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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

Lien

https://clinicaltrials.gov/show/NCT02247609

Mots-clés

Versions (1)
  1. 16/08/2019 16/08/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

16 août 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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    Eligibility B-cell Lymphomas NCT02247609

    Anglais

    Eligibility B-cell Lymphomas NCT02247609

    1 Formulaires  
    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

    Type de données

    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

    Type de données

    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

    Type de données

    boolean

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

    Age

    Type de données

    boolean

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

    Pulse Oximetry on room air

    Type de données

    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

    Type de données

    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

    Type de données

    boolean

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

    Cardiac function | Left ventricular ejection fraction

    Type de données

    boolean

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

    Hemoglobin measurement

    Type de données

    boolean

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

    Measurable Disease

    Type de données

    boolean

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

    Life Expectancy

    Type de données

    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

    Type de données

    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

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    uncontrolled active infection.
    Description

    Communicable Disease Uncontrolled

    Type de données

    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

    Type de données

    boolean

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

    HIV Seropositivity

    Type de données

    boolean

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

    Pregnancy | Breast Feeding

    Type de données

    boolean

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

    Study Subject Participation Status

    Type de données

    boolean

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

    Systemic steroids

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2825233
    Retour au début de la page

    Similar models

    Eligibility B-cell Lymphomas NCT02247609

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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])
    Retour au début de la page 

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