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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

Versioner (1)
  1. 2016-06-28 2016-06-28 -
Uppladdad den

28 juni 2016

DOI

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Creative Commons BY 4.0
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    Eligibility Diffuse Large B-cell Lymphoma NCT00022971

    Engelsk

    Eligibility Diffuse Large B-cell Lymphoma NCT00022971

    1 Formulär  
    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
    UMLS CUI [2]
    C0024419
    confirmation of diagnosis in laboratory of pathology, nci or osu.
    Beskrivning

    confirmation of diagnosis

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0011911
    UMLS CUI [2,1]
    C0348026
    UMLS CUI [2,2]
    C1513882
    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
    UMLS CUI [1,2]
    C1515119
    UMLS CUI [2,1]
    C1514463
    UMLS CUI [2,2]
    C4047978
    age greater than 18 years.
    Beskrivning

    age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    ecog performance status less than or equal to 2.
    Beskrivning

    ecog performance status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1632812
    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
    UMLS CUI [2]
    C0005821
    UMLS CUI [3]
    C0201976
    UMLS CUI [4]
    C0373595
    UMLS CUI [5]
    C0201836
    UMLS CUI [6]
    C1278039
    provides informed consent.
    Beskrivning

    informed consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    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
    UMLS CUI [1,2]
    C0006147
    UMLS CUI [1,3]
    C0700589
    prior apolizumab treatment.
    Beskrivning

    prior apolizumab treatment

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463
    UMLS CUI [1,2]
    C1122758
    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
    UMLS CUI [1,2]
    C0007820
    UMLS CUI [1,3]
    C3841707
    active cns lymphoma.
    Beskrivning

    active cns lymphoma

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0742472
    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
    UMLS CUI [2]
    C0149783
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    Similar models

    Eligibility Diffuse Large B-cell Lymphoma NCT00022971

    1 Formulär
    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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