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ID

13240

Beskrivning

Treatment of Non-Hodgkin's Lymphoma With 90Y-hLL2 IgG; ODM derived from: https://clinicaltrials.gov/show/NCT00061425

Länk

https://clinicaltrials.gov/show/NCT00061425

Nyckelord

Versioner (1)
  1. 2016-01-25 2016-01-25 -
Uppladdad den

25 januari 2016

DOI

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Licens

Creative Commons BY 4.0
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    Eligibility Non-Hodgkin's Lymphoma NCT00061425

    Engelsk

    Eligibility Non-Hodgkin's Lymphoma NCT00061425

    1 Formulär  
    Criteria
    Beskrivning

    Criteria

    histological or cytological diagnosis of b-cell lymphoma, and has failed at least one regimen of standard chemotherapy. (all histological grades of nhl will be eligible for this trial.)
    Beskrivning

    b-cell lymphoma, chemotherapy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0079731
    UMLS CUI [2]
    C0392920
    measureable via ct, with at least one lesion > or = 1.5cm in one or both dimensions. (splenic tumors in absence of other tumors will not qualify.)
    Beskrivning

    measureable

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1513041
    radiological studies (ie - ct) must be performed within 4 weeks prior to study start.
    Beskrivning

    radiologic exam

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2985535
    acceptable tumor burden that will allow adequate follow-up and evaluation.
    Beskrivning

    follow-up, evaluation

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1522577
    UMLS CUI [2]
    C0220825
    less that 25% bone marrow involvement, determined by bone marrow biopsy.
    Beskrivning

    bone marrow

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0005953
    at least 4 weeks beyond any major surgery. at least 4 weeks beyond any radiation therapy to the index lesion, and has recovered from radiation-induced toxicity.
    Beskrivning

    major surgery, radiation therapy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0679637
    UMLS CUI [2]
    C1522449
    at least 4 weeks beyond chemotherapy and/or immunotherapy. at least 2 weeks beyond corticosteriod(s) use and blood counts are with laboratory criteria.
    Beskrivning

    chemotherapy, immunotherapy, corticosteroids

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    UMLS CUI [2]
    C0021083
    UMLS CUI [3]
    C0001617
    must have karnofsky score >70% (or equivalent, ecog 0-2) with expected survival of at least 6 months.
    Beskrivning

    karnofsky

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0206065
    serum creatinine < or = 1.5mg/dl or creatinine clearance > or = 50ml/min.
    Beskrivning

    creatinine, creatinine clearance

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    UMLS CUI [2]
    C0373595
    serum bilirubin < or = 2mg/dl.
    Beskrivning

    bilirubin

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1278039
    hemoglobin > or = 10 g/dl; wbc > or = 3000/mm3; granulocyte count > or = 150/mm3; platelet count > or = 100,000/mm3 with out transfusions or cytokines for at least 30 days prior to study.
    Beskrivning

    hemoglobin, granulocyte count, transfusions, cytokines

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0518015
    UMLS CUI [2]
    C0857490
    UMLS CUI [3]
    C0032181
    UMLS CUI [4]
    C1879316
    UMLS CUI [5]
    C0199974
    immunomedics elisa assay of hahll2 < 100ng/ml for those with prior history of monoclonal antibody infusions.
    Beskrivning

    human anti-human antibodies

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3641682
    cognizant informed consent.
    Beskrivning

    informed consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
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    Similar models

    Eligibility Non-Hodgkin's Lymphoma NCT00061425

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    b-cell lymphoma, chemotherapy
    Item
    histological or cytological diagnosis of b-cell lymphoma, and has failed at least one regimen of standard chemotherapy. (all histological grades of nhl will be eligible for this trial.)
    boolean
    C0079731 (UMLS CUI [1])
    C0392920 (UMLS CUI [2])
    measureable
    Item
    measureable via ct, with at least one lesion > or = 1.5cm in one or both dimensions. (splenic tumors in absence of other tumors will not qualify.)
    boolean
    C1513041 (UMLS CUI [1])
    radiologic exam
    Item
    radiological studies (ie - ct) must be performed within 4 weeks prior to study start.
    boolean
    C2985535 (UMLS CUI [1])
    follow-up, evaluation
    Item
    acceptable tumor burden that will allow adequate follow-up and evaluation.
    boolean
    C1522577 (UMLS CUI [1])
    C0220825 (UMLS CUI [2])
    bone marrow
    Item
    less that 25% bone marrow involvement, determined by bone marrow biopsy.
    boolean
    C0005953 (UMLS CUI [1])
    major surgery, radiation therapy
    Item
    at least 4 weeks beyond any major surgery. at least 4 weeks beyond any radiation therapy to the index lesion, and has recovered from radiation-induced toxicity.
    boolean
    C0679637 (UMLS CUI [1])
    C1522449 (UMLS CUI [2])
    chemotherapy, immunotherapy, corticosteroids
    Item
    at least 4 weeks beyond chemotherapy and/or immunotherapy. at least 2 weeks beyond corticosteriod(s) use and blood counts are with laboratory criteria.
    boolean
    C0392920 (UMLS CUI [1])
    C0021083 (UMLS CUI [2])
    C0001617 (UMLS CUI [3])
    karnofsky
    Item
    must have karnofsky score >70% (or equivalent, ecog 0-2) with expected survival of at least 6 months.
    boolean
    C0206065 (UMLS CUI [1])
    creatinine, creatinine clearance
    Item
    serum creatinine < or = 1.5mg/dl or creatinine clearance > or = 50ml/min.
    boolean
    C0201976 (UMLS CUI [1])
    C0373595 (UMLS CUI [2])
    bilirubin
    Item
    serum bilirubin < or = 2mg/dl.
    boolean
    C1278039 (UMLS CUI [1])
    hemoglobin, granulocyte count, transfusions, cytokines
    Item
    hemoglobin > or = 10 g/dl; wbc > or = 3000/mm3; granulocyte count > or = 150/mm3; platelet count > or = 100,000/mm3 with out transfusions or cytokines for at least 30 days prior to study.
    boolean
    C0518015 (UMLS CUI [1])
    C0857490 (UMLS CUI [2])
    C0032181 (UMLS CUI [3])
    C1879316 (UMLS CUI [4])
    C0199974 (UMLS CUI [5])
    human anti-human antibodies
    Item
    immunomedics elisa assay of hahll2 < 100ng/ml for those with prior history of monoclonal antibody infusions.
    boolean
    C3641682 (UMLS CUI [1])
    informed consent
    Item
    cognizant informed consent.
    boolean
    C0021430 (UMLS CUI [1])
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