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ID

16079

Beskrivning

Combination Antibody Therapy for Relapsed Lymphoma and Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00022971

Länk

https://clinicaltrials.gov/show/NCT00022971

Nyckelord

  1. 2016-06-28 2016-06-28 -
Uppladdad den

28 juni 2016

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility Diffuse Large B-cell Lymphoma NCT00022971

    Eligibility Diffuse Large B-cell Lymphoma NCT00022971

    Criteria
    Beskrivning

    Criteria

    diagnosis of b-cell lymphoma, waldenstrom's cll with surface expression of both cd20 and 1d10 antigen by immunohistochemistry (ihc) or fluorescence of activated cell sorting (facs) with anti-cd20 and 1d10 antibody. positive 1d10 expression in a facs assay is defined as more than 2 times the mean fluorescence intensity (mfi) of the control antibody by facs or greater than 20% of cells 1d10+ by ihc.
    Beskrivning

    diagnosis of b-cell lymphoma or waldenstroms cll

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0079731 (B-Cell Lymphomas)
    SNOMED
    109979007
    UMLS CUI [2]
    C0024419 (Waldenstrom Macroglobulinemia)
    SNOMED
    190818004
    confirmation of diagnosis in laboratory of pathology, nci or osu.
    Beskrivning

    confirmation of diagnosis

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0011911 (Laboratory Diagnosis)
    SNOMED
    46159000
    UMLS CUI [2,1]
    C0348026 (Diagnostic)
    SNOMED
    261004008
    LOINC
    LP249287-6
    UMLS CUI [2,2]
    C1513882 (National Cancer Institute)
    LOINC
    LA4524-0
    prior therapy with at least one systemic treatment, and not a candidate for potentially curative (i.e., transplant) treatment at the time of study entry. prior treatment with rituximab greater than or equal to 1 month ago is permitted.
    Beskrivning

    prior therapy with systemic agents or rituximab

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463 (Prior Therapy)
    UMLS CUI [1,2]
    C1515119 (Systemic Therapy)
    UMLS CUI [2,1]
    C1514463 (Prior Therapy)
    UMLS CUI [2,2]
    C4047978 (Rituximab therapy)
    SNOMED
    724159000
    age greater than 18 years.
    Beskrivning

    age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    ecog performance status less than or equal to 2.
    Beskrivning

    ecog performance status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1632812 (ECOG performance status grade)
    LOINC
    MTHU025134
    major organ function: anc greater than or equal to 500/microliter, platelet greater than or equal 25,000/microliter, creatinine less than or equal to 1.5 mg/dl or creatinine clearance greater than 60 cc/min; sgpt less than 5 x upper limit of normal; bilirubin less than 2 mg/dl (total) except less than 5 mg/dl in patients with gilbert's syndrome as defined by greater than 80% unconjugated; unless impairment due to organ involvement by lymphoma.
    Beskrivning

    organ function parameters

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0948762 (Absolute neutrophil count)
    UMLS CUI [2]
    C0005821 (Blood Platelets)
    SNOMED
    16378004
    LOINC
    LP70360-0
    UMLS CUI [3]
    C0201976 (Creatinine measurement, serum (procedure))
    SNOMED
    113075003
    UMLS CUI [4]
    C0373595 (Creatinine clearance measurement)
    SNOMED
    167181009
    UMLS CUI [5]
    C0201836 (Alanine aminotransferase measurement)
    SNOMED
    34608000
    UMLS CUI [6]
    C1278039 (Serum total bilirubin measurement)
    SNOMED
    313840000
    provides informed consent.
    Beskrivning

    informed consent

    Datatyp

    boolean

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

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    pregnancy or nursing. both male and female patients must be willing to use adequate contraception.
    Beskrivning

    pregnant or nursing, willing to use contraception

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [1,2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    UMLS CUI [1,3]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    prior apolizumab treatment.
    Beskrivning

    prior apolizumab treatment

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463 (Prior Therapy)
    UMLS CUI [1,2]
    C1122758 (apolizumab)
    sactive cardiac disease, cerebrovascular disease or peripheral arterial vascular disease.
    Beskrivning

    cardiac, cerebrovascular or peripheral vascular disease

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0007222 (Cardiovascular Diseases)
    SNOMED
    49601007
    UMLS CUI [1,2]
    C0007820 (Cerebrovascular Disorders)
    SNOMED
    62914000
    UMLS CUI [1,3]
    C3841707 (Peripheral vascular disease (PVD) or peripheral arterial disease (PAD))
    LOINC
    LA18399-8
    active cns lymphoma.
    Beskrivning

    active cns lymphoma

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0742472 (undefined)
    systemic cytotoxic chemotherapy within 3 weeks of enrollment or systemic steroids (except stable doses less than 10 mg/day) within 1 week of enrollment.
    Beskrivning

    chemotherapy or systemic steroid therapy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    UMLS CUI [2]
    C0149783 (Steroid therapy)
    SNOMED
    297279009

