ID

21066

Beskrivning

An Efficacy and Tolerability Study of Bortezomib in Combination With Rituximab Standard Therapy in Participants With Relapsed or Refractory Follicular Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01902862

Länk

https://clinicaltrials.gov/show/NCT01902862

Nyckelord

Versioner (1)
  1. 2017-04-07 2017-04-07 -
Uppladdad den

7 april 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Lymphoma, Follicular NCT01902862

Engelsk

Eligibility Lymphoma, Follicular NCT01902862

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants with histologically confirmed relapsed or refractory follicular stage iii or iv, grade 1 and 2, cluster of differentiation 20 plus (cd20+) lymphoma (who-world health organization) that requires therapy
Beskrivning

Lymphoma, Follicular; histological diagnosis; Recurrent disease; Refractory Disease | Lymphoma stage | Cell positive for CD20 antigen

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C0679557
UMLS CUI [1,3]
C0277556
UMLS CUI [1,4]
C1514815
UMLS CUI [2]
C1272836
UMLS CUI [3]
C0882818
participants in whom treatment with rituximab is planned after greater than or equal to 2 cytostatic (inhibition of cell growth) previous therapies
Beskrivning

rituximab planned, prior chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0393022
UMLS CUI [1,2]
C1301732
UMLS CUI [2]
C1514457
women must be either postmenopausal or sterilized; negative pregnancy test at screening
Beskrivning

postmenopausal state, sterilized, pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3]
C0032961
participants with total bilirubin below 1.5-fold upper limit of normal (uln) and creatinine below 2-fold uln
Beskrivning

total bilirubin, creatinine

Datatyp

boolean

Alias
UMLS CUI [1]
C0201913
UMLS CUI [2]
C0201976
participants with karnofsky status greater than or equal to 60 percent
Beskrivning

karnofsky

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants with previous treatment with bortezomib within 6 months before enrollment or previous treatment with a combination of rituximab and bortezomib
Beskrivning

Prior Therapy; bortezomib | Prior Therapy; bortezomib/rituximab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1176309
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C1541445
participants with previous known allergic reaction to bortezomib, boron or mannitol
Beskrivning

previous known allergic reaction to bortezomib, boron or mannitol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1176309
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0024730
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0006030
participants with life-expectancy of less than 3 months
Beskrivning

life-expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
participants with malignant neoplasm (cancerous - new growth that is not normal; tumor) (except basalioma) within previous 5 years
Beskrivning

history of cancer, basalioma

Datatyp

boolean

Alias
UMLS CUI [1]
C2735088
UMLS CUI [2]
C0007117
participants with peripheral (not central) neuropathy (a disturbance in the function of the brain or spinal cord that may affect the nerves and muscles of the body) common terminology criteria for adverse events (ctcae) grade greater than or equal to 2
Beskrivning

peripheral neuropathy, common terminology criteria for adverse events (ctcae)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C3888020
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Similar models

Eligibility Lymphoma, Follicular NCT01902862

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Lymphoma, Follicular; histological diagnosis; Recurrent disease; Refractory Disease | Lymphoma stage | Cell positive for CD20 antigen
Item
participants with histologically confirmed relapsed or refractory follicular stage iii or iv, grade 1 and 2, cluster of differentiation 20 plus (cd20+) lymphoma (who-world health organization) that requires therapy
boolean
C0024301 (UMLS CUI [1,1])
C0679557 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,3])
C1514815 (UMLS CUI [1,4])
C1272836 (UMLS CUI [2])
C0882818 (UMLS CUI [3])
rituximab planned, prior chemotherapy
Item
participants in whom treatment with rituximab is planned after greater than or equal to 2 cytostatic (inhibition of cell growth) previous therapies
boolean
C0393022 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1514457 (UMLS CUI [2])
postmenopausal state, sterilized, pregnancy
Item
women must be either postmenopausal or sterilized; negative pregnancy test at screening
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0032961 (UMLS CUI [3])
total bilirubin, creatinine
Item
participants with total bilirubin below 1.5-fold upper limit of normal (uln) and creatinine below 2-fold uln
boolean
C0201913 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
karnofsky
Item
participants with karnofsky status greater than or equal to 60 percent
boolean
C0206065 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Therapy; bortezomib | Prior Therapy; bortezomib/rituximab
Item
participants with previous treatment with bortezomib within 6 months before enrollment or previous treatment with a combination of rituximab and bortezomib
boolean
C1514463 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C1541445 (UMLS CUI [2,2])
previous known allergic reaction to bortezomib, boron or mannitol
Item
participants with previous known allergic reaction to bortezomib, boron or mannitol
boolean
C0020517 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0024730 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0006030 (UMLS CUI [3,2])
life-expectancy
Item
participants with life-expectancy of less than 3 months
boolean
C0023671 (UMLS CUI [1])
history of cancer, basalioma
Item
participants with malignant neoplasm (cancerous - new growth that is not normal; tumor) (except basalioma) within previous 5 years
boolean
C2735088 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
peripheral neuropathy, common terminology criteria for adverse events (ctcae)
Item
participants with peripheral (not central) neuropathy (a disturbance in the function of the brain or spinal cord that may affect the nerves and muscles of the body) common terminology criteria for adverse events (ctcae) grade greater than or equal to 2
boolean
C0031117 (UMLS CUI [1,1])
C3888020 (UMLS CUI [1,2])
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