ID

21754

Description

CHOP-Rituximab Augmented With GM-CSF in Patients With Previously Untreated Diffuse Large B Cell Non-Hodgkin's Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00455897

Link

https://clinicaltrials.gov/show/NCT00455897

Keywords

Versions (1)
  1. 4/28/17 4/28/17 -
Uploaded on

April 28, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Lymphoma, Non-Hodgkin NCT00455897

English

Eligibility Lymphoma, Non-Hodgkin NCT00455897

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed diagnosis of diffuse large b cell non-hodgkin's lymphoma with characteristic immunophenotypic profile
Description

Diffuse Large B-Cell Lymphoma Positive Immunophenotypic Test Result

Data type

boolean

Alias
UMLS CUI [1,1]
C0079744
UMLS CUI [1,2]
C1514242
patient has not received any prior anti-cancer therapy for lymphoma
Description

Lymphoma Cancer treatment Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0920425
UMLS CUI [1,3]
C0332197
tumor tissue confirmed to express the cd20 antigen by flow cytometry or immunohistochemistry
Description

Tumor tissue CD20 Antigen Gene Expression Flow Cytometry | Tumor tissue CD20 Antigen Gene Expression Immunohistochemistry

Data type

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0054946
UMLS CUI [1,3]
C0017262
UMLS CUI [1,4]
C0016263
UMLS CUI [2,1]
C0475358
UMLS CUI [2,2]
C0054946
UMLS CUI [2,3]
C0017262
UMLS CUI [2,4]
C0021044
measurable disease as defined by a tumor mass of 1cm or greater in one dimension
Description

Measurable Disease | Tumor Mass Diameter

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C3273930
UMLS CUI [2,2]
C1301886
stage ii (abdominal-not xrt appropriate), iii, or iv disease
Description

Disorder of abdomen Ann Arbor lymphoma staging system | Therapeutic radiology procedure Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C1290864
UMLS CUI [1,2]
C0432516
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C1548788
age > 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status of 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
laboratory parameters as outlined in protocol
Description

Laboratory Results Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C2348563
patient agrees to use birth control
Description

Contraceptive methods Agree

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C3641827
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known central nervous system involvement by lymphoma
Description

Central Nervous System Involvement Lymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C4050309
UMLS CUI [1,2]
C0024299
serious uncontrolled concurrent illness such as active coronary artery disease, severe copd, chf, active alcohol abuse, active concurrent malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix
Description

Comorbidity Uncontrolled | Coronary Artery Disease | Severe chronic obstructive pulmonary disease | Congestive heart failure | Alcohol abuse | Malignant Neoplasms | Skin carcinoma | Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C1956346
UMLS CUI [3]
C0730607
UMLS CUI [4]
C0018802
UMLS CUI [5]
C0085762
UMLS CUI [6]
C0006826
UMLS CUI [7]
C0699893
UMLS CUI [8]
C0851140
any evidence of prior natural exposure to hepatitis b
Description

Hepatitis B Exposure to Evidence

Data type

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0332157
UMLS CUI [1,3]
C3887511
active rheumatologic disease which may be exacerbated by gm-csf
Description

Rheumatic disease | Disease Exacerbation Due to Granulocyte-Macrophage Colony-Stimulating Factor

Data type

boolean

Alias
UMLS CUI [1]
C0035435
UMLS CUI [2,1]
C0235874
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0079460
cardiac ejection fraction less than 45%
Description

Cardiac ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0232174
known hiv disease
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
patient is pregnant or nursing
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patient is receiving other investigational drugs
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Lymphoma, Non-Hodgkin NCT00455897

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diffuse Large B-Cell Lymphoma Positive Immunophenotypic Test Result
Item
histologically confirmed diagnosis of diffuse large b cell non-hodgkin's lymphoma with characteristic immunophenotypic profile
boolean
C0079744 (UMLS CUI [1,1])
C1514242 (UMLS CUI [1,2])
Lymphoma Cancer treatment Absent
Item
patient has not received any prior anti-cancer therapy for lymphoma
boolean
C0024299 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Tumor tissue CD20 Antigen Gene Expression Flow Cytometry | Tumor tissue CD20 Antigen Gene Expression Immunohistochemistry
Item
tumor tissue confirmed to express the cd20 antigen by flow cytometry or immunohistochemistry
boolean
C0475358 (UMLS CUI [1,1])
C0054946 (UMLS CUI [1,2])
C0017262 (UMLS CUI [1,3])
C0016263 (UMLS CUI [1,4])
C0475358 (UMLS CUI [2,1])
C0054946 (UMLS CUI [2,2])
C0017262 (UMLS CUI [2,3])
C0021044 (UMLS CUI [2,4])
Measurable Disease | Tumor Mass Diameter
Item
measurable disease as defined by a tumor mass of 1cm or greater in one dimension
boolean
C1513041 (UMLS CUI [1])
C3273930 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
Disorder of abdomen Ann Arbor lymphoma staging system | Therapeutic radiology procedure Inappropriate
Item
stage ii (abdominal-not xrt appropriate), iii, or iv disease
boolean
C1290864 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
Age
Item
age > 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0-2
boolean
C1520224 (UMLS CUI [1])
Laboratory Results Study Protocol
Item
laboratory parameters as outlined in protocol
boolean
C1254595 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Contraceptive methods Agree
Item
patient agrees to use birth control
boolean
C0700589 (UMLS CUI [1,1])
C3641827 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Central Nervous System Involvement Lymphoma
Item
known central nervous system involvement by lymphoma
boolean
C4050309 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
Comorbidity Uncontrolled | Coronary Artery Disease | Severe chronic obstructive pulmonary disease | Congestive heart failure | Alcohol abuse | Malignant Neoplasms | Skin carcinoma | Carcinoma in situ of uterine cervix
Item
serious uncontrolled concurrent illness such as active coronary artery disease, severe copd, chf, active alcohol abuse, active concurrent malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1956346 (UMLS CUI [2])
C0730607 (UMLS CUI [3])
C0018802 (UMLS CUI [4])
C0085762 (UMLS CUI [5])
C0006826 (UMLS CUI [6])
C0699893 (UMLS CUI [7])
C0851140 (UMLS CUI [8])
Hepatitis B Exposure to Evidence
Item
any evidence of prior natural exposure to hepatitis b
boolean
C0019163 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C3887511 (UMLS CUI [1,3])
Rheumatic disease | Disease Exacerbation Due to Granulocyte-Macrophage Colony-Stimulating Factor
Item
active rheumatologic disease which may be exacerbated by gm-csf
boolean
C0035435 (UMLS CUI [1])
C0235874 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0079460 (UMLS CUI [2,3])
Cardiac ejection fraction
Item
cardiac ejection fraction less than 45%
boolean
C0232174 (UMLS CUI [1])
HIV Infection
Item
known hiv disease
boolean
C0019693 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
patient is pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Investigational New Drugs
Item
patient is receiving other investigational drugs
boolean
C0013230 (UMLS CUI [1])
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