ID

17354

Beschreibung

ACVBP Versus ACVBP Plus Rituximab in Low Risk Localized Diffuse Large B-cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00140660

Link

https://clinicaltrials.gov/show/NCT00140660

Stichworte

  1. 07.09.16 07.09.16 -
  2. 07.09.16 07.09.16 -
  3. 07.09.16 07.09.16 -
Hochgeladen am

7. September 2016

DOI

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Lizenz

Creative Commons BY 4.0

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    Eligibility Diffuse Large Cell Lymphoma NCT00140660

    Eligibility Diffuse Large Cell Lymphoma NCT00140660

    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    patient with histologically proven cd20+ diffuse large b-cell lymphoma (who classification).
    Beschreibung

    Diffuse Large B-Cell Lymphoma Cell positive for CD20 antigen

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0079744
    UMLS CUI [1,2]
    C0882818
    age from 18 to 65 years.
    Beschreibung

    Age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    patient not previously treated.
    Beschreibung

    Patient untreated

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C0332155
    ann arbor stage i or ii.
    Beschreibung

    Ann Arbor lymphoma staging system

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0432516
    ecog performance status < 2.
    Beschreibung

    ECOG performance status

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    normal ldh.
    Beschreibung

    Blood lactate dehydrogenase normal

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0853788
    negative hiv, hbv and hcv serologies 4 weeks (except after vaccination).
    Beschreibung

    HIV negative | hepatitis b serology Negative | hepatitis C serology test Negative | Vaccination

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0481430
    UMLS CUI [2,1]
    C0744837
    UMLS CUI [2,2]
    C1513916
    UMLS CUI [3,1]
    C0850489
    UMLS CUI [3,2]
    C1513916
    UMLS CUI [4]
    C0042196
    having previously signed a written informed consent.
    Beschreibung

    Informed consent

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    any other histological type of lymphoma. vany 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 lymph node may be included.
    Beschreibung

    Lymphoma Histologic type | indolent lymphoma | Diffuse Large B-Cell Lymphoma | Cellular infiltration Lymph nodes

    Datentyp

    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]
    C0024204
    central nervous system or meningeal involvement by lymphoma.
    Beschreibung

    Central Nervous System Involvement with Lymphoma | Meninges Involvement with Lymphoma

    Datentyp

    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
    contra-indication to any drug contained in the chemotherapy regimens.
    Beschreibung

    Medical contraindication Pharmaceutical Preparation Related Chemotherapy Regimen

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1301624
    UMLS CUI [1,2]
    C0013227
    UMLS CUI [1,3]
    C0439849
    UMLS CUI [1,4]
    C0392920
    poor renal function (creatinin level >150 mmol/l), poor hepatic function (total bilirubin level >30 mmol/l, transaminases >2.5 maximum normal level).
    Beschreibung

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

    Datentyp

    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
    poor bone marrow reserve as defined by neutrophils < 1.5 g/l or platelets < 100 g/l.
    Beschreibung

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

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2748959
    UMLS CUI [2]
    C0948762
    UMLS CUI [3]
    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.
    Beschreibung

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

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2]
    C0699893
    UMLS CUI [3]
    C0851140
    any serious active disease (according to the investigator's decision).
    Beschreibung

    Disease Serious

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0205404
    treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
    Beschreibung

    Investigational New Drugs | Chemotherapy

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0013230
    UMLS CUI [2]
    C0392920
    pregnant or lactating women
    Beschreibung

    Pregnancy | Breast Feeding

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    adult patient under tutelage.
    Beschreibung

    Adult Associated with guardianship

    Datentyp

    boolean

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

    Ähnliche Modelle

    Eligibility Diffuse Large Cell Lymphoma NCT00140660

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Diffuse Large B-Cell Lymphoma Cell positive for CD20 antigen
    Item
    patient with histologically proven cd20+ diffuse large b-cell lymphoma (who classification).
    boolean
    C0079744 (UMLS CUI [1,1])
    C0882818 (UMLS CUI [1,2])
    Age
    Item
    age from 18 to 65 years.
    boolean
    C0001779 (UMLS CUI [1])
    Patient untreated
    Item
    patient not previously treated.
    boolean
    C0030705 (UMLS CUI [1,1])
    C0332155 (UMLS CUI [1,2])
    Ann Arbor lymphoma staging system
    Item
    ann arbor stage i or ii.
    boolean
    C0432516 (UMLS CUI [1])
    ECOG performance status
    Item
    ecog performance status < 2.
    boolean
    C1520224 (UMLS CUI [1])
    Blood lactate dehydrogenase normal
    Item
    normal ldh.
    boolean
    C0853788 (UMLS CUI [1])
    HIV negative | hepatitis b serology Negative | hepatitis C serology test Negative | Vaccination
    Item
    negative hiv, hbv and hcv serologies 4 weeks (except after vaccination).
    boolean
    C0481430 (UMLS CUI [1])
    C0744837 (UMLS CUI [2,1])
    C1513916 (UMLS CUI [2,2])
    C0850489 (UMLS CUI [3,1])
    C1513916 (UMLS CUI [3,2])
    C0042196 (UMLS CUI [4])
    Informed consent
    Item
    having previously 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 Lymph nodes
    Item
    any other histological type of lymphoma. vany 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 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])
    C0024204 (UMLS CUI [4,2])
    Central Nervous System Involvement with Lymphoma | Meninges Involvement with Lymphoma
    Item
    central nervous system or meningeal involvement by lymphoma.
    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])
    Medical contraindication Pharmaceutical Preparation Related Chemotherapy Regimen
    Item
    contra-indication to any drug contained in the chemotherapy regimens.
    boolean
    C1301624 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C0439849 (UMLS CUI [1,3])
    C0392920 (UMLS CUI [1,4])
    Renal function Poor | Creatinine measurement | Liver function Poor | Bilirubin, total measurement | Transaminases increased
    Item
    poor renal function (creatinin level >150 mmol/l), poor hepatic function (total bilirubin level >30 mmol/l, transaminases >2.5 maximum normal level).
    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])
    Few mature neutrophils in the bone marrow | Absolute neutrophil count | Platelet Count measurement
    Item
    poor bone marrow reserve as defined by neutrophils < 1.5 g/l or platelets < 100 g/l.
    boolean
    C2748959 (UMLS CUI [1])
    C0948762 (UMLS CUI [2])
    C0032181 (UMLS CUI [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])
    Disease Serious
    Item
    any serious active disease (according to the investigator's decision).
    boolean
    C0012634 (UMLS CUI [1,1])
    C0205404 (UMLS CUI [1,2])
    Investigational New Drugs | Chemotherapy
    Item
    treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
    boolean
    C0013230 (UMLS CUI [1])
    C0392920 (UMLS CUI [2])
    Pregnancy | Breast Feeding
    Item
    pregnant or lactating women
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Adult Associated with guardianship
    Item
    adult patient under tutelage.
    boolean
    C0001675 (UMLS CUI [1,1])
    C0332281 (UMLS CUI [1,2])
    C0870627 (UMLS CUI [1,3])

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