ID

30394

Beschrijving

SAR3419 Administered Weekly in Patients With Relapsed/Refractory CD19-positive B-cell Non-Hodgkin's Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00796731

Link

https://clinicaltrials.gov/show/NCT00796731

Trefwoorden

Versies (1)
  1. 01-06-18 01-06-18 -
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See clinicaltrials.gov

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1 juni 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Lymphoma NCT00796731

Engels

Eligibility Lymphoma NCT00796731

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00796731
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of b-cell non hodgkin's lymphoma
Beschrijving

B-Cell Lymphomas

Datatype

boolean

Alias
UMLS CUI [1]
C0079731
relapsed or refractory after standard treatments and with no curative option with conventional therapy (patients having undergone stem cell transplantation may be included)
Beschrijving

Recurrent disease | Refractory Disease | Status post Standard of Care | Absence Conventional Treatment Curative | Stem cell transplant

Datatype

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C1514815
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C2936643
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C2945704
UMLS CUI [4,3]
C1276305
UMLS CUI [5]
C1504389
cd19 positive disease by flow cytometry or immunohistochemistry
Beschrijving

Disease CD19 positive Flow Cytometry | Disease CD19 positive Immunohistochemistry

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0882808
UMLS CUI [1,3]
C0016263
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0882808
UMLS CUI [2,3]
C0021044
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
burkitt's lymphoma, lymphoblastic lymphoma, chronic lymphocytic leukemia (small lymphocytic lymphoma may be included)
Beschrijving

Burkitt Lymphoma | Lymphoblastic lymphoma | Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma

Datatype

boolean

Alias
UMLS CUI [1]
C0006413
UMLS CUI [2]
C0079748
UMLS CUI [3]
C0023434
UMLS CUI [4]
C0855095
evidence of cerebral or meningeal involvement by lymphoma
Beschrijving

Involvement cerebral Lymphoma | Involvement meningeal Lymphoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C1314939
UMLS CUI [1,2]
C0006104
UMLS CUI [1,3]
C0024299
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C0521400
UMLS CUI [2,3]
C0024299
patients without bi-dimensionally measurable disease
Beschrijving

Absence Measurable Disease 2-Dimensional

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1513041
UMLS CUI [1,3]
C1705052
ecog performance status > 2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy less than 3 months
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
chemotherapy or radiation therapy or other investigational agents within 4 weeks prior to entering the study
Beschrijving

Chemotherapy | Therapeutic radiology procedure | Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0013230
previous radioimmunotherapy within 12 weeks
Beschrijving

Radioimmunotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0085101
known anaphylaxis to infused proteins
Beschrijving

Anaphylaxis Protein Infusion

Datatype

boolean

Alias
UMLS CUI [1,1]
C0002792
UMLS CUI [1,2]
C0033684
UMLS CUI [1,3]
C1827465
hiv, hbv and hcv positivity
Beschrijving

HIV Seropositivity | Hepatitis B positive | Hepatitis C positive

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0856706
UMLS CUI [3]
C1112419
poor kidney, liver and bone marrow functions
Beschrijving

Renal function Poor | Liver function Poor | Bone Marrow function Poor

Datatype

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0542537
UMLS CUI [2,1]
C0232741
UMLS CUI [2,2]
C0542537
UMLS CUI [3,1]
C0005953
UMLS CUI [3,2]
C0031843
UMLS CUI [3,3]
C0542537
any serious active disease or co-morbid condition, which, in the opinion of the principle investigator, will interfere with the safety or the compliance with the study
Beschrijving

Disease Serious Interferes with Safety | Comorbidity Interferes with Safety | Disease Serious Interferes with Protocol Compliance | Comorbidity Interferes with Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0036043
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0036043
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C0525058
UMLS CUI [4,1]
C0009488
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0525058
pregnant or breast-feeding women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients with reproductive potential without effective birth control methods
Beschrijving

Females & males of reproductive potential Contraceptive methods Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Beschrijving

