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ID

13207

Beschreibung

Combination Therapy With Fludarabine, Mitoxantrone and Rituximab in Mantle Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00183989

Link

https://clinicaltrials.gov/show/NCT00183989

Stichworte

Versionen (1)
  1. 24.01.16 24.01.16 -
Hochgeladen am

24. Januar 2016

DOI

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Creative Commons BY 4.0
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    Eligibility Mantle Cell Lymphoma NCT00183989

    Englisch

    Eligibility Mantle Cell Lymphoma NCT00183989

    1 Formulare  
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    pathologic diagnosis of non-hodgkin's lymphoma of the mantle cell sub-type lymphoma only, as determined by morphologic assessment and consistent immunophemotypic markers
    Beschreibung

    pathology mantle cell lymphoma

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0030664 (Pathology)
    SNOMED
    394595002
    UMLS CUI [1,2]
    C0334634 (Malignant lymphoma, lymphocytic, intermediate differentiation, diffuse)
    SNOMED
    74654000
    newly diagnosed and patients who have received prior treatment are eligible
    Beschreibung

    diagnosis, treatment

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0011900 (Diagnosis)
    SNOMED
    439401001
    LOINC
    LP30831-9
    UMLS CUI [2]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    measurable or evaluable disease
    Beschreibung

    measurable or evaluable disease

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1513041 (Measurable Disease)
    UMLS CUI [2]
    C1516986 (Evaluable Disease)
    karnofsky performance status greater or equal to 50%
    Beschreibung

    karnofsky

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0206065 (Karnofsky Performance Status)
    SNOMED
    273546003
    LOINC
    LP267177-6
    men and women, age greater or equal to 18 years old
    Beschreibung

    gender, age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    UMLS CUI [2]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    agc greater or equal to 1.0; platelets greater or equal to 75,000; hemoglobin greater or equal to 8.0 (unless because of lymphomatous infiltration of the marrow)
    Beschreibung

    granulocytes, platelets, hb

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0857490 (Granulocyte count)
    SNOMED
    118138007
    UMLS CUI [2]
    C0032181 (Platelet Count measurement)
    SNOMED
    61928009
    UMLS CUI [3]
    C0518015 (Hemoglobin measurement)
    creatinine less than 2.0; bilirubin less than 2.0; sgot less than 3 times upper limit of normal (unless elevations are due to lymphomatous involvement)
    Beschreibung

    creatinine, bilirubin, ast

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0201976 (Creatinine measurement, serum (procedure))
    SNOMED
    113075003
    UMLS CUI [2]
    C1278039 (Serum total bilirubin measurement)
    SNOMED
    313840000
    UMLS CUI [3]
    C0201899 (Aspartate aminotransferase measurement)
    SNOMED
    45896001
    women of child bearing potential must have negative pregnancy test within 14 days of study entry.
    Beschreibung

    pregnancy tes

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0032976 (Pregnancy Tests)
    SNOMED
    74036000
    signed informed consent
    Beschreibung

    informed consent

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    history of congestive heart failure or significant cardiac disease
    Beschreibung

    cardiac disease

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0018799 (Heart Diseases)
    SNOMED
    56265001
    prior exposure to either fludarabine or mitoxantrone. prior exposure to rituximab allowed
    Beschreibung

    fludarabine, mitoxantrone

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0059985 (fludarabine)
    SNOMED
    108763009
    UMLS CUI [2]
    C0026259 (mitoxantrone)
    SNOMED
    108791001
    active infection
    Beschreibung

    infection

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0009450 (Communicable Diseases)
    SNOMED
    189822004
    hiv seropositive
    Beschreibung

    hiv

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0019682 (HIV)
    SNOMED
    19030005
    LOINC
    LP17126-1
    pregnant or lactating females
    Beschreibung

    pregnant or lactating

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    second active malignancy, other than squamous cell skin cancer,in-situ cervical cancer, or history of other cancer diagnosed within the preceding 5 years
    Beschreibung

    malignancy

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    presence of psychological or emotional disorders which would make valid informed consent impossible
    Beschreibung

    mental disorders

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0004936 (Mental disorders)
    SNOMED
    74732009
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Eligibility Mantle Cell Lymphoma NCT00183989

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    pathology mantle cell lymphoma
    Item
    pathologic diagnosis of non-hodgkin's lymphoma of the mantle cell sub-type lymphoma only, as determined by morphologic assessment and consistent immunophemotypic markers
    boolean
    C0030664 (UMLS CUI [1,1])
    C0334634 (UMLS CUI [1,2])
    diagnosis, treatment
    Item
    newly diagnosed and patients who have received prior treatment are eligible
    boolean
    C0011900 (UMLS CUI [1])
    C0087111 (UMLS CUI [2])
    measurable or evaluable disease
    Item
    measurable or evaluable disease
    boolean
    C1513041 (UMLS CUI [1])
    C1516986 (UMLS CUI [2])
    karnofsky
    Item
    karnofsky performance status greater or equal to 50%
    boolean
    C0206065 (UMLS CUI [1])
    gender, age
    Item
    men and women, age greater or equal to 18 years old
    boolean
    C0079399 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    granulocytes, platelets, hb
    Item
    agc greater or equal to 1.0; platelets greater or equal to 75,000; hemoglobin greater or equal to 8.0 (unless because of lymphomatous infiltration of the marrow)
    boolean
    C0857490 (UMLS CUI [1])
    C0032181 (UMLS CUI [2])
    C0518015 (UMLS CUI [3])
    creatinine, bilirubin, ast
    Item
    creatinine less than 2.0; bilirubin less than 2.0; sgot less than 3 times upper limit of normal (unless elevations are due to lymphomatous involvement)
    boolean
    C0201976 (UMLS CUI [1])
    C1278039 (UMLS CUI [2])
    C0201899 (UMLS CUI [3])
    pregnancy tes
    Item
    women of child bearing potential must have negative pregnancy test within 14 days of study entry.
    boolean
    C0032976 (UMLS CUI [1])
    informed consent
    Item
    signed informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    cardiac disease
    Item
    history of congestive heart failure or significant cardiac disease
    boolean
    C0018799 (UMLS CUI [1])
    fludarabine, mitoxantrone
    Item
    prior exposure to either fludarabine or mitoxantrone. prior exposure to rituximab allowed
    boolean
    C0059985 (UMLS CUI [1])
    C0026259 (UMLS CUI [2])
    infection
    Item
    active infection
    boolean
    C0009450 (UMLS CUI [1])
    hiv
    Item
    hiv seropositive
    boolean
    C0019682 (UMLS CUI [1])
    pregnant or lactating
    Item
    pregnant or lactating females
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    malignancy
    Item
    second active malignancy, other than squamous cell skin cancer,in-situ cervical cancer, or history of other cancer diagnosed within the preceding 5 years
    boolean
    C0006826 (UMLS CUI [1])
    mental disorders
    Item
    presence of psychological or emotional disorders which would make valid informed consent impossible
    boolean
    C0004936 (UMLS CUI [1])
    Zum Seitenanfang zurückkehren 

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