ID

21545

Description

A Study of Rituximab and Bevacizumab in Patients With Follicular Non-Hodgkin's Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00193492

Link

https://clinicaltrials.gov/show/NCT00193492

Keywords

Versions (1)
  1. 4/26/17 4/26/17 -
Uploaded on

April 26, 2017

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, Follicular NCT00193492

English

Eligibility Lymphoma, Follicular NCT00193492

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
to be included in the study, you must meet the following criteria:
Description

criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
follicular nhl, grades 1 or 2 confirmed by a biopsy sample
Description

Follicular Lymphoma Ann Arbor lymphoma staging system Biopsy sample

Data type

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C0432516
UMLS CUI [1,3]
C0677862
18 years of age or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
evidence of disease progression at time of study entry
Description

Disease Progression Evidence of

Data type

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0332120
must have had at least one previous chemotherapy regimen and not more than two previous chemotherapy regimens.
Description

Chemotherapy Regimen Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
patients who have received previous rituximab are eligible as long as progression occurred more than six months following completion of previous rituximab therapy.
Description

rituximab Treatment completed | Disease Progression Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0393022
UMLS CUI [1,2]
C0580352
UMLS CUI [2,1]
C0242656
UMLS CUI [2,2]
C0449238
measurable or evaluable disease
Description

Measurable Disease | Evaluable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
able to perform activities of daily living without considerable assistance
Description

Activities of Daily Living Perform Able

Data type

boolean

Alias
UMLS CUI [1,1]
C0001288
UMLS CUI [1,2]
C0884358
UMLS CUI [1,3]
C0085732
adequate bone marrow, kidney, and liver function
Description

Bone Marrow function | Renal function | Liver function

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
signed informed consent obtained prior to initiation of any study-specific procedures or treatment.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
you cannot participate in the study if any of the following apply to you:
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
treatment with more than two previous chemotherapy regimens
Description

Chemotherapy Regimen Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
prior treatment with bevacizumab or other similar agents
Description

bevacizumab | Bevacizumab Pharmaceutical Preparations Similar

Data type

boolean

Alias
UMLS CUI [1]
C0796392
UMLS CUI [2,1]
C0796392
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C2348205
progressive nhl less than 6 months after receiving previous rituximab
Description

rituximab | Non-Hodgkin Lymphoma Progressive

Data type

boolean

Alias
UMLS CUI [1]
C0393022
UMLS CUI [2,1]
C0024305
UMLS CUI [2,2]
C0205329
more than 1 prior treatment with investigational agents within 4 weeks prior to entering this study
Description

Therapeutic procedure Quantity Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0013230
spread of nhl to brain or nervous system
Description

Non-Hodgkin Lymphoma Metastatic malignant neoplasm to brain | Non-Hodgkin Lymphoma CNS metastases

Data type

boolean

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C0220650
UMLS CUI [2,1]
C0024305
UMLS CUI [2,2]
C0686377
history of any other uncontrolled or significant disease or medical condition that may put them at high risk for treatment complications with these agents
Description

Disease Uncontrolled High risk Complication for medication therapy | Medical condition High risk Complication for medication therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0332167
UMLS CUI [1,4]
C3266693
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0332167
UMLS CUI [2,3]
C3266693
please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have. you can then decide if you wish to participate.
Description

Clinical Trial 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, Follicular NCT00193492

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
criteria Fulfill
Item
to be included in the study, you must meet the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Follicular Lymphoma Ann Arbor lymphoma staging system Biopsy sample
Item
follicular nhl, grades 1 or 2 confirmed by a biopsy sample
boolean
C0024301 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
C0677862 (UMLS CUI [1,3])
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Disease Progression Evidence of
Item
evidence of disease progression at time of study entry
boolean
C0242656 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Chemotherapy Regimen Quantity
Item
must have had at least one previous chemotherapy regimen and not more than two previous chemotherapy regimens.
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
rituximab Treatment completed | Disease Progression Duration
Item
patients who have received previous rituximab are eligible as long as progression occurred more than six months following completion of previous rituximab therapy.
boolean
C0393022 (UMLS CUI [1,1])
C0580352 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Measurable Disease | Evaluable Disease
Item
measurable or evaluable disease
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
Activities of Daily Living Perform Able
Item
able to perform activities of daily living without considerable assistance
boolean
C0001288 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
Bone Marrow function | Renal function | Liver function
Item
adequate bone marrow, kidney, and liver function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Informed Consent
Item
signed informed consent obtained prior to initiation of any study-specific procedures or treatment.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status
Item
you cannot participate in the study if any of the following apply to you:
boolean
C2348568 (UMLS CUI [1])
Chemotherapy Regimen Quantity
Item
treatment with more than two previous chemotherapy regimens
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
bevacizumab | Bevacizumab Pharmaceutical Preparations Similar
Item
prior treatment with bevacizumab or other similar agents
boolean
C0796392 (UMLS CUI [1])
C0796392 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C2348205 (UMLS CUI [2,3])
rituximab | Non-Hodgkin Lymphoma Progressive
Item
progressive nhl less than 6 months after receiving previous rituximab
boolean
C0393022 (UMLS CUI [1])
C0024305 (UMLS CUI [2,1])
C0205329 (UMLS CUI [2,2])
Therapeutic procedure Quantity Investigational New Drugs
Item
more than 1 prior treatment with investigational agents within 4 weeks prior to entering this study
boolean
C0087111 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
Non-Hodgkin Lymphoma Metastatic malignant neoplasm to brain | Non-Hodgkin Lymphoma CNS metastases
Item
spread of nhl to brain or nervous system
boolean
C0024305 (UMLS CUI [1,1])
C0220650 (UMLS CUI [1,2])
C0024305 (UMLS CUI [2,1])
C0686377 (UMLS CUI [2,2])
Disease Uncontrolled High risk Complication for medication therapy | Medical condition High risk Complication for medication therapy
Item
history of any other uncontrolled or significant disease or medical condition that may put them at high risk for treatment complications with these agents
boolean
C0012634 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0332167 (UMLS CUI [1,3])
C3266693 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0332167 (UMLS CUI [2,2])
C3266693 (UMLS CUI [2,3])
Clinical Trial Eligibility Criteria Additional
Item
please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have. you can then decide if you wish to participate.
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