ID

17353

Beskrivning

R-CHOP-14 Versus R-CHOP-21 and Darbepoetin Alpha in Patients Aged 60-80 Years With Diffuse Large B-cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00144755

Länk

https://clinicaltrials.gov/show/NCT00144755

Nyckelord

  1. 2016-09-07 2016-09-07 -
Uppladdad den

7 september 2016

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Diffuse Large Cell Lymphoma NCT00144755

Eligibility Diffuse Large Cell Lymphoma NCT00144755

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with histologically proven cd20+ diffuse large b cell lymphoma (who classification).
Beskrivning

Diffuse Large B-Cell Lymphoma Cell positive for CD20 antigen

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079744
UMLS CUI [1,2]
C0882818
aged 66 to 80 years old. patients not previously treated. ann arbor stage ii, iii, iv. ecog performance status 0 to 2. age-adjusted ipi equal to 1, 2, or 3. with a minimum life expectancy of 3 months. negative hiv, hbv and hcv serologies test < 4 weeks (except after vaccination for hbv).
Beskrivning

Age | Patient untreated | Ann Arbor lymphoma staging system | ECOG performance status | International Prognostic Index | Life Expectancy | HIV negative | hepatitis b serology Negative | hepatitis C serology test Negative | Hepatitis B vaccination

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0332155
UMLS CUI [3]
C0432516
UMLS CUI [4]
C1520224
UMLS CUI [5]
C1512894
UMLS CUI [6]
C0023671
UMLS CUI [7]
C0481430
UMLS CUI [8,1]
C0744837
UMLS CUI [8,2]
C1513916
UMLS CUI [9,1]
C0850489
UMLS CUI [9,2]
C1513916
UMLS CUI [10]
C0474232
having signed a written informed consent.
Beskrivning

Informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
any other histological type of lymphoma. 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

Lymphoma Histologic type | indolent lymphoma | Diffuse Large B-Cell Lymphoma | Cellular infiltration Bone Marrow | Cellular infiltration lymph nodes

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0449574
UMLS CUI [2]
C1334170
UMLS CUI [3]
C0079744
UMLS CUI [4,1]
C1692321
UMLS CUI [4,2]
C0005953
UMLS CUI [5,1]
C1692321
UMLS CUI [5,2]
C0024204
central nervous system or meningeal involvement by lymphoma. contra-indication to any drug contained in the chemotherapy regimens. any serious co-morbid active disease (according to the investigator's decision).
Beskrivning

Central Nervous System Involvement with Lymphoma | Meninges Involvement with Lymphoma | Medical contraindication Pharmaceutical Preparation Related Chemotherapy Regimen | Comorbidity Serious

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3714787
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C0024299
UMLS CUI [2,1]
C0025285
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0024299
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C0439849
UMLS CUI [3,4]
C0392920
UMLS CUI [4,1]
C0009488
UMLS CUI [4,2]
C0205404
poor renal function (creatinin level > 150 micromol/l), poor hepatic function (total bilirubin level > 30mmol/l, transaminases > 2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
Beskrivning

Renal function Poor | Creatinine measurement | Liver function Poor | Bilirubin, total measurement | Transaminases increased | Abnormality Related Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0542537
UMLS CUI [2]
C0201975
UMLS CUI [3,1]
C0232741
UMLS CUI [3,2]
C0542537
UMLS CUI [4]
C0201913
UMLS CUI [5]
C0438717
UMLS CUI [6,1]
C1704258
UMLS CUI [6,2]
C0439849
UMLS CUI [6,3]
C0024299
poor bone marrow reserve as defined by neutrophils < 1.5 g/l or platelets < 100 g/l, unless related to bone marrow infiltration.
Beskrivning

Few mature neutrophils in the bone marrow | Absolute neutrophil count | Platelet Count measurement | Few mature neutrophils in the bone marrow Related Bone marrow infiltration

Datatyp

boolean

Alias
UMLS CUI [1]
C2748959
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4,1]
C2748959
UMLS CUI [4,2]
C0439849
UMLS CUI [4,3]
C3854434
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

Malignant Neoplasms | Skin carcinoma | Carcinoma in situ of uterine cervix

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0699893
UMLS CUI [3]
C0851140
uncontrolled hypertension. known hypersensitivity to erythropoietin. myocardial infarction during last 3 month, or unstable coronary disease, or uncontrolled cardiac insufficiency.
Beskrivning

Uncontrolled hypertension | Hypersensitivity Erythropoietin | Myocardial Infarction | Coronary Artery Disease Unstable | Heart failure Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0014822
UMLS CUI [3]
C0027051
UMLS CUI [4,1]
C1956346
UMLS CUI [4,2]
C0443343
UMLS CUI [5,1]
C0018801
UMLS CUI [5,2]
C0205318
venous thrombosis or pulmonary embolism during last 3 months. treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
Beskrivning

Venous Thrombosis | Pulmonary Embolism | Investigational New Drug | Chemotherapy Regimen

