ID

15848

Beskrivning

R-ACVBP Versus R-CHOP in Patients Aged 60-65 With Diffuse Large B-Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00135499

Länk

https://clinicaltrials.gov/show/NCT00135499

Nyckelord

  1. 2016-06-15 2016-06-15 -
Uppladdad den

15 juni 2016

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Lymphoma, Large-Cell, Diffuse NCT00135499

Eligibility Lymphoma, Large-Cell, Diffuse NCT00135499

Inclusion Criteria
Beskrivning

Inclusion Criteria

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

diffuse large b-cell lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0079744
aged from 60 to 65 years.
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
not previously treated.
Beskrivning

previous treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C0087111
ann arbor stage ii, iii, iv.
Beskrivning

ann arbor stage

Datatyp

boolean

Alias
UMLS CUI [1]
C0432516
ecog performance status 0 to 2.
Beskrivning

ecog performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
minimum life expectancy of 3 months.
Beskrivning

life expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
negative hiv, hepatitis b virus (hbv) and hepatitis c virus (hcv) serologies test  4 weeks (except after vaccination).
Beskrivning

serologies test

Datatyp

boolean

Alias
UMLS CUI [1]
C0019698
UMLS CUI [2]
C0853319
UMLS CUI [3]
C0201485
having previously signed a written informed consent.
Beskrivning

written informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
t-cell lymphoma.
Beskrivning

t-cell lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0079772
any history of treated or non-treated indolent lymphoma. however, patients not previously diagnosed and having a diffuse large b-cell lymphoma with some small cell infiltration in bone marrow or lymph node may be included.
Beskrivning

indolent lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C1334170
central nervous system or meningeal involvement by lymphoma.
Beskrivning

central nervous system involvement

Datatyp

boolean

Alias
UMLS CUI [1]
C0449389
UMLS CUI [2]
C2213017
contra-indication to any drug contained in the chemotherapy regimens.
Beskrivning

contraindication chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0392920
any serious active disease (according to the investigator’s decision).
Beskrivning

serious active disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
poor renal function (creatinine level>150micromol/l), poor hepatic function (total bilirubin level>30mmol/l, transaminases>2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
Beskrivning

abnormalities

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0002594
poor bone marrow reserve as defined by neutrophils<1.5g/l or platelets<100g/l, unless related to bone marrow infiltration.
Beskrivning

poor bone marrow reserve

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0005821
any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
Beskrivning

history of cancer

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
Beskrivning

investigational drug

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
adult patient under tutelage.
Beskrivning

tutelage

Datatyp

boolean

Similar models

Eligibility Lymphoma, Large-Cell, Diffuse NCT00135499

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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 from 60 to 65 years.
boolean
C0001779 (UMLS CUI [1])
previous treatment
Item
not previously treated.
boolean
C0087111 (UMLS CUI [1])
ann arbor stage
Item
ann arbor stage ii, iii, iv.
boolean
C0432516 (UMLS CUI [1])
ecog performance status
Item
ecog performance status 0 to 2.
boolean
C1520224 (UMLS CUI [1])
life expectancy
Item
minimum life expectancy of 3 months.
boolean
C0023671 (UMLS CUI [1])
serologies test
Item
negative hiv, hepatitis b virus (hbv) and hepatitis c virus (hcv) serologies test  4 weeks (except after vaccination).
boolean
C0019698 (UMLS CUI [1])
C0853319 (UMLS CUI [2])
C0201485 (UMLS CUI [3])
written informed consent
Item
having previously signed a written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
t-cell lymphoma
Item
t-cell lymphoma.
boolean
C0079772 (UMLS CUI [1])
indolent lymphoma
Item
any history of treated or non-treated indolent lymphoma. however, patients not previously diagnosed and having a diffuse large b-cell lymphoma with some small cell infiltration in bone marrow or lymph node may be included.
boolean
C1334170 (UMLS CUI [1])
central nervous system involvement
Item
central nervous system or meningeal involvement by lymphoma.
boolean
C0449389 (UMLS CUI [1])
C2213017 (UMLS CUI [2])
contraindication chemotherapy
Item
contra-indication to any drug contained in the chemotherapy regimens.
boolean
C1301624 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
serious active disease
Item
any serious active disease (according to the investigator’s decision).
boolean
C0009488 (UMLS CUI [1])
abnormalities
Item
poor renal function (creatinine level>150micromol/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])
C1278039 (UMLS CUI [2])
C0002594 (UMLS CUI [3])
poor bone marrow reserve
Item
poor bone marrow reserve as defined by neutrophils<1.5g/l or platelets<100g/l, unless related to bone marrow infiltration.
boolean
C0948762 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
history of cancer
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])
investigational drug
Item
treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
boolean
C2348568 (UMLS CUI [1])
tutelage
Item
adult patient under tutelage.
boolean

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