ID

31474

Beschreibung

Study of MDX-1203 in Subjects With Advanced/Recurrent Clear Cell Renal Cell Carcinoma (ccRCC) or Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (B-NHL); ODM derived from: https://clinicaltrials.gov/show/NCT00944905

Link

https://clinicaltrials.gov/show/NCT00944905

Stichworte

Versionen (2)
  1. 26.08.18 26.08.18 -
  2. 27.08.18 27.08.18 - Sarah Riepenhausen
Rechteinhaber

Bristol-Myers Squibb

Hochgeladen am

27. August 2018

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Renal Cell Carcinoma and B-Cell Non-Hodgkin's Lymphoma NCT00944905

Englisch

Eligibility Renal Cell Carcinoma and B-Cell Non-Hodgkin's Lymphoma NCT00944905

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
eastern cooperative oncology group (ecog) performance status of 0 to 2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
criteria specific for each tumor type: for clear cell renal cell carcinoma (ccrcc): advanced or recurrent disease. must have failed at least 1 prior systemic therapy
Beschreibung

Advanced or recurrent clear cell renal cell carcinoma, prior therapy failed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279702
UMLS CUI [1,2]
C0679246
UMLS CUI [1,3]
C1514463
UMLS CUI [1,4]
C0231175
UMLS CUI [2,1]
C0279702
UMLS CUI [2,2]
C0277556
UMLS CUI [2,3]
C1514463
UMLS CUI [2,4]
C0231175
criteria specific for each tumor type: for b-cell non-hodgkin's lymphoma (b-nhl): must have failed at least 1 prior systemic therapy
Beschreibung

b-nhl with prior systemic therapy failed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0231175
measurable disease criteria by tumor type: for ccrcc: at least 1 unidimensional measurable lesion
Beschreibung

Clear cell renal cell carcinoma: measurable lesion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279702
UMLS CUI [1,2]
C1513041
measurable disease criteria by tumor type: for b-nhl: at least 1 bidimensionally measurable lesion
Beschreibung

B-nhl: measurable bidimensional lesion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C1513041
UMLS CUI [1,3]
C1705052
prior therapies for advanced/recurrent ccrcc or relapsed/refractory b-nhl or have become intolerant to a systemic therapy
Beschreibung

Prior therapy for advanced/recurrent clear cell renal cell carcinoma or relapsed/refractory b-nhl

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0279702
UMLS CUI [1,3]
C0679246
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0279702
UMLS CUI [2,3]
C0277556
UMLS CUI [3,1]
C1514463
UMLS CUI [3,2]
C0855089
UMLS CUI [4,1]
C1514463
UMLS CUI [4,2]
C0855090
UMLS CUI [5,1]
C1744706
UMLS CUI [5,2]
C1515119
provide archived or fresh tumor tissue for cd70 status. subjects must be cd70+
Beschreibung

CD70 antigen positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514241
UMLS CUI [1,2]
C0215991
provision of fresh tissue (pre-treatment and on-treatment) for exploratory analysis is mandatory for at least 5 and a maximum of 10 b-nhl subjects
Beschreibung

Provision of fresh tumor tissue

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1292533
UMLS CUI [1,2]
C2827486
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior therapy with an anti-cd70 antibody
Beschreibung

Prior therapy with an anti-cd70 antibody

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0281176
UMLS CUI [1,3]
C0215991
history of severe hypersensitivity reactions to other monoclonal antibodies
Beschreibung

Hypersensitivity to monoclonal antibodies

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0003250
active or untreated central nervous system lymphoma
Beschreibung

CNS lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0280803
active infection (viral, bacterial, or fungal)
Beschreibung

Infection

Datentyp

boolean

Alias
UMLS CUI [1]
C3714514
evidence of bleeding diathesis or coagulopathy
Beschreibung

Bleeding diathesis or coagulopathy

Datentyp

boolean

Alias
UMLS CUI [1]
C0005779
active autoimmune disease requiring immunosuppressive therapy
Beschreibung

Concomitant autoimmune disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021079
UMLS CUI [1,2]
C0004364
known current drug or alcohol abuse
Beschreibung

Substance abuse

Datentyp

boolean

Alias
UMLS CUI [1]
C0013146
UMLS CUI [2]
C0085762
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Renal Cell Carcinoma and B-Cell Non-Hodgkin's Lymphoma NCT00944905

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0 to 2
boolean
C1520224 (UMLS CUI [1])
Advanced or recurrent clear cell renal cell carcinoma, prior therapy failed
Item
criteria specific for each tumor type: for clear cell renal cell carcinoma (ccrcc): advanced or recurrent disease. must have failed at least 1 prior systemic therapy
boolean
C0279702 (UMLS CUI [1,1])
C0679246 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
C0279702 (UMLS CUI [2,1])
C0277556 (UMLS CUI [2,2])
C1514463 (UMLS CUI [2,3])
C0231175 (UMLS CUI [2,4])
b-nhl with prior systemic therapy failed
Item
criteria specific for each tumor type: for b-cell non-hodgkin's lymphoma (b-nhl): must have failed at least 1 prior systemic therapy
boolean
C0024305 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Clear cell renal cell carcinoma: measurable lesion
Item
measurable disease criteria by tumor type: for ccrcc: at least 1 unidimensional measurable lesion
boolean
C0279702 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
B-nhl: measurable bidimensional lesion
Item
measurable disease criteria by tumor type: for b-nhl: at least 1 bidimensionally measurable lesion
boolean
C0024305 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
C1705052 (UMLS CUI [1,3])
Prior therapy for advanced/recurrent clear cell renal cell carcinoma or relapsed/refractory b-nhl
Item
prior therapies for advanced/recurrent ccrcc or relapsed/refractory b-nhl or have become intolerant to a systemic therapy
boolean
C1514463 (UMLS CUI [1,1])
C0279702 (UMLS CUI [1,2])
C0679246 (UMLS CUI [1,3])
C1514463 (UMLS CUI [2,1])
C0279702 (UMLS CUI [2,2])
C0277556 (UMLS CUI [2,3])
C1514463 (UMLS CUI [3,1])
C0855089 (UMLS CUI [3,2])
C1514463 (UMLS CUI [4,1])
C0855090 (UMLS CUI [4,2])
C1744706 (UMLS CUI [5,1])
C1515119 (UMLS CUI [5,2])
CD70 antigen positive
Item
provide archived or fresh tumor tissue for cd70 status. subjects must be cd70+
boolean
C1514241 (UMLS CUI [1,1])
C0215991 (UMLS CUI [1,2])
Provision of fresh tumor tissue
Item
provision of fresh tissue (pre-treatment and on-treatment) for exploratory analysis is mandatory for at least 5 and a maximum of 10 b-nhl subjects
boolean
C1292533 (UMLS CUI [1,1])
C2827486 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Prior therapy with an anti-cd70 antibody
Item
prior therapy with an anti-cd70 antibody
boolean
C1514463 (UMLS CUI [1,1])
C0281176 (UMLS CUI [1,2])
C0215991 (UMLS CUI [1,3])
Hypersensitivity to monoclonal antibodies
Item
history of severe hypersensitivity reactions to other monoclonal antibodies
boolean
C0020517 (UMLS CUI [1,1])
C0003250 (UMLS CUI [1,2])
CNS lymphoma
Item
active or untreated central nervous system lymphoma
boolean
C0280803 (UMLS CUI [1])
Infection
Item
active infection (viral, bacterial, or fungal)
boolean
C3714514 (UMLS CUI [1])
Bleeding diathesis or coagulopathy
Item
evidence of bleeding diathesis or coagulopathy
boolean
C0005779 (UMLS CUI [1])
Concomitant autoimmune disease
Item
active autoimmune disease requiring immunosuppressive therapy
boolean
C0021079 (UMLS CUI [1,1])
C0004364 (UMLS CUI [1,2])
Substance abuse
Item
known current drug or alcohol abuse
boolean
C0013146 (UMLS CUI [1])
C0085762 (UMLS CUI [2])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video