ID

28073

Descrição

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

Palavras-chave

Versões (1)
  1. 14/12/2017 14/12/2017 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

14 de dezembro de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Chronic Lymphocytic Leukemia NCT01013441

Inglês

Eligibility Chronic Lymphocytic Leukemia NCT01013441

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

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

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

Tipo de dados

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
Descrição

Rai Staging System

Tipo de dados

boolean

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

Zubrod Performance Status

Tipo de dados

boolean

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

fludarabine | alemtuzumab

Tipo de dados

boolean

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

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

Tipo de dados

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
Descrição

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods

Tipo de dados

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
Descrição

CNS disorder Absent

Tipo de dados

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.
Descrição

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

Tipo de dados

boolean

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

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
Descrição

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

Tipo de dados

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.
Descrição

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

Tipo de dados

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
Descrição

Immune thrombocytopenic purpura | Autoimmune hemolytic anemia

Tipo de dados

boolean

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

Eligibility Chronic Lymphocytic Leukemia NCT01013441

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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