Datatyp

boolean

Alias
UMLS CUI [1]
C0042487
UMLS CUI [2]
C0034065
UMLS CUI [3]
C0013230
UMLS CUI [4]
C0392920
pregnant or lactating women. adult patient under tutelage.
Beskrivning

Pregnancy | Breast Feeding | Adult associated with guardianship

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0001675
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C0870627

Similar models

Eligibility Diffuse Large Cell Lymphoma NCT00144755

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Diffuse Large B-Cell Lymphoma Cell positive for CD20 antigen
Item
patients with histologically proven cd20+ diffuse large b cell lymphoma (who classification).
boolean
C0079744 (UMLS CUI [1,1])
C0882818 (UMLS CUI [1,2])
Age | Patient untreated | Ann Arbor lymphoma staging system | ECOG performance status | International Prognostic Index | Life Expectancy | HIV negative | hepatitis b serology Negative | hepatitis C serology test Negative | Hepatitis B vaccination
Item
aged 66 to 80 years old. patients not previously treated. ann arbor stage ii, iii, iv. ecog performance status 0 to 2. age-adjusted ipi equal to 1, 2, or 3. with a minimum life expectancy of 3 months. negative hiv, hbv and hcv serologies test < 4 weeks (except after vaccination for hbv).
boolean
C0001779 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0432516 (UMLS CUI [3])
C1520224 (UMLS CUI [4])
C1512894 (UMLS CUI [5])
C0023671 (UMLS CUI [6])
C0481430 (UMLS CUI [7])
C0744837 (UMLS CUI [8,1])
C1513916 (UMLS CUI [8,2])
C0850489 (UMLS CUI [9,1])
C1513916 (UMLS CUI [9,2])
C0474232 (UMLS CUI [10])
Informed consent
Item
having signed a written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Lymphoma Histologic type | indolent lymphoma | Diffuse Large B-Cell Lymphoma | Cellular infiltration Bone Marrow | Cellular infiltration lymph nodes
Item
any other histological type of lymphoma. 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
C0024299 (UMLS CUI [1,1])
C0449574 (UMLS CUI [1,2])
C1334170 (UMLS CUI [2])
C0079744 (UMLS CUI [3])
C1692321 (UMLS CUI [4,1])
C0005953 (UMLS CUI [4,2])
C1692321 (UMLS CUI [5,1])
C0024204 (UMLS CUI [5,2])
Central Nervous System Involvement with Lymphoma | Meninges Involvement with Lymphoma | Medical contraindication Pharmaceutical Preparation Related Chemotherapy Regimen | Comorbidity Serious
Item
central nervous system or meningeal involvement by lymphoma. contra-indication to any drug contained in the chemotherapy regimens. any serious co-morbid active disease (according to the investigator's decision).
boolean
C3714787 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0024299 (UMLS CUI [1,3])
C0025285 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0024299 (UMLS CUI [2,3])
C1301624 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0392920 (UMLS CUI [3,4])
C0009488 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
Renal function Poor | Creatinine measurement | Liver function Poor | Bilirubin, total measurement | Transaminases increased | Abnormality Related Lymphoma
Item
poor renal function (creatinin level > 150 micromol/l), poor hepatic function (total bilirubin level > 30mmol/l, transaminases > 2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
boolean
C0232804 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C0201975 (UMLS CUI [2])
C0232741 (UMLS CUI [3,1])
C0542537 (UMLS CUI [3,2])
C0201913 (UMLS CUI [4])
C0438717 (UMLS CUI [5])
C1704258 (UMLS CUI [6,1])
C0439849 (UMLS CUI [6,2])
C0024299 (UMLS CUI [6,3])
Few mature neutrophils in the bone marrow | Absolute neutrophil count | Platelet Count measurement | Few mature neutrophils in the bone marrow Related Bone marrow infiltration
Item
poor bone marrow reserve as defined by neutrophils < 1.5 g/l or platelets < 100 g/l, unless related to bone marrow infiltration.
boolean
C2748959 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C2748959 (UMLS CUI [4,1])
C0439849 (UMLS CUI [4,2])
C3854434 (UMLS CUI [4,3])
Malignant Neoplasms | Skin carcinoma | Carcinoma in situ of uterine cervix
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])
C0699893 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
Uncontrolled hypertension | Hypersensitivity Erythropoietin | Myocardial Infarction | Coronary Artery Disease Unstable | Heart failure Uncontrolled
Item
uncontrolled hypertension. known hypersensitivity to erythropoietin. myocardial infarction during last 3 month, or unstable coronary disease, or uncontrolled cardiac insufficiency.
boolean
C1868885 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0014822 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C1956346 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0018801 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
Venous Thrombosis | Pulmonary Embolism | Investigational New Drug | Chemotherapy Regimen
Item
venous thrombosis or pulmonary embolism during last 3 months. treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
boolean
C0042487 (UMLS CUI [1])
C0034065 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
Pregnancy | Breast Feeding | Adult associated with guardianship
Item
pregnant or lactating women. adult patient under tutelage.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0001675 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0870627 (UMLS CUI [3,3])

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