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ID

26002

Description

Safety and Efficacy of Bexxar Therapy in the Treatment of Relapsed/Residual B-Cell Lymphoma After Autologous Transplant; ODM derived from: https://clinicaltrials.gov/show/NCT00434629

Link

https://clinicaltrials.gov/show/NCT00434629

Keywords

Versions (2)
  1. 10/2/17 10/2/17 -
  2. 10/4/17 10/4/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 4, 2017

DOI

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License

Creative Commons BY 4.0
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    Eligibility B-Cell Lymphoma NCT00434629

    English

    Eligibility B-Cell Lymphoma NCT00434629

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    cd20 positive b-cell lymphoma
    Description

    B-Cell Lymphoma CD20 antigen positive

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0079731
    UMLS CUI [1,2]
    C3888518
    confirmed relapsed/refractory disease following autologous transplant
    Description

    Autologous hematopoietic stem cell transplant | Recurrent disease | Refractory Disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2193200
    UMLS CUI [2]
    C0277556
    UMLS CUI [3]
    C1514815
    age ≤ 75 years
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    performance status 0 or 1
    Description

    Performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1518965
    creatinine ≤ 1.5 or calculated creatinine clearance ≥ 60 ml/min
    Description

    Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    UMLS CUI [2]
    C2711451
    total bilirubin, ast, and alt ≤ 1.5 x upper limit of normal (unless bilirubin due to gilbert's)
    Description

    Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Exception Bilirubin Due to Gilbert Disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1278039
    UMLS CUI [2]
    C0201899
    UMLS CUI [3]
    C0201836
    UMLS CUI [4,1]
    C1705847
    UMLS CUI [4,2]
    C0005437
    UMLS CUI [4,3]
    C0678226
    UMLS CUI [4,4]
    C0017551
    no active cns disease
    Description

    CNS disorder Absent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0007682
    UMLS CUI [1,2]
    C0332197
    no detectable bone marrow involvement by lymphoma on histopathologic bone marrow examination
    Description

    Lymphoma involves bone marrow Undetectable Bone Marrow Examination

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1301440
    UMLS CUI [1,2]
    C3827727
    UMLS CUI [1,3]
    C0005957
    bone marrow cellularity ≥ 15% on histopathologic bone marrow examination
    Description

    Bone marrow cellularity Percentage Bone Marrow Examination

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1561532
    UMLS CUI [1,2]
    C0439165
    UMLS CUI [1,3]
    C0005957
    availability of adequate stored autologous stem cell product (≥ 2 x 106 cd34+
    Description

    Stem cell product Autologous CD34 positive Availability

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1706452
    UMLS CUI [1,2]
    C0439859
    UMLS CUI [1,3]
    C0882849
    UMLS CUI [1,4]
    C0470187
    cells/kg)
    Description

    ID.11

    Data type

    boolean

    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    active infection
    Description

    Communicable Disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009450
    pregnant woman are excluded from the study
    Description

    Pregnancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    subjects not using contraceptives are excluded from the study
    Description

    Contraceptive methods Lacking

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0700589
    UMLS CUI [1,2]
    C0332268
    anc ≤ 1,500/μl and/or platelet count ≤ 100,000/μl
    Description

    Absolute neutrophil count | Platelet Count measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0948762
    UMLS CUI [2]
    C0032181
    life expectancy of ≤ 2 months
    Description

    Life Expectancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    prior anti-b-cell radioimmunotherapy (e.g., zevalin or bexxar) [patients who have received prior anti-b-cell monoclonal antibody therapy (e.g., rituximab or epratuzumab) will not be excluded.]
    Description

    Radioimmunotherapy Against B cells | Zevalin | Bexxar | Monoclonal Antibody Therapy Against B cells allowed | Rituximab allowed | Epratuzumab allowed

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0085101
    UMLS CUI [1,2]
    C0521124
    UMLS CUI [1,3]
    C0004561
    UMLS CUI [2]
    C0919274
    UMLS CUI [3]
    C0919272
    UMLS CUI [4,1]
    C0279694
    UMLS CUI [4,2]
    C0521124
    UMLS CUI [4,3]
    C0004561
    UMLS CUI [4,4]
    C0683607
    UMLS CUI [5,1]
    C0393022
    UMLS CUI [5,2]
    C0683607
    UMLS CUI [6,1]
    C1120776
    UMLS CUI [6,2]
    C0683607
    prior total body radiation therapy
    Description

