ID

31078

Beschrijving

A Study of YM155 Plus Rituximab in Subjects With Non-Hodgkin's Lymphoma Who Have Received Prior Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT01007292

Link

https://clinicaltrials.gov/show/NCT01007292

Trefwoorden

Versies (1)
  1. 18-07-18 18-07-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

18 juli 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Non-Hodgkin's Lymphoma NCT01007292

Engels

Eligibility Non-Hodgkin's Lymphoma NCT01007292

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
any stage, histologically confirmed cd20-positive primary or transformed diffuse large b cell lymphoma (dlbcl)or grade 3 follicular lymphoma (fl)
Beschrijving

Diffuse Large B-Cell Lymphoma Primary CD20 positive Ann Arbor lymphoma staging system | Diffuse Large B-Cell Lymphoma Transformation CD20 positive Ann Arbor lymphoma staging system | Follicular Lymphoma Ann Arbor lymphoma staging system

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079744
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C3888518
UMLS CUI [1,4]
C0432516
UMLS CUI [2,1]
C0079744
UMLS CUI [2,2]
C0040682
UMLS CUI [2,3]
C3888518
UMLS CUI [2,4]
C0432516
UMLS CUI [3,1]
C0024301
UMLS CUI [3,2]
C0432516
ineligible for or have previously received an autologous stem cell transplant (asct)
Beschrijving

Ineligibility Autologous hematopoietic stem cell transplant | Autologous hematopoietic stem cell transplant Previous

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512714
UMLS CUI [1,2]
C2193200
UMLS CUI [2,1]
C2193200
UMLS CUI [2,2]
C0205156
relapsed following receipt of the last dose of systemic chemotherapy or asct
Beschrijving

Recurrent disease Post Systemic Chemotherapy | Recurrent disease Post Autologous hematopoietic stem cell transplant

Datatype

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C1883256
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C2193200
at least one prior chemotherapy regimen. prior chemotherapy regimen must have contained anthracycline (unless contraindicated)
Beschrijving

Prior Chemotherapy Quantity | Anthracyclines | Exception Anthracyclines Contraindicated

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0282564
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0282564
UMLS CUI [3,3]
C1444657
if the subject is female, she must be non-pregnant and non-lactating at the baseline visit. all sexually active males and females of childbearing potential must agree to use an adequate method of contraception throughout the study period
Beschrijving

Gender | Pregnancy Absent | Breast Feeding Absent | Females & males of reproductive potential Sexually active Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0006147
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C4034483
UMLS CUI [4,2]
C0241028
UMLS CUI [4,3]
C0700589
eastern cooperative oncology group (ecog) performance status </= 1
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of any standard/experimental anti-lymphoma drug therapy within 21 days of the baseline visit
Beschrijving

Pharmacotherapy Standard Against Lymphoma | Pharmacotherapy Investigational Against Lymphoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C1442989
UMLS CUI [1,3]
C0521124
UMLS CUI [1,4]
C0024299
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C1517586
UMLS CUI [2,3]
C0521124
UMLS CUI [2,4]
C0024299
use of systemic steroids within 5 days of the baseline visit (except for the purposes of pre-medication prior to study regimen treatment)
Beschrijving

Systemic steroids | Exception Premedication

Datatype

boolean

Alias
UMLS CUI [1]
C2825233
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0033045
prior allogeneic stem cell transplant (sct)
Beschrijving

Allogeneic Stem Cell Transplantation Previous

Datatype

boolean

Alias
UMLS CUI [1,1]
C2242529
UMLS CUI [1,2]
C0205156
the subject has been previously treated with ym155
Beschrijving

YM-155 Use of Previous

Datatype

boolean

Alias
UMLS CUI [1,1]
C2002939
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C0205156
the subject has known human immunodeficiency virus (hiv), hepatitis b surface antigen, or hepatitis c antibody
Beschrijving

HIV Seropositivity | Hepatitis B surface antigen positive | Hepatitis C antibody positive

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0149709
UMLS CUI [3]
C0281863
the subject has received other investigational therapy or procedures within 21 days prior to the first study drug administration
Beschrijving