    Similar models

    Eligibility Diffuse Large B-cell Lymphoma NCT00022971

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    diagnosis of b-cell lymphoma or waldenstroms cll
    Item
    diagnosis of b-cell lymphoma, waldenstrom's cll with surface expression of both cd20 and 1d10 antigen by immunohistochemistry (ihc) or fluorescence of activated cell sorting (facs) with anti-cd20 and 1d10 antibody. positive 1d10 expression in a facs assay is defined as more than 2 times the mean fluorescence intensity (mfi) of the control antibody by facs or greater than 20% of cells 1d10+ by ihc.
    boolean
    C0079731 (UMLS CUI [1])
    C0024419 (UMLS CUI [2])
    confirmation of diagnosis
    Item
    confirmation of diagnosis in laboratory of pathology, nci or osu.
    boolean
    C0011911 (UMLS CUI [1])
    C0348026 (UMLS CUI [2,1])
    C1513882 (UMLS CUI [2,2])
    prior therapy with systemic agents or rituximab
    Item
    prior therapy with at least one systemic treatment, and not a candidate for potentially curative (i.e., transplant) treatment at the time of study entry. prior treatment with rituximab greater than or equal to 1 month ago is permitted.
    boolean
    C1514463 (UMLS CUI [1,1])
    C1515119 (UMLS CUI [1,2])
    C1514463 (UMLS CUI [2,1])
    C4047978 (UMLS CUI [2,2])
    age
    Item
    age greater than 18 years.
    boolean
    C0001779 (UMLS CUI [1])
    ecog performance status
    Item
    ecog performance status less than or equal to 2.
    boolean
    C1632812 (UMLS CUI [1])
    organ function parameters
    Item
    major organ function: anc greater than or equal to 500/microliter, platelet greater than or equal 25,000/microliter, creatinine less than or equal to 1.5 mg/dl or creatinine clearance greater than 60 cc/min; sgpt less than 5 x upper limit of normal; bilirubin less than 2 mg/dl (total) except less than 5 mg/dl in patients with gilbert's syndrome as defined by greater than 80% unconjugated; unless impairment due to organ involvement by lymphoma.
    boolean
    C0948762 (UMLS CUI [1])
    C0005821 (UMLS CUI [2])
    C0201976 (UMLS CUI [3])
    C0373595 (UMLS CUI [4])
    C0201836 (UMLS CUI [5])
    C1278039 (UMLS CUI [6])
    informed consent
    Item
    provides informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    pregnant or nursing, willing to use contraception
    Item
    pregnancy or nursing. both male and female patients must be willing to use adequate contraception.
    boolean
    C0032961 (UMLS CUI [1,1])
    C0006147 (UMLS CUI [1,2])
    C0700589 (UMLS CUI [1,3])
    prior apolizumab treatment
    Item
    prior apolizumab treatment.
    boolean
    C1514463 (UMLS CUI [1,1])
    C1122758 (UMLS CUI [1,2])
    cardiac, cerebrovascular or peripheral vascular disease
    Item
    sactive cardiac disease, cerebrovascular disease or peripheral arterial vascular disease.
    boolean
    C0007222 (UMLS CUI [1,1])
    C0007820 (UMLS CUI [1,2])
    C3841707 (UMLS CUI [1,3])
    active cns lymphoma
    Item
    active cns lymphoma.
    boolean
    C0742472 (UMLS CUI [1])
    chemotherapy or systemic steroid therapy
    Item
    systemic cytotoxic chemotherapy within 3 weeks of enrollment or systemic steroids (except stable doses less than 10 mg/day) within 1 week of enrollment.
    boolean
    C0392920 (UMLS CUI [1])
    C0149783 (UMLS CUI [2])

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