Study Subject Participation Status | Eligibility Criteria Additional

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1516637
UMLS CUI [2,2]
C1524062
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Similar models

Eligibility Lymphoma NCT00796731

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00796731
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
B-Cell Lymphomas
Item
diagnosis of b-cell non hodgkin's lymphoma
boolean
C0079731 (UMLS CUI [1])
Recurrent disease | Refractory Disease | Status post Standard of Care | Absence Conventional Treatment Curative | Stem cell transplant
Item
relapsed or refractory after standard treatments and with no curative option with conventional therapy (patients having undergone stem cell transplantation may be included)
boolean
C0277556 (UMLS CUI [1])
C1514815 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C2936643 (UMLS CUI [3,2])
C0332197 (UMLS CUI [4,1])
C2945704 (UMLS CUI [4,2])
C1276305 (UMLS CUI [4,3])
C1504389 (UMLS CUI [5])
Disease CD19 positive Flow Cytometry | Disease CD19 positive Immunohistochemistry
Item
cd19 positive disease by flow cytometry or immunohistochemistry
boolean
C0012634 (UMLS CUI [1,1])
C0882808 (UMLS CUI [1,2])
C0016263 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0882808 (UMLS CUI [2,2])
C0021044 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Burkitt Lymphoma | Lymphoblastic lymphoma | Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma
Item
burkitt's lymphoma, lymphoblastic lymphoma, chronic lymphocytic leukemia (small lymphocytic lymphoma may be included)
boolean
C0006413 (UMLS CUI [1])
C0079748 (UMLS CUI [2])
C0023434 (UMLS CUI [3])
C0855095 (UMLS CUI [4])
Involvement cerebral Lymphoma | Involvement meningeal Lymphoma
Item
evidence of cerebral or meningeal involvement by lymphoma
boolean
C1314939 (UMLS CUI [1,1])
C0006104 (UMLS CUI [1,2])
C0024299 (UMLS CUI [1,3])
C1314939 (UMLS CUI [2,1])
C0521400 (UMLS CUI [2,2])
C0024299 (UMLS CUI [2,3])
Absence Measurable Disease 2-Dimensional
Item
patients without bi-dimensionally measurable disease
boolean
C0332197 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
C1705052 (UMLS CUI [1,3])
ECOG performance status
Item
ecog performance status > 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy less than 3 months
boolean
C0023671 (UMLS CUI [1])
Chemotherapy | Therapeutic radiology procedure | Investigational New Drugs
Item
chemotherapy or radiation therapy or other investigational agents within 4 weeks prior to entering the study
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Radioimmunotherapy
Item
previous radioimmunotherapy within 12 weeks
boolean
C0085101 (UMLS CUI [1])
Anaphylaxis Protein Infusion
Item
known anaphylaxis to infused proteins
boolean
C0002792 (UMLS CUI [1,1])
C0033684 (UMLS CUI [1,2])
C1827465 (UMLS CUI [1,3])
HIV Seropositivity | Hepatitis B positive | Hepatitis C positive
Item
hiv, hbv and hcv positivity
boolean
C0019699 (UMLS CUI [1])
C0856706 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
Renal function Poor | Liver function Poor | Bone Marrow function Poor
Item
poor kidney, liver and bone marrow functions
boolean
C0232804 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2,1])
C0542537 (UMLS CUI [2,2])
C0005953 (UMLS CUI [3,1])
C0031843 (UMLS CUI [3,2])
C0542537 (UMLS CUI [3,3])
Disease Serious Interferes with Safety | Comorbidity Interferes with Safety | Disease Serious Interferes with Protocol Compliance | Comorbidity Interferes with Protocol Compliance
Item
any serious active disease or co-morbid condition, which, in the opinion of the principle investigator, will interfere with the safety or the compliance with the study
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0036043 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0036043 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0525058 (UMLS CUI [3,4])
C0009488 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Females & males of reproductive potential Contraceptive methods Absent
Item
patients with reproductive potential without effective birth control methods
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Study Subject Participation Status | Eligibility Criteria Additional
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])
C1516637 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
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