ID

36264

Descrição

A Clinical Research of CAR T Cells Targeting CD19 Positive Malignant B-cell Derived Leukemia and Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT02349698

Link

https://clinicaltrials.gov/show/NCT02349698

Palavras-chave

Versões (1)
  1. 25/04/2019 25/04/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

25 de abril de 2019

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Leukemia NCT02349698

Inglês

Eligibility Leukemia NCT02349698

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02349698
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. relapsed or refractory b cell derived acute lymphoblastic leukemia(all), chronic lymphoblastic leukemia(cll) and non-hodgkin lymphoma.
Descrição

Adult B Acute Lymphoblastic Leukemia Recurrent | Adult B Acute Lymphoblastic Leukemia Refractory | Chronic Lymphocytic Leukemia | Lymphoma, Non-Hodgkin

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0279593
UMLS CUI [1,2]
C2945760
UMLS CUI [2,1]
C0279593
UMLS CUI [2,2]
C0205269
UMLS CUI [3]
C0023434
UMLS CUI [4]
C0024305
2. kps>60.
Descrição

Karnofsky Performance Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0206065
3. life expectancy>3 months.
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
4. gender unlimited, age from 18 years to 70 years.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
5. disease progresses but reserves reaction to recent treatments.
Descrição

Disease Progression

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0242656
6. patients who have failed at least one line of a standard treatment.
Descrição

Standard therapy Quantity failed

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0231175
7. no serious mental disorder.
Descrição

Absence Mental disorders Serious

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0004936
UMLS CUI [1,3]
C0205404
8. patients must have adequate cardiac function(no cardiac disease, lvef≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(cr≤133umol/l).
Descrição

Cardiac function | Heart Disease Absent | Left ventricular ejection fraction | Pulmonary function | Oxygen saturation measurement on room air | Renal function | Creatinine measurement, serum

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0428772
UMLS CUI [4]
C0231921
UMLS CUI [5,1]
C0523807
UMLS CUI [5,2]
C2709070
UMLS CUI [6]
C0232804
UMLS CUI [7]
C0201976
9. no other serious diseases(autoimmune disease, immunodeficiency etc.).
Descrição

Absence Disease Serious | Autoimmune Disease Absent | Immunodeficiency Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0205404
UMLS CUI [2,1]
C0004364
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0021051
UMLS CUI [3,2]
C0332197
10. no other tumors.
Descrição

Cancer Other Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0332197
11. patients volunteer to participate in the research.
Descrição

Participates as a volunteer Research

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1821911
UMLS CUI [1,2]
C0035168
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. kps<50.
Descrição

Karnofsky Performance Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0206065
2. patients are allergic to cytokines.
Descrição

Hypersensitivity Cytokine

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0079189
3. central nervous system leukemia within 28 days.
Descrição

Central nervous system leukaemia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1332884
4. uncontrolled active infection.
Descrição

Communicable Disease Uncontrolled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
5. acute or chronic gvhd.
Descrição

Graft-vs-Host Disease | Chronic graft-versus-host disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018133
UMLS CUI [2]
C0867389
6. treated with t cell inhibitor.
Descrição

T cell Inhibitors

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0039194
UMLS CUI [1,2]
C0243077
7. pregnancy and nursing females.
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
8. hiv affected.
Descrição

HIV Infection

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019693
9. other situations we think improper for the research.
Descrição

Social situation Inappropriate Research

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0748872
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0035168
Voltar ao início da página

Similar models

Eligibility Leukemia NCT02349698

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02349698
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Adult B Acute Lymphoblastic Leukemia Recurrent | Adult B Acute Lymphoblastic Leukemia Refractory | Chronic Lymphocytic Leukemia | Lymphoma, Non-Hodgkin
Item
1. relapsed or refractory b cell derived acute lymphoblastic leukemia(all), chronic lymphoblastic leukemia(cll) and non-hodgkin lymphoma.
boolean
C0279593 (UMLS CUI [1,1])
C2945760 (UMLS CUI [1,2])
C0279593 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C0023434 (UMLS CUI [3])
C0024305 (UMLS CUI [4])
Karnofsky Performance Status
Item
2. kps>60.
boolean
C0206065 (UMLS CUI [1])
Life Expectancy
Item
3. life expectancy>3 months.
boolean
C0023671 (UMLS CUI [1])
Age
Item
4. gender unlimited, age from 18 years to 70 years.
boolean
C0001779 (UMLS CUI [1])
Disease Progression
Item
5. disease progresses but reserves reaction to recent treatments.
boolean
C0242656 (UMLS CUI [1])
Standard therapy Quantity failed
Item
6. patients who have failed at least one line of a standard treatment.
boolean
C2936643 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Absence Mental disorders Serious
Item
7. no serious mental disorder.
boolean
C0332197 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
Cardiac function | Heart Disease Absent | Left ventricular ejection fraction | Pulmonary function | Oxygen saturation measurement on room air | Renal function | Creatinine measurement, serum
Item
8. patients must have adequate cardiac function(no cardiac disease, lvef≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(cr≤133umol/l).
boolean
C0232164 (UMLS CUI [1])
C0018799 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0428772 (UMLS CUI [3])
C0231921 (UMLS CUI [4])
C0523807 (UMLS CUI [5,1])
C2709070 (UMLS CUI [5,2])
C0232804 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
Absence Disease Serious | Autoimmune Disease Absent | Immunodeficiency Absent
Item
9. no other serious diseases(autoimmune disease, immunodeficiency etc.).
boolean
C0332197 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0004364 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0021051 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Cancer Other Absent
Item
10. no other tumors.
boolean
C1707251 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Participates as a volunteer Research
Item
11. patients volunteer to participate in the research.
boolean
C1821911 (UMLS CUI [1,1])
C0035168 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Karnofsky Performance Status
Item
1. kps<50.
boolean
C0206065 (UMLS CUI [1])
Hypersensitivity Cytokine
Item
2. patients are allergic to cytokines.
boolean
C0020517 (UMLS CUI [1,1])
C0079189 (UMLS CUI [1,2])
Central nervous system leukaemia
Item
3. central nervous system leukemia within 28 days.
boolean
C1332884 (UMLS CUI [1])
Communicable Disease Uncontrolled
Item
4. uncontrolled active infection.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Graft-vs-Host Disease | Chronic graft-versus-host disease
Item
5. acute or chronic gvhd.
boolean
C0018133 (UMLS CUI [1])
C0867389 (UMLS CUI [2])
T cell Inhibitors
Item
6. treated with t cell inhibitor.
boolean
C0039194 (UMLS CUI [1,1])
C0243077 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
7. pregnancy and nursing females.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Infection
Item
8. hiv affected.
boolean
C0019693 (UMLS CUI [1])
Social situation Inappropriate Research
Item
9. other situations we think improper for the research.
boolean
C0748872 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0035168 (UMLS CUI [1,3])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial