ID

31474

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00944905

Nyckelord

Versioner (2)
  1. 2018-08-26 2018-08-26 -
  2. 2018-08-27 2018-08-27 - Sarah Riepenhausen
Rättsinnehavare

Bristol-Myers Squibb

Uppladdad den

27 augusti 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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Eligibility Renal Cell Carcinoma and B-Cell Non-Hodgkin's Lymphoma NCT00944905

Engelsk

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

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

ECOG performance status

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

b-nhl with prior systemic therapy failed

Datatyp

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
Beskrivning

Clear cell renal cell carcinoma: measurable lesion

Datatyp

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
Beskrivning

B-nhl: measurable bidimensional lesion

Datatyp

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
Beskrivning

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

Datatyp

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+
Beskrivning

CD70 antigen positive

Datatyp

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
Beskrivning

Provision of fresh tumor tissue

Datatyp

boolean

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

Exclusion Criteria

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

Prior therapy with an anti-cd70 antibody

Datatyp

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
Beskrivning

Hypersensitivity to monoclonal antibodies

Datatyp

boolean

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

CNS lymphoma

Datatyp

boolean

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

Infection

Datatyp

boolean

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

Bleeding diathesis or coagulopathy

Datatyp

boolean

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

Concomitant autoimmune disease

Datatyp

boolean

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

Substance abuse

Datatyp

boolean

Alias
UMLS CUI [1]
C0013146
UMLS CUI [2]
C0085762
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Similar models

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

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
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