Therapies, Investigational | Procedures Investigational

Datatype

boolean

Alias
UMLS CUI [1]
C0949266
UMLS CUI [2,1]
C0184661
UMLS CUI [2,2]
C1517586
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Similar models

Eligibility Non-Hodgkin's Lymphoma NCT01007292

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Diffuse Large B-Cell Lymphoma Primary CD20 positive Ann Arbor lymphoma staging system | Diffuse Large B-Cell Lymphoma Transformation CD20 positive Ann Arbor lymphoma staging system | Follicular Lymphoma Ann Arbor lymphoma staging system
Item
any stage, histologically confirmed cd20-positive primary or transformed diffuse large b cell lymphoma (dlbcl)or grade 3 follicular lymphoma (fl)
boolean
C0079744 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C3888518 (UMLS CUI [1,3])
C0432516 (UMLS CUI [1,4])
C0079744 (UMLS CUI [2,1])
C0040682 (UMLS CUI [2,2])
C3888518 (UMLS CUI [2,3])
C0432516 (UMLS CUI [2,4])
C0024301 (UMLS CUI [3,1])
C0432516 (UMLS CUI [3,2])
Ineligibility Autologous hematopoietic stem cell transplant | Autologous hematopoietic stem cell transplant Previous
Item
ineligible for or have previously received an autologous stem cell transplant (asct)
boolean
C1512714 (UMLS CUI [1,1])
C2193200 (UMLS CUI [1,2])
C2193200 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Recurrent disease Post Systemic Chemotherapy | Recurrent disease Post Autologous hematopoietic stem cell transplant
Item
relapsed following receipt of the last dose of systemic chemotherapy or asct
boolean
C0277556 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C1883256 (UMLS CUI [1,3])
C0277556 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C2193200 (UMLS CUI [2,3])
Prior Chemotherapy Quantity | Anthracyclines | Exception Anthracyclines Contraindicated
Item
at least one prior chemotherapy regimen. prior chemotherapy regimen must have contained anthracycline (unless contraindicated)
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0282564 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0282564 (UMLS CUI [3,2])
C1444657 (UMLS CUI [3,3])
Gender | Pregnancy Absent | Breast Feeding Absent | Females & males of reproductive potential Sexually active Contraceptive methods
Item
if the subject is female, she must be non-pregnant and non-lactating at the baseline visit. all sexually active males and females of childbearing potential must agree to use an adequate method of contraception throughout the study period
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C4034483 (UMLS CUI [4,1])
C0241028 (UMLS CUI [4,2])
C0700589 (UMLS CUI [4,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status </= 1
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pharmacotherapy Standard Against Lymphoma | Pharmacotherapy Investigational Against Lymphoma
Item
use of any standard/experimental anti-lymphoma drug therapy within 21 days of the baseline visit
boolean
C0013216 (UMLS CUI [1,1])
C1442989 (UMLS CUI [1,2])
C0521124 (UMLS CUI [1,3])
C0024299 (UMLS CUI [1,4])
C0013216 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C0521124 (UMLS CUI [2,3])
C0024299 (UMLS CUI [2,4])
Systemic steroids | Exception Premedication
Item
use of systemic steroids within 5 days of the baseline visit (except for the purposes of pre-medication prior to study regimen treatment)
boolean
C2825233 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0033045 (UMLS CUI [2,2])
Allogeneic Stem Cell Transplantation Previous
Item
prior allogeneic stem cell transplant (sct)
boolean
C2242529 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
YM-155 Use of Previous
Item
the subject has been previously treated with ym155
boolean
C2002939 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
HIV Seropositivity | Hepatitis B surface antigen positive | Hepatitis C antibody positive
Item
the subject has known human immunodeficiency virus (hiv), hepatitis b surface antigen, or hepatitis c antibody
boolean
C0019699 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C0281863 (UMLS CUI [3])
Therapies, Investigational | Procedures Investigational
Item
the subject has received other investigational therapy or procedures within 21 days prior to the first study drug administration
boolean
C0949266 (UMLS CUI [1])
C0184661 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
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