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ID

16079

Description

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

Lien

https://clinicaltrials.gov/show/NCT00022971

Mots-clés

Versions (1)
  1. 28/06/2016 28/06/2016 -
Téléchargé le

28 juin 2016

DOI

Pour une demande vous connecter.

Licence

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

    Anglais

    Eligibility Diffuse Large B-cell Lymphoma NCT00022971

    1 Formulaires  
    Criteria
    Description

    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.
    Description

    diagnosis of b-cell lymphoma or waldenstroms cll

    Type de données

    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.
    Description

    confirmation of diagnosis

    Type de données

    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.
    Description

    prior therapy with systemic agents or rituximab

    Type de données

    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.
    Description

    age

    Type de données

    boolean

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

    ecog performance status

    Type de données

    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.
    Description

    organ function parameters

    Type de données

    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.
    Description

    informed consent

    Type de données

    boolean

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

    Exclusion Criteria

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

    pregnant or nursing, willing to use contraception

    Type de données

    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.
    Description

    prior apolizumab treatment

    Type de données

    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.
    Description

    cardiac, cerebrovascular or peripheral vascular disease

    Type de données

    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.
    Description

    active cns lymphoma

    Type de données

    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.
    Description

    chemotherapy or systemic steroid therapy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    UMLS CUI [2]
    C0149783 (Steroid therapy)
    SNOMED
    297279009
    Retour au début de la page

    Similar models

    Eligibility Diffuse Large B-cell Lymphoma NCT00022971

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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])
    Retour au début de la page 

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