    Total body radiation therapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0948732
    positive human anti-mouse antibody (hama) testing
    Description

    Human anti-mouse antibody test Positive

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1868744
    UMLS CUI [1,2]
    C1514241
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    Similar models

    Eligibility B-Cell Lymphoma NCT00434629

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    B-Cell Lymphoma CD20 antigen positive
    Item
    cd20 positive b-cell lymphoma
    boolean
    C0079731 (UMLS CUI [1,1])
    C3888518 (UMLS CUI [1,2])
    Autologous hematopoietic stem cell transplant | Recurrent disease | Refractory Disease
    Item
    confirmed relapsed/refractory disease following autologous transplant
    boolean
    C2193200 (UMLS CUI [1])
    C0277556 (UMLS CUI [2])
    C1514815 (UMLS CUI [3])
    Age
    Item
    age ≤ 75 years
    boolean
    C0001779 (UMLS CUI [1])
    Performance status
    Item
    performance status 0 or 1
    boolean
    C1518965 (UMLS CUI [1])
    Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
    Item
    creatinine ≤ 1.5 or calculated creatinine clearance ≥ 60 ml/min
    boolean
    C0201976 (UMLS CUI [1])
    C2711451 (UMLS CUI [2])
    Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Exception Bilirubin Due to Gilbert Disease
    Item
    total bilirubin, ast, and alt ≤ 1.5 x upper limit of normal (unless bilirubin due to gilbert's)
    boolean
    C1278039 (UMLS CUI [1])
    C0201899 (UMLS CUI [2])
    C0201836 (UMLS CUI [3])
    C1705847 (UMLS CUI [4,1])
    C0005437 (UMLS CUI [4,2])
    C0678226 (UMLS CUI [4,3])
    C0017551 (UMLS CUI [4,4])
    CNS disorder Absent
    Item
    no active cns disease
    boolean
    C0007682 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    Lymphoma involves bone marrow Undetectable Bone Marrow Examination
    Item
    no detectable bone marrow involvement by lymphoma on histopathologic bone marrow examination
    boolean
    C1301440 (UMLS CUI [1,1])
    C3827727 (UMLS CUI [1,2])
    C0005957 (UMLS CUI [1,3])
    Bone marrow cellularity Percentage Bone Marrow Examination
    Item
    bone marrow cellularity ≥ 15% on histopathologic bone marrow examination
    boolean
    C1561532 (UMLS CUI [1,1])
    C0439165 (UMLS CUI [1,2])
    C0005957 (UMLS CUI [1,3])
    Stem cell product Autologous CD34 positive Availability
    Item
    availability of adequate stored autologous stem cell product (≥ 2 x 106 cd34+
    boolean
    C1706452 (UMLS CUI [1,1])
    C0439859 (UMLS CUI [1,2])
    C0882849 (UMLS CUI [1,3])
    C0470187 (UMLS CUI [1,4])
    ID.11
    Item
    cells/kg)
    boolean
    Item Group
    C0680251 (UMLS CUI)
    Communicable Disease
    Item
    active infection
    boolean
    C0009450 (UMLS CUI [1])
    Pregnancy
    Item
    pregnant woman are excluded from the study
    boolean
    C0032961 (UMLS CUI [1])
    Contraceptive methods Lacking
    Item
    subjects not using contraceptives are excluded from the study
    boolean
    C0700589 (UMLS CUI [1,1])
    C0332268 (UMLS CUI [1,2])
    Absolute neutrophil count | Platelet Count measurement
    Item
    anc ≤ 1,500/μl and/or platelet count ≤ 100,000/μl
    boolean
    C0948762 (UMLS CUI [1])
    C0032181 (UMLS CUI [2])
    Life Expectancy
    Item
    life expectancy of ≤ 2 months
    boolean
    C0023671 (UMLS CUI [1])
    Radioimmunotherapy