ID

39053

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT01040871

Trefwoorden

Versies (1)
  1. 24-11-19 24-11-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

24 november 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Diffuse Large B-Cell Lymphoma NCT01040871

Engels

Eligibility Diffuse Large B-Cell Lymphoma NCT01040871

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Age

Datatype

boolean

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

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

Datatype

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.
Beschrijving

Measurable Disease Site Quantity

Datatype

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
Beschrijving

ECOG performance status

Datatype

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.
Beschrijving

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

Datatype

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
Beschrijving

Gender Barrier Contraception Double

Datatype

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with velcade.
Beschrijving

Velcade

Datatype

boolean

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

Therapeutic radiology procedure Extended Lymphoma | Chemotherapy Extended Lymphoma

Datatype

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
Beschrijving

Doxorubicin Dosage

Datatype

boolean

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

Major surgery

Datatype

boolean

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

Peripheral Neuropathy CTCAE grades | Neuralgia CTCAE grades

Datatype

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
Beschrijving

Central nervous system lymphoma

Datatype

boolean

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

Malignant Neoplasms | Cancer treatment | Exception Non-Hodgkin Lymphoma

Datatype

boolean

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

Pregnancy | Breast Feeding

Datatype

boolean

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

Sepsis

Datatype

boolean

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

HIV Infection Suspected | AIDS Suspected

Datatype

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
Beschrijving

Cardiovascular Disease Uncontrolled | Cardiovascular Disease Severe

Datatype

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
Beschrijving

Hypersensitivity Investigational New Drugs | Intolerance to Investigational New Drugs

Datatype

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
Beschrijving

Medical condition Interferes with Clinical Trial

Datatype

boolean

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

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
Terug naar het begin van de pagina

Similar models

Eligibility Diffuse Large B-Cell Lymphoma NCT01040871

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial