ID

36318

Beschrijving

CAR T Cells Targeting CD30 Positive Lymphomas (4SCAR30273); ODM derived from: https://clinicaltrials.gov/show/NCT02274584

Link

https://clinicaltrials.gov/show/NCT02274584

Trefwoorden

Versies (1)
  1. 03-05-19 03-05-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

3 mei 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Lymphomas NCT02274584

Engels

Eligibility Lymphomas NCT02274584

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphomas NCT02274584
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
relapsed or refractory cd30(+) lymphoma patients proved by immuno-histochemistry (ihc) or flow-cytometry.
Beschrijving

Recurrent Lymphoma CD30 positive Immunohistochemistry | Refractory Lymphoma CD30 positive Immunohistochemistry | Recurrent Lymphoma CD30 positive Flow Cytometry | Refractory Lymphoma CD30 positive Flow Cytometry

Datatype

boolean

Alias
UMLS CUI [1,1]
C4525062
UMLS CUI [1,2]
C3888910
UMLS CUI [1,3]
C0021044
UMLS CUI [2,1]
C4525060
UMLS CUI [2,2]
C3888910
UMLS CUI [2,3]
C0021044
UMLS CUI [3,1]
C4525062
UMLS CUI [3,2]
C3888910
UMLS CUI [3,3]
C0016263
UMLS CUI [4,1]
C4525060
UMLS CUI [4,2]
C3888910
UMLS CUI [4,3]
C0016263
not eligible for autologous stem-cell transplantation (asct) or relapsed after asct.
Beschrijving

Patient Ineligible Transplantation of autologous hematopoietic stem cell | Recurrent disease Post Transplantation of autologous hematopoietic stem cell

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1512714
UMLS CUI [1,3]
C1831743
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C1831743
eastern cooperative oncology group (ecog) performance status of 0-2.
Beschrijving

ECOG performance status

Datatype

boolean

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

Age

Datatype

boolean

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

Pulse Oximetry on room air

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

Renal function | Creatinine measurement, serum

Datatype

boolean

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

Cardiac function | Left ventricular ejection fraction

Datatype

boolean

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

Hemoglobin measurement

Datatype

boolean

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

Measurable Disease

Datatype

boolean

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

Life Expectancy

Datatype

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.
Beschrijving

Patients Sexually active Contraceptive methods | Partner Gender Condom use

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0700589
UMLS CUI [2,1]
C0682323
UMLS CUI [2,2]
C0079399
UMLS CUI [2,3]
C0679782
patients must sign an informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
uncontrolled active infection.
Beschrijving

Communicable Disease Uncontrolled

Datatype

boolean

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

Hepatitis B | Hepatitis C

Datatype

boolean

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

HIV Seropositivity

Datatype

boolean

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

Pregnancy | Breast Feeding

Datatype

boolean

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

Study Subject Participation Status

Datatype

boolean

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

Systemic steroids

Datatype

boolean

Alias
UMLS CUI [1]
C2825233
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Similar models

Eligibility Lymphomas NCT02274584

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Lymphomas NCT02274584
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Recurrent Lymphoma CD30 positive Immunohistochemistry | Refractory Lymphoma CD30 positive Immunohistochemistry | Recurrent Lymphoma CD30 positive Flow Cytometry | Refractory Lymphoma CD30 positive Flow Cytometry
Item
relapsed or refractory cd30(+) lymphoma patients proved by immuno-histochemistry (ihc) or flow-cytometry.
boolean
C4525062 (UMLS CUI [1,1])
C3888910 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C4525060 (UMLS CUI [2,1])
C3888910 (UMLS CUI [2,2])
C0021044 (UMLS CUI [2,3])
C4525062 (UMLS CUI [3,1])
C3888910 (UMLS CUI [3,2])
C0016263 (UMLS CUI [3,3])
C4525060 (UMLS CUI [4,1])
C3888910 (UMLS CUI [4,2])
C0016263 (UMLS CUI [4,3])
Patient Ineligible Transplantation of autologous hematopoietic stem cell | Recurrent disease Post Transplantation of autologous hematopoietic stem cell
Item
not eligible for autologous stem-cell transplantation (asct) or relapsed after asct.
boolean
C0030705 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
C1831743 (UMLS CUI [1,3])
C0277556 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C1831743 (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 | Partner Gender Condom use
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])
C0682323 (UMLS CUI [2,1])
C0079399 (UMLS CUI [2,2])
C0679782 (UMLS CUI [2,3])
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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