289895
    UMLS CUI [3,3]
    C0016263
    UMLS CUI [4,1]
    C0855090
    UMLS CUI [4,2]
    C4289895
    UMLS CUI [4,3]
    C0016263
    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
    UMLS CUI [1,2]
    C2193200
    UMLS CUI [2,1]
    C0277556
    UMLS CUI [2,2]
    C0687676
    UMLS CUI [2,3]
    C2193200
    eastern cooperative oncology group (ecog) performance status of 0-2.
    Description

    ECOG performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    age≥18.
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    pulse oximetry of > 90% on room air.
    Description

    Pulse Oximetry on room air

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0034108
    UMLS CUI [1,2]
    C2709070
    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
    UMLS CUI [2]
    C0201836
    UMLS CUI [3]
    C0201899
    UMLS CUI [4]
    C1278039
    UMLS CUI [5]
    C0201850
    adequate renal function, defined as serum creatinine <2.0mg/dl.
    Description

    Renal function | Creatinine measurement, serum

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232804
    UMLS CUI [2]
    C0201976
    adequate heart function with lvef≥50%
    Description

    Cardiac function | Left ventricular ejection fraction

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232164
    UMLS CUI [2]
    C0428772
    hb≥80g/l
    Description

    Hemoglobin measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0518015
    measurable disease can be identified.
    Description

    Measurable Disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1513041
    life expectancy ≥3 months.
    Description

    Life Expectancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    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
    UMLS CUI [1,2]
    C0241028
    UMLS CUI [1,3]
    C0700589
    UMLS CUI [2,1]
    C0079399
    UMLS CUI [2,2]
    C0009653
    patients must sign an informed consent.
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    uncontrolled active infection.
    Description

    Communicable Disease Uncontrolled

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0205318
    active infection with hepatitis b virus (hbv), hepatitis c virus (hcv).
    Description

    Hepatitis B | Hepatitis C

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019163
    UMLS CUI [2]
    C0019196
    hiv positive
    Description

    HIV Seropositivity

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019699
    pregnant or lactating.
    Description

    Pregnancy | Breast Feeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    currently enrolled in another clinical trial.
    Description

    Study Subject Participation Status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    concurrent use of systemic steroids.
    Description

    Systemic steroids

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2825233
    Back to the top of the page

    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])
    Back to the top of the page 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial