ID

31068

Description

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

Lien

https://clinicaltrials.gov/show/NCT00384150

Mots-clés

Versions (1)
  1. 17/07/2018 17/07/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

17 juillet 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Non-Hodgkin Lymphoma NCT00384150

Anglais

Eligibility Non-Hodgkin Lymphoma NCT00384150

1 Formulaires  
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

Type de données

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

Type de données

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

Type de données

boolean

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

Exclusion Criteria Main

Type de données

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

Type de données

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

Type de données

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

Type de données

boolean

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

Central nervous system lymphoma

Type de données

boolean

Alias
UMLS CUI [1]
C0742472
histologic transformation.
Description

Transformation Histologic

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0027051
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Similar models

Eligibility Non-Hodgkin Lymphoma NCT00384150

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
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