ID

30365

Descrição

Multi-dose-escalation Safety and Pharmacokinetic Study of SAR3419 as Single Agent in Relapsed/Refractory B-cell Non Hodgkin's Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00549185

Link

https://clinicaltrials.gov/show/NCT00549185

Palavras-chave

Versões (1)
  1. 30/05/2018 30/05/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

30 de maio de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Lymphoma NCT00549185

Inglês

Eligibility Lymphoma NCT00549185

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00549185
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed cd19-positive non-hodgkin's b-cell lymphoma, relapsed or refractory after standard treatments, with no curative option with conventional therapy
Descrição

B-Cell Lymphomas CD19 positive | Recurrent disease Post Standard of Care | Refractory Post Standard of Care | Absence Conventional Treatment Curative

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0079731
UMLS CUI [1,2]
C0882808
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C2936643
UMLS CUI [3,1]
C0205269
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C2936643
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C2945704
UMLS CUI [4,3]
C1276305
ecog performance status 0 to 2
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Descrição

Exclusion Criteria

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

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

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006413
UMLS CUI [2]
C0079748
UMLS CUI [3]
C0023434
UMLS CUI [4]
C0855095
chemotherapy or radiation therapy or other investigational agents within 4 weeks prior to entering the study
Descrição

Chemotherapy | Therapeutic radiology procedure | Investigational New Drugs

Tipo de dados

boolean

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

Radioimmunotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0085101
known intolerance to infused protein products or maytansinoids
Descrição

Intolerance to Protein Product Infusion | Other Coding

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0033684
UMLS CUI [1,3]
C1254351
UMLS CUI [1,4]
C0574032
UMLS CUI [2]
C3846158
poor kidney, liver and bone marrow functions
Descrição

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

Tipo de dados

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 with compliance with the study
Descrição

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

Tipo de dados

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

Pregnancy | Breast Feeding

Tipo de dados

boolean

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

Females & males of reproductive potential Contraceptive methods Absent

Tipo de dados

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.
Descrição

Eligibility Criteria Additional

Tipo de dados

boolean

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

Eligibility Lymphoma NCT00549185

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00549185
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
B-Cell Lymphomas CD19 positive | Recurrent disease Post Standard of Care | Refractory Post Standard of Care | Absence Conventional Treatment Curative
Item
histologically confirmed cd19-positive non-hodgkin's b-cell lymphoma, relapsed or refractory after standard treatments, with no curative option with conventional therapy
boolean
C0079731 (UMLS CUI [1,1])
C0882808 (UMLS CUI [1,2])
C0277556 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C2936643 (UMLS CUI [2,3])
C0205269 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C2936643 (UMLS CUI [3,3])
C0332197 (UMLS CUI [4,1])
C2945704 (UMLS CUI [4,2])
C1276305 (UMLS CUI [4,3])
ECOG performance status
Item
ecog performance status 0 to 2
boolean
C1520224 (UMLS CUI [1])
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])
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])
Intolerance to Protein Product Infusion | Other Coding
Item
known intolerance to infused protein products or maytansinoids
boolean
C1744706 (UMLS CUI [1,1])
C0033684 (UMLS CUI [1,2])
C1254351 (UMLS CUI [1,3])
C0574032 (UMLS CUI [1,4])
C3846158 (UMLS CUI [2])
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 | Disease Serious Interferes with Protocol Compliance | Comorbidity Interferes with Safety | 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 with 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])
C0012634 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
C0009488 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0036043 (UMLS CUI [3,3])
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
patient with reproductive potential without effective birth control methods
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
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
C1516637 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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