ID

21545

Descripción

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

Palabras clave

Versiones (1)
  1. 26/4/17 26/4/17 -
Subido en

26 de abril de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Lymphoma, Follicular NCT00193492

Inglés

Eligibility Lymphoma, Follicular NCT00193492

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

criteria Fulfill

Tipo de datos

boolean

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

Follicular Lymphoma Ann Arbor lymphoma staging system Biopsy sample

Tipo de datos

boolean

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

Age

Tipo de datos

boolean

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

Disease Progression Evidence of

Tipo de datos

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.
Descripción

Chemotherapy Regimen Quantity

Tipo de datos

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.
Descripción

rituximab Treatment completed | Disease Progression Duration

Tipo de datos

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
Descripción

Measurable Disease | Evaluable Disease

Tipo de datos

boolean

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

Activities of Daily Living Perform Able

Tipo de datos

boolean

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

Bone Marrow function | Renal function | Liver function

Tipo de datos

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.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

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

Study Subject Participation Status

Tipo de datos

boolean

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

Chemotherapy Regimen Quantity

Tipo de datos

boolean

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

bevacizumab | Bevacizumab Pharmaceutical Preparations Similar

Tipo de datos

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
Descripción

rituximab | Non-Hodgkin Lymphoma Progressive

Tipo de datos

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
Descripción

Therapeutic procedure Quantity Investigational New Drugs

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

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

Tipo de datos

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.
Descripción

Clinical Trial Eligibility Criteria Additional

Tipo de datos

boolean

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

Eligibility Lymphoma, Follicular NCT00193492

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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