ID

28073

Beschrijving

CD3/CD28 Bead Activated T-Cells Following Chemo-Immunotherapy in Patients With Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01013441

Link

https://clinicaltrials.gov/show/NCT01013441

Trefwoorden

  1. 14-12-17 14-12-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

14 december 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Chronic Lymphocytic Leukemia NCT01013441

Eligibility Chronic Lymphocytic Leukemia NCT01013441

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of cll by immunophenotyping and flow cytometry analysis of blood or bone marrow.
Beschrijving

CLL Immunophenotyping | CLL Blood Flow Cytometry | CLL Bone Marrow Flow Cytometry

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023434
UMLS CUI [1,2]
C0079611
UMLS CUI [2,1]
C0023434
UMLS CUI [2,2]
C1511221
UMLS CUI [3,1]
C0023434
UMLS CUI [3,2]
C1511242
patients with rai stage iii-iv - or - patients with rai stage 0-ii
Beschrijving

Rai Staging System

Datatype

boolean

Alias
UMLS CUI [1]
C1514715
zubrod performance status of 0-3
Beschrijving

Zubrod Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C3714786
prior treatment with fludarabine or alemtuzumab based regimens.
Beschrijving

fludarabine | alemtuzumab

Datatype

boolean

Alias
UMLS CUI [1]
C0059985
UMLS CUI [2]
C0383429
no untreated or uncontrolled life-threatening infection
Beschrijving

Absence Communicable Disease Life Threatening untreated | Absence Communicable Disease Life Threatening Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0009450
UMLS CUI [1,3]
C2826244
UMLS CUI [1,4]
C0332155
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0009450
UMLS CUI [2,3]
C2826244
UMLS CUI [2,4]
C0205318
women of childbearing potential must have a negative serum pregnancy test and agree to use a medically accepted form of contraception from the time of initial screening through completion of the study
Beschrijving

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
no active cns disease
Beschrijving

CNS disorder Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007682
UMLS CUI [1,2]
C0332197
negative tests for hiv antibodies, hepatitis b surface antigen, and hepatitis c antibodies.
Beschrijving

HIV antibody negative | Hepatitis B surface antigen negative | Hepatitis C antibody negative

Datatype

boolean

Alias
UMLS CUI [1]
C1142096
UMLS CUI [2]
C0919711
UMLS CUI [3]
C0853904
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
receipt of glucocorticoids (with the exception of inhaled glucocorticoid steroids for the use of allergic rhinitis or pulmonary disease) within 2 months prior to registration
Beschrijving

Glucocorticoids | Exception Glucocorticoids Inhalation Allergic rhinitis | Exception Glucocorticoids Inhalation Lung disease

Datatype

boolean

Alias
UMLS CUI [1]
C0017710
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0017710
UMLS CUI [2,3]
C0205535
UMLS CUI [2,4]
C2607914
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0017710
UMLS CUI [3,3]
C0205535
UMLS CUI [3,4]
C0024115
history of autoimmune disease unrelated to cll (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis). autoimmune disease related to cll, e.g.
Beschrijving

Autoimmune Diseases Independent of CLL | Rheumatoid Arthritis | Multiple Sclerosis | Lupus Erythematosus, Systemic | Autoimmune Disease Relationship CLL

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C0332291
UMLS CUI [1,3]
C0023434
UMLS CUI [2]
C0003873
UMLS CUI [3]
C0026769
UMLS CUI [4]
C0024141
UMLS CUI [5,1]
C0004364
UMLS CUI [5,2]
C0439849
UMLS CUI [5,3]
C0023434
idiopathic thrombocytopenic purpura (itp) or autoimmune hemolytic anemia, is permitted if not requiring active treatment
Beschrijving

Immune thrombocytopenic purpura | Autoimmune hemolytic anemia

Datatype

boolean

Alias
UMLS CUI [1]
C0398650
UMLS CUI [2]
C0002880

Similar models

Eligibility Chronic Lymphocytic Leukemia NCT01013441

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
CLL Immunophenotyping | CLL Blood Flow Cytometry | CLL Bone Marrow Flow Cytometry
Item
diagnosis of cll by immunophenotyping and flow cytometry analysis of blood or bone marrow.
boolean
C0023434 (UMLS CUI [1,1])
C0079611 (UMLS CUI [1,2])
C0023434 (UMLS CUI [2,1])
C1511221 (UMLS CUI [2,2])
C0023434 (UMLS CUI [3,1])
C1511242 (UMLS CUI [3,2])
Rai Staging System
Item
patients with rai stage iii-iv - or - patients with rai stage 0-ii
boolean
C1514715 (UMLS CUI [1])
Zubrod Performance Status
Item
zubrod performance status of 0-3
boolean
C3714786 (UMLS CUI [1])
fludarabine | alemtuzumab
Item
prior treatment with fludarabine or alemtuzumab based regimens.
boolean
C0059985 (UMLS CUI [1])
C0383429 (UMLS CUI [2])
Absence Communicable Disease Life Threatening untreated | Absence Communicable Disease Life Threatening Uncontrolled
Item
no untreated or uncontrolled life-threatening infection
boolean
C0332197 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
C2826244 (UMLS CUI [1,3])
C0332155 (UMLS CUI [1,4])
C0332197 (UMLS CUI [2,1])
C0009450 (UMLS CUI [2,2])
C2826244 (UMLS CUI [2,3])
C0205318 (UMLS CUI [2,4])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods
Item
women of childbearing potential must have a negative serum pregnancy test and agree to use a medically accepted form of contraception from the time of initial screening through completion of the study
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
CNS disorder Absent
Item
no active cns disease
boolean
C0007682 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
HIV antibody negative | Hepatitis B surface antigen negative | Hepatitis C antibody negative
Item
negative tests for hiv antibodies, hepatitis b surface antigen, and hepatitis c antibodies.
boolean
C1142096 (UMLS CUI [1])
C0919711 (UMLS CUI [2])
C0853904 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Glucocorticoids | Exception Glucocorticoids Inhalation Allergic rhinitis | Exception Glucocorticoids Inhalation Lung disease
Item
receipt of glucocorticoids (with the exception of inhaled glucocorticoid steroids for the use of allergic rhinitis or pulmonary disease) within 2 months prior to registration
boolean
C0017710 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0017710 (UMLS CUI [2,2])
C0205535 (UMLS CUI [2,3])
C2607914 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0017710 (UMLS CUI [3,2])
C0205535 (UMLS CUI [3,3])
C0024115 (UMLS CUI [3,4])
Autoimmune Diseases Independent of CLL | Rheumatoid Arthritis | Multiple Sclerosis | Lupus Erythematosus, Systemic | Autoimmune Disease Relationship CLL
Item
history of autoimmune disease unrelated to cll (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis). autoimmune disease related to cll, e.g.
boolean
C0004364 (UMLS CUI [1,1])
C0332291 (UMLS CUI [1,2])
C0023434 (UMLS CUI [1,3])
C0003873 (UMLS CUI [2])
C0026769 (UMLS CUI [3])
C0024141 (UMLS CUI [4])
C0004364 (UMLS CUI [5,1])
C0439849 (UMLS CUI [5,2])
C0023434 (UMLS CUI [5,3])
Immune thrombocytopenic purpura | Autoimmune hemolytic anemia
Item
idiopathic thrombocytopenic purpura (itp) or autoimmune hemolytic anemia, is permitted if not requiring active treatment
boolean
C0398650 (UMLS CUI [1])
C0002880 (UMLS CUI [2])

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