0 Evaluaciones

ID

17353

Descripción

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

Link

https://clinicaltrials.gov/show/NCT00144755

Palabras clave

  1. 7/9/16 7/9/16 -
Subido en

7 de septiembre de 2016

DOI

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Licencia

Creative Commons BY 4.0

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    Eligibility Diffuse Large Cell Lymphoma NCT00144755

    Eligibility Diffuse Large Cell Lymphoma NCT00144755

    Inclusion Criteria
    Descripción

    Inclusion Criteria

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

    Diffuse Large B-Cell Lymphoma Cell positive for CD20 antigen

    Tipo de datos

    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).
    Descripción

    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

    Tipo de datos

    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.
    Descripción

    Informed consent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Descripción

    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.
    Descripción

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

    Tipo de datos

    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).
    Descripción

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

    Tipo de datos

    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.
    Descripción

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

    Tipo de datos

    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.
    Descripción

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

    Tipo de datos

    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.
    Descripción

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

    Tipo de datos

    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.
    Descripción

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

    Tipo de datos

    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.
    Descripción

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

    Tipo de datos

    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.
    Descripción

    Pregnancy | Breast Feeding | Adult associated with guardianship

    Tipo de datos

    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
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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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