ID

30391

Beskrivning

Epstein-Barr Virus (EBV)-Specific T Cells as Therapy for Relapsed/Refractory EBV-positive Lymphomas; ODM derived from: https://clinicaltrials.gov/show/NCT00779337

Länk

https://clinicaltrials.gov/show/NCT00779337

Nyckelord

Versioner (1)
  1. 2018-06-01 2018-06-01 -
Rättsinnehavare

See clinicaltrials.gov

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1 juni 2018

DOI

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Creative Commons BY 4.0
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Eligibility Lymphoma NCT00779337

Engelsk

Eligibility Lymphoma NCT00779337

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00779337
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
ebv-positive lymphoma as determined by in situ hybridization or equivalent (excluding burkitts lymphoma).
Beskrivning

Lymphoma Epstein-Barr Virus Positive In Situ Hybridization | In Situ Hybridization Equivalent | Burkitt Lymphoma Excluded

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0014644
UMLS CUI [1,3]
C1514241
UMLS CUI [1,4]
C0162788
UMLS CUI [2,1]
C0162788
UMLS CUI [2,2]
C0205163
UMLS CUI [3,1]
C0006413
UMLS CUI [3,2]
C0332196
age 18 years or older.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status 1, 2 or 3
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of at least 6 months.
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
measurable disease: either relapsing, partially responsive, refractory or progressive disease, includes disease detected either by clinical examination, radiographic evaluation (including ct scans, and at physician's discretion by functional imaging), or a persistently detectable plasma ebv viral load.
Beskrivning

Measurable Disease | Recurrent disease | Partial response | Refractory Disease | Progressive Disease | Measurable Disease Clinical examination | Measurable Disease Radiography | Measurable Disease CT scan | Measurable Disease Functional Imaging | Plasma EBV Viral load Persistent

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C0277556
UMLS CUI [3]
C1521726
UMLS CUI [4]
C1514815
UMLS CUI [5]
C1335499
UMLS CUI [6,1]
C1513041
UMLS CUI [6,2]
C1456356
UMLS CUI [7,1]
C1513041
UMLS CUI [7,2]
C0034571
UMLS CUI [8,1]
C1513041
UMLS CUI [8,2]
C0040405
UMLS CUI [9,1]
C1513041
UMLS CUI [9,2]
C1517324
UMLS CUI [10,1]
C0032105
UMLS CUI [10,2]
C0014644
UMLS CUI [10,3]
C0376705
UMLS CUI [10,4]
C0205322
no chemotherapy / radiotherapy and/or antibody therapy for at least 2 weeks prior to anticipated date of first infusion.
Beskrivning

Chemotherapy Absent | Therapeutic radiology procedure Absent | Antibody therapy Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0281176
UMLS CUI [3,2]
C0332197
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
ebv negative tumour
Beskrivning

Neoplasm Epstein-Barr Virus Negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0014644
UMLS CUI [1,3]
C1513916
presence of detectable malignant cells in the peripheral circulation by flow cytometry or morphology
Beskrivning

Malignant cells Detectable Peripheral circulation Flow Cytometry | Malignant cells Detectable Peripheral circulation Morphanalysis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0334227
UMLS CUI [1,2]
C3830527
UMLS CUI [1,3]
C0425710
UMLS CUI [1,4]
C0016263
UMLS CUI [2,1]
C0334227
UMLS CUI [2,2]
C3830527
UMLS CUI [2,3]
C0425710
UMLS CUI [2,4]
C0411862
serious infection within the past 28 days that has not adequately responded to therapy
Beskrivning

Communicable Disease Serious | Disease Response Inadequate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0205412
pregnancy, or unwilling to use adequate contraception
Beskrivning

Pregnancy | Contraceptive methods Unwilling

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0558080
serology (taken within 3 months of ctl release date) indicating active hbv or hcv infection, positive serology for hiv i&ii, htlv1 or syphilis
Beskrivning

Serology positive Hepatitis B | Serology positive Hepatitis C | Serology positive HIV-1 | Serology positive HIV-2 | Serology positive Syphilis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242089
UMLS CUI [1,2]
C0019163
UMLS CUI [2,1]
C0242089
UMLS CUI [2,2]
C0019196
UMLS CUI [3,1]
C0242089
UMLS CUI [3,2]
C0019704
UMLS CUI [4,1]
C0242089
UMLS CUI [4,2]
C0019707
UMLS CUI [5,1]
C0242089
UMLS CUI [5,2]
C0039128
negative serology for ebv
Beskrivning

Serology negative Epstein-Barr Virus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0919674
UMLS CUI [1,2]
C0014644
psychiatric, addictive or any condition which may compromise the ability to participate in this trial
Beskrivning

Mental condition compromises Study Subject Participation Status | Addictive Behavior compromises Study Subject Participation Status | Condition compromises Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0085281
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C2348568
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Similar models

Eligibility Lymphoma NCT00779337

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00779337
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
informed consent.
boolean
C0021430 (UMLS CUI [1])
Lymphoma Epstein-Barr Virus Positive In Situ Hybridization | In Situ Hybridization Equivalent | Burkitt Lymphoma Excluded
Item
ebv-positive lymphoma as determined by in situ hybridization or equivalent (excluding burkitts lymphoma).
boolean
C0024299 (UMLS CUI [1,1])
C0014644 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C0162788 (UMLS CUI [1,4])
C0162788 (UMLS CUI [2,1])
C0205163 (UMLS CUI [2,2])
C0006413 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
Age
Item
age 18 years or older.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 1, 2 or 3
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of at least 6 months.
boolean
C0023671 (UMLS CUI [1])
Measurable Disease | Recurrent disease | Partial response | Refractory Disease | Progressive Disease | Measurable Disease Clinical examination | Measurable Disease Radiography | Measurable Disease CT scan | Measurable Disease Functional Imaging | Plasma EBV Viral load Persistent
Item
measurable disease: either relapsing, partially responsive, refractory or progressive disease, includes disease detected either by clinical examination, radiographic evaluation (including ct scans, and at physician's discretion by functional imaging), or a persistently detectable plasma ebv viral load.
boolean
C1513041 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C1521726 (UMLS CUI [3])
C1514815 (UMLS CUI [4])
C1335499 (UMLS CUI [5])
C1513041 (UMLS CUI [6,1])
C1456356 (UMLS CUI [6,2])
C1513041 (UMLS CUI [7,1])
C0034571 (UMLS CUI [7,2])
C1513041 (UMLS CUI [8,1])
C0040405 (UMLS CUI [8,2])
C1513041 (UMLS CUI [9,1])
C1517324 (UMLS CUI [9,2])
C0032105 (UMLS CUI [10,1])
C0014644 (UMLS CUI [10,2])
C0376705 (UMLS CUI [10,3])
C0205322 (UMLS CUI [10,4])
Chemotherapy Absent | Therapeutic radiology procedure Absent | Antibody therapy Absent
Item
no chemotherapy / radiotherapy and/or antibody therapy for at least 2 weeks prior to anticipated date of first infusion.
boolean
C0392920 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0281176 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Neoplasm Epstein-Barr Virus Negative
Item
ebv negative tumour
boolean
C0027651 (UMLS CUI [1,1])
C0014644 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
Malignant cells Detectable Peripheral circulation Flow Cytometry | Malignant cells Detectable Peripheral circulation Morphanalysis
Item
presence of detectable malignant cells in the peripheral circulation by flow cytometry or morphology
boolean
C0334227 (UMLS CUI [1,1])
C3830527 (UMLS CUI [1,2])
C0425710 (UMLS CUI [1,3])
C0016263 (UMLS CUI [1,4])
C0334227 (UMLS CUI [2,1])
C3830527 (UMLS CUI [2,2])
C0425710 (UMLS CUI [2,3])
C0411862 (UMLS CUI [2,4])
Communicable Disease Serious | Disease Response Inadequate
Item
serious infection within the past 28 days that has not adequately responded to therapy
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1704632 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
Pregnancy | Contraceptive methods Unwilling
Item
pregnancy, or unwilling to use adequate contraception
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Serology positive Hepatitis B | Serology positive Hepatitis C | Serology positive HIV-1 | Serology positive HIV-2 | Serology positive Syphilis
Item
serology (taken within 3 months of ctl release date) indicating active hbv or hcv infection, positive serology for hiv i&ii, htlv1 or syphilis
boolean
C0242089 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C0242089 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C0242089 (UMLS CUI [3,1])
C0019704 (UMLS CUI [3,2])
C0242089 (UMLS CUI [4,1])
C0019707 (UMLS CUI [4,2])
C0242089 (UMLS CUI [5,1])
C0039128 (UMLS CUI [5,2])
Serology negative Epstein-Barr Virus
Item
negative serology for ebv
boolean
C0919674 (UMLS CUI [1,1])
C0014644 (UMLS CUI [1,2])
Mental condition compromises Study Subject Participation Status | Addictive Behavior compromises Study Subject Participation Status | Condition compromises Study Subject Participation Status
Item
psychiatric, addictive or any condition which may compromise the ability to participate in this trial
boolean
C3840291 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0085281 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
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