ID

31068

Description

Retreatment Study of Galiximab + Rituximab in Follicular Non-Hodgkin's Lymphoma (NHL); ODM derived from: https://clinicaltrials.gov/show/NCT00384150

Link

https://clinicaltrials.gov/show/NCT00384150

Keywords

Versions (1)
  1. 7/17/18 7/17/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 17, 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 :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

No comments

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

Eligibility Non-Hodgkin Lymphoma NCT00384150

English

Eligibility Non-Hodgkin Lymphoma NCT00384150

1 forms  
Criteria
Description

Criteria

demonstrated a response (cr, cru, or pr) on study 114-nh-301 (galiximab in combination with rituximab compared with rituximab in combination with placebo) and then relapsed or progressed with a ttp >=6 months. relapsed disease is defined as documented disease progression using the international workshop response criteria (iwrc).
Description

Disease Response | In complete remission | Complete remission Uncertain | Partial response | galiximab/rituximab | Rituximab Placebo Combined | Recurrent disease | Disease Progression | Time to Progression

Data type

boolean

Alias
UMLS CUI [1]
C1704632
UMLS CUI [2]
C0677874
UMLS CUI [3,1]
C0677874
UMLS CUI [3,2]
C0087130
UMLS CUI [4]
C1521726
UMLS CUI [5]
C1327912
UMLS CUI [6,1]
C0393022
UMLS CUI [6,2]
C1696465
UMLS CUI [6,3]
C0205195
UMLS CUI [7]
C0277556
UMLS CUI [8]
C0242656
UMLS CUI [9]
C2985467
bidimensionally measurable disease with at least 1 lesion >=2.0 cm in a single dimension.
Description

Measurable Disease 2-Dimensional | Lesion Size Linear Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0456389
UMLS CUI [2,3]
C0205132
UMLS CUI [2,4]
C1265611
acceptable hematologic, hepatic, and renal function.
Description

Hematologic function | Liver function | Renal function

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
key exclusion criteria:
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
any lymphoma therapy between final visit on study 114-nh-301 and study day 1 of this retreatment study.
Description

Therapeutic procedure Lymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0024299
chronic or intermittent corticosteroids for inflammatory or autoimmune disorders within 3 weeks prior to study day 1.
Description

Adrenal Cortex Hormones chronic Inflammatory disorder | Adrenal Cortex Hormones chronic Autoimmune Diseases | Adrenal Cortex Hormones Intermittent Inflammatory disorder | Adrenal Cortex Hormones Intermittent Autoimmune Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C1290884
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C0205191
UMLS CUI [2,3]
C0004364
UMLS CUI [3,1]
C0001617
UMLS CUI [3,2]
C0205267
UMLS CUI [3,3]
C1290884
UMLS CUI [4,1]
C0001617
UMLS CUI [4,2]
C0205267
UMLS CUI [4,3]
C0004364
transfusion-dependent subjects.
Description

Study Subject Transfusion dependent

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1698624
presence of central nervous system (cns) lymphoma.
Description

Central nervous system lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0742472
histologic transformation.
Description

Transformation Histologic

Data type

boolean

Alias
UMLS CUI [1,1]
C0040682
UMLS CUI [1,2]
C0205462
presence of pleural or peritoneal effusion with positive cytology for lymphoma.
Description

Pleural effusion | Peritoneal effusion | Positive Cytology Lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0032227
UMLS CUI [2]
C0003964
UMLS CUI [3,1]
C3846509
UMLS CUI [3,2]
C0024299
another primary malignancy requiring active treatment.
Description

Primary tumor Treatment required for

Data type

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0332121
serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions that would compromise protocol objectives in the opinion of the investigator and/or the sponsor.
Description

Disease Serious Non-Malignant | Congestive heart failure | Hydronephrosis | Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled | Condition compromises Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1518371
UMLS CUI [2]
C0018802
UMLS CUI [3]
C0020295
UMLS CUI [4,1]
C0004623
UMLS CUI [4,2]
C0205318
UMLS CUI [5,1]
C0042769
UMLS CUI [5,2]
C0205318
UMLS CUI [6,1]
C0026946
UMLS CUI [6,2]
C0205318
UMLS CUI [7,1]
C0348080
UMLS CUI [7,2]
C2945640
UMLS CUI [7,3]
C2348563
new york heart association class iii or iv cardiac disease or myocardial infarction within 6 months prior to study day 1.
Description

Heart Disease New York Heart Association Classification | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0027051
Back to the top of the page

Similar models

Eligibility Non-Hodgkin Lymphoma NCT00384150

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Disease Response | In complete remission | Complete remission Uncertain | Partial response | galiximab/rituximab | Rituximab Placebo Combined | Recurrent disease | Disease Progression | Time to Progression
Item
demonstrated a response (cr, cru, or pr) on study 114-nh-301 (galiximab in combination with rituximab compared with rituximab in combination with placebo) and then relapsed or progressed with a ttp >=6 months. relapsed disease is defined as documented disease progression using the international workshop response criteria (iwrc).
boolean
C1704632 (UMLS CUI [1])
C0677874 (UMLS CUI [2])
C0677874 (UMLS CUI [3,1])
C0087130 (UMLS CUI [3,2])
C1521726 (UMLS CUI [4])
C1327912 (UMLS CUI [5])
C0393022 (UMLS CUI [6,1])
C1696465 (UMLS CUI [6,2])
C0205195 (UMLS CUI [6,3])
C0277556 (UMLS CUI [7])
C0242656 (UMLS CUI [8])
C2985467 (UMLS CUI [9])
Measurable Disease 2-Dimensional | Lesion Size Linear Quantity
Item
bidimensionally measurable disease with at least 1 lesion >=2.0 cm in a single dimension.
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0205132 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
Hematologic function | Liver function | Renal function
Item
acceptable hematologic, hepatic, and renal function.
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Therapeutic procedure Lymphoma
Item
any lymphoma therapy between final visit on study 114-nh-301 and study day 1 of this retreatment study.
boolean
C0087111 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
Adrenal Cortex Hormones chronic Inflammatory disorder | Adrenal Cortex Hormones chronic Autoimmune Diseases | Adrenal Cortex Hormones Intermittent Inflammatory disorder | Adrenal Cortex Hormones Intermittent Autoimmune Diseases
Item
chronic or intermittent corticosteroids for inflammatory or autoimmune disorders within 3 weeks prior to study day 1.
boolean
C0001617 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C1290884 (UMLS CUI [1,3])
C0001617 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0004364 (UMLS CUI [2,3])
C0001617 (UMLS CUI [3,1])
C0205267 (UMLS CUI [3,2])
C1290884 (UMLS CUI [3,3])
C0001617 (UMLS CUI [4,1])
C0205267 (UMLS CUI [4,2])
C0004364 (UMLS CUI [4,3])
Study Subject Transfusion dependent
Item
transfusion-dependent subjects.
boolean
C0681850 (UMLS CUI [1,1])
C1698624 (UMLS CUI [1,2])
Central nervous system lymphoma
Item
presence of central nervous system (cns) lymphoma.
boolean
C0742472 (UMLS CUI [1])
Transformation Histologic
Item
histologic transformation.
boolean
C0040682 (UMLS CUI [1,1])
C0205462 (UMLS CUI [1,2])
Pleural effusion | Peritoneal effusion | Positive Cytology Lymphoma
Item
presence of pleural or peritoneal effusion with positive cytology for lymphoma.
boolean
C0032227 (UMLS CUI [1])
C0003964 (UMLS CUI [2])
C3846509 (UMLS CUI [3,1])
C0024299 (UMLS CUI [3,2])
Primary tumor Treatment required for
Item
another primary malignancy requiring active treatment.
boolean
C0677930 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Disease Serious Non-Malignant | Congestive heart failure | Hydronephrosis | Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled | Condition compromises Study Protocol
Item
serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions that would compromise protocol objectives in the opinion of the investigator and/or the sponsor.
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1518371 (UMLS CUI [1,3])
C0018802 (UMLS CUI [2])
C0020295 (UMLS CUI [3])
C0004623 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0042769 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0026946 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
C0348080 (UMLS CUI [7,1])
C2945640 (UMLS CUI [7,2])
C2348563 (UMLS CUI [7,3])
Heart Disease New York Heart Association Classification | Myocardial Infarction
Item
new york heart association class iii or iv cardiac disease or myocardial infarction within 6 months prior to study day 1.
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0027051 (UMLS CUI [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