ID

30365

Description

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

Keywords

Versions (1)
  1. 5/30/18 5/30/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 30, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Lymphoma NCT00549185

English

Eligibility Lymphoma NCT00549185

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00549185
Inclusion Criteria
Description

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
Description

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

Data type

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
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

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

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

Data type

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
Description

Chemotherapy | Therapeutic radiology procedure | Investigational New Drugs

Data type

boolean

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

Radioimmunotherapy

Data type

boolean

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

Intolerance to Protein Product Infusion | Other Coding

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

Pregnancy | Breast Feeding

Data type

boolean

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

Females & males of reproductive potential Contraceptive methods Absent

Data type

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.
Description

Eligibility Criteria Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1524062
Back to the top of the page

Similar models

Eligibility Lymphoma NCT00549185

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00549185
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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