ID

14469

Descrição

ACVBP Followed by ASCT in Patients With BCL-2 Positive Diffuse Large B-Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00169130

Link

https://clinicaltrials.gov/show/NCT00169130

Palavras-chave

Versões (1)
  1. 17/04/2016 17/04/2016 -
Transferido a

17 de abril de 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Lymphoma, Large-Cell, Diffuse NCT00169130

Inglês

Eligibility Lymphoma, Large-Cell, Diffuse NCT00169130

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient with diffuse large b-cell lymphoma according to the who classification (anti cd20 labeling)
Descrição

Diffuse large b-cell lymphoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079744
aged 18 to 60 years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
non previously treated
Descrição

Previous treatment

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0087111
with one and only one of the following adverse characteristics: ecog performance status 2 or more, or ann arbor stage iii or iv, or elevated ldh level
Descrição

ECOG performance status, ann arbor stage and ldh level

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0432516
UMLS CUI [3]
C0202113
negative hiv, hbv and hcv serologies (except vaccination)
Descrição

HIV, HBV, HVC Serologoy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019698
UMLS CUI [2]
C0853319
UMLS CUI [3]
C0201485
with a minimum life expectancy of 3 months
Descrição

Life expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
having previously signed a written informed consent
Descrição

Informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
any history of treated or non-treated indolent lymphoma.
Descrição

Indolent lymphoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1334170
t-cell lymphoma.
Descrição

T-cell lymphoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079772
central nervous system or meningeal involvement by lymphoma.
Descrição

CNS or meningeal lymphoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0280803
UMLS CUI [2]
C2213017
any contra-indication to any drug contained in the chemotherapy regimens.
Descrição

Contraindication to chemotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0392920
poor renal function (creatinin level>150µmol/l), poor hepatic function (total bilirubin level>30mmol/l, transaminases>2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
Descrição

Renal and hepatic functio

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0201913
UMLS CUI [3]
C0919834
serious active disease (according to the investigator’s decision).
Descrição

Comorbidity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009488
poor bone marrow reserve as defined by neutrophils <1.5g/l or platelets<100g/l, unless related to bone marrow infiltration.
Descrição

Bone marrow function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0032181
any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
Descrição

Further malignancies

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0007114
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C2216722
treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
Descrição

Experimental drug

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0304229
childbearing woman.
Descrição

Pregnancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
patients previously treated with an organ transplantation.
Descrição

Organ transplantation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0029216
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Similar models

Eligibility Lymphoma, Large-Cell, Diffuse NCT00169130

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Diffuse large b-cell lymphoma
Item
patient with diffuse large b-cell lymphoma according to the who classification (anti cd20 labeling)
boolean
C0079744 (UMLS CUI [1])
Age
Item
aged 18 to 60 years
boolean
C0001779 (UMLS CUI [1])
Previous treatment
Item
non previously treated
boolean
C0087111 (UMLS CUI [1])
ECOG performance status, ann arbor stage and ldh level
Item
with one and only one of the following adverse characteristics: ecog performance status 2 or more, or ann arbor stage iii or iv, or elevated ldh level
boolean
C1520224 (UMLS CUI [1])
C0432516 (UMLS CUI [2])
C0202113 (UMLS CUI [3])
HIV, HBV, HVC Serologoy
Item
negative hiv, hbv and hcv serologies (except vaccination)
boolean
C0019698 (UMLS CUI [1])
C0853319 (UMLS CUI [2])
C0201485 (UMLS CUI [3])
Life expectancy
Item
with a minimum life expectancy of 3 months
boolean
C0023671 (UMLS CUI [1])
Informed consent
Item
having previously signed a written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Indolent lymphoma
Item
any history of treated or non-treated indolent lymphoma.
boolean
C1334170 (UMLS CUI [1])
T-cell lymphoma
Item
t-cell lymphoma.
boolean
C0079772 (UMLS CUI [1])
CNS or meningeal lymphoma
Item
central nervous system or meningeal involvement by lymphoma.
boolean
C0280803 (UMLS CUI [1])
C2213017 (UMLS CUI [2])
Contraindication to chemotherapy
Item
any contra-indication to any drug contained in the chemotherapy regimens.
boolean
C1301624 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
Renal and hepatic functio
Item
poor renal function (creatinin level>150µmol/l), poor hepatic function (total bilirubin level>30mmol/l, transaminases>2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
boolean
C0201976 (UMLS CUI [1])
C0201913 (UMLS CUI [2])
C0919834 (UMLS CUI [3])
Comorbidity
Item
serious active disease (according to the investigator’s decision).
boolean
C0009488 (UMLS CUI [1])
Bone marrow function
Item
poor bone marrow reserve as defined by neutrophils <1.5g/l or platelets<100g/l, unless related to bone marrow infiltration.
boolean
C0200633 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Further malignancies
Item
any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
boolean
C0006826 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0007114 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C2216722 (UMLS CUI [2,3])
Experimental drug
Item
treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
boolean
C0304229 (UMLS CUI [1])
Pregnancy
Item
childbearing woman.
boolean
C0032961 (UMLS CUI [1])
Organ transplantation
Item
patients previously treated with an organ transplantation.
boolean
C0029216 (UMLS CUI [1])
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