ID

37690

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02247609

Nyckelord

Versioner (1)
  1. 2019-08-16 2019-08-16 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

16 augusti 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility B-cell Lymphomas NCT02247609

Engelsk

Eligibility B-cell Lymphomas NCT02247609

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

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

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

ECOG performance status

Datatyp

boolean

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

Age

Datatyp

boolean

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

Pulse Oximetry on room air

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Renal function | Creatinine measurement, serum

Datatyp

boolean

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

Cardiac function | Left ventricular ejection fraction

Datatyp

boolean

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

Hemoglobin measurement

Datatyp

boolean

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

Measurable Disease

Datatyp

boolean

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

Life Expectancy

Datatyp

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.
Beskrivning

Patients Sexually active Contraceptive methods | Gender Male Condoms

Datatyp

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.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
uncontrolled active infection.
Beskrivning

Communicable Disease Uncontrolled

Datatyp

boolean

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

Hepatitis B | Hepatitis C

Datatyp

boolean

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

HIV Seropositivity

Datatyp

boolean

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

Pregnancy | Breast Feeding

Datatyp

boolean

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

Study Subject Participation Status

Datatyp

boolean

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

Systemic steroids

Datatyp

boolean

Alias
UMLS CUI [1]
C2825233
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Similar models

Eligibility B-cell Lymphomas NCT02247609

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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