ID

39053

Beskrivning

Study of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01040871

Länk

https://clinicaltrials.gov/show/NCT01040871

Nyckelord

Versioner (1)
  1. 2019-11-24 2019-11-24 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

24 november 2019

DOI

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Creative Commons BY 4.0
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Eligibility Diffuse Large B-Cell Lymphoma NCT01040871

Engelsk

Eligibility Diffuse Large B-Cell Lymphoma NCT01040871

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female patients 18 years or older.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
newly diagnosed non-gcb subtype of dlbcl (stage ii, iii or iv).
Beskrivning

Diffuse Large B-Cell Lymphoma TNM clinical staging | Exception Germinal Center B-Cell Type

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079744
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1333295
at least 1 measurable site of disease.
Beskrivning

Measurable Disease Site Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C1265611
eastern cooperative oncology group (ecog) performance status 0-2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
female subjects must be postmenopausal (for at least 6 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry and throughout the study; and have a negative pregnancy test at screening.
Beskrivning

Postmenopausal state | Female Sterilization | Gender Sexual Abstinence | Gender Sexually active Contraceptive methods | Gender Pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0036899
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0241028
UMLS CUI [4,3]
C0700589
UMLS CUI [5,1]
C0079399
UMLS CUI [5,2]
C0427780
male subjects must agree to use a double barrier method of birth control
Beskrivning

Gender Barrier Contraception Double

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0004764
UMLS CUI [1,3]
C0205173
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with velcade.
Beskrivning

Velcade

Datatyp

boolean

Alias
UMLS CUI [1]
C1174739
prior extended radiotherapy or chemotherapy for lymphoma
Beskrivning

Therapeutic radiology procedure Extended Lymphoma | Chemotherapy Extended Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0231448
UMLS CUI [1,3]
C0024299
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0231448
UMLS CUI [2,3]
C0024299
more than 150 mg/m2 of prior doxorubicin
Beskrivning

Doxorubicin Dosage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013089
UMLS CUI [1,2]
C0178602
major surgery within 3 weeks of study.
Beskrivning

Major surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
peripheral neuropathy or neuralgia of grade 2 or worse.
Beskrivning

Peripheral Neuropathy CTCAE grades | Neuralgia CTCAE grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0027796
UMLS CUI [2,2]
C1516728
active cns lymphoma
Beskrivning

Central nervous system lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0742472
diagnosed or treated for a malignancy other than nhl, with some exceptions
Beskrivning

Malignant Neoplasms | Cancer treatment | Exception Non-Hodgkin Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0920425
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0024305
pregnant or breast feeding
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
active systemic infection
Beskrivning

Sepsis

Datatyp

boolean

Alias
UMLS CUI [1]
C0243026
documented of suspected human immunodeficiency virus (hiv)/aids
Beskrivning

HIV Infection Suspected | AIDS Suspected

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019693
UMLS CUI [1,2]
C0750491
UMLS CUI [2,1]
C0001175
UMLS CUI [2,2]
C0750491
uncontrolled or severe cardiovascular disease
Beskrivning

Cardiovascular Disease Uncontrolled | Cardiovascular Disease Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0205082
known allergies, hypersensitivity or intolerance to study drugs
Beskrivning

Hypersensitivity Investigational New Drugs | Intolerance to Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0013230
serious medical condition that could interfere with study
Beskrivning

Medical condition Interferes with Clinical Trial

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0008976
concurrent treatment with another investigational agent
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Diffuse Large B-Cell Lymphoma NCT01040871

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female patients 18 years or older.
boolean
C0001779 (UMLS CUI [1])
Diffuse Large B-Cell Lymphoma TNM clinical staging | Exception Germinal Center B-Cell Type
Item
newly diagnosed non-gcb subtype of dlbcl (stage ii, iii or iv).
boolean
C0079744 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1333295 (UMLS CUI [2,2])
Measurable Disease Site Quantity
Item
at least 1 measurable site of disease.
boolean
C1513041 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Postmenopausal state | Female Sterilization | Gender Sexual Abstinence | Gender Sexually active Contraceptive methods | Gender Pregnancy test negative
Item
female subjects must be postmenopausal (for at least 6 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry and throughout the study; and have a negative pregnancy test at screening.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0036899 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0241028 (UMLS CUI [4,2])
C0700589 (UMLS CUI [4,3])
C0079399 (UMLS CUI [5,1])
C0427780 (UMLS CUI [5,2])
Gender Barrier Contraception Double
Item
male subjects must agree to use a double barrier method of birth control
boolean
C0079399 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
C0205173 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Velcade
Item
prior treatment with velcade.
boolean
C1174739 (UMLS CUI [1])
Therapeutic radiology procedure Extended Lymphoma | Chemotherapy Extended Lymphoma
Item
prior extended radiotherapy or chemotherapy for lymphoma
boolean
C1522449 (UMLS CUI [1,1])
C0231448 (UMLS CUI [1,2])
C0024299 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C0231448 (UMLS CUI [2,2])
C0024299 (UMLS CUI [2,3])
Doxorubicin Dosage
Item
more than 150 mg/m2 of prior doxorubicin
boolean
C0013089 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Major surgery
Item
major surgery within 3 weeks of study.
boolean
C0679637 (UMLS CUI [1])
Peripheral Neuropathy CTCAE grades | Neuralgia CTCAE grades
Item
peripheral neuropathy or neuralgia of grade 2 or worse.
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0027796 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Central nervous system lymphoma
Item
active cns lymphoma
boolean
C0742472 (UMLS CUI [1])
Malignant Neoplasms | Cancer treatment | Exception Non-Hodgkin Lymphoma
Item
diagnosed or treated for a malignancy other than nhl, with some exceptions
boolean
C0006826 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0024305 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Sepsis
Item
active systemic infection
boolean
C0243026 (UMLS CUI [1])
HIV Infection Suspected | AIDS Suspected
Item
documented of suspected human immunodeficiency virus (hiv)/aids
boolean
C0019693 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C0001175 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Cardiovascular Disease Uncontrolled | Cardiovascular Disease Severe
Item
uncontrolled or severe cardiovascular disease
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Hypersensitivity Investigational New Drugs | Intolerance to Investigational New Drugs
Item
known allergies, hypersensitivity or intolerance to study drugs
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
Medical condition Interferes with Clinical Trial
Item
serious medical condition that could interfere with study
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Investigational New Drugs
Item
concurrent treatment with another investigational agent
boolean
C0013230 (UMLS CUI [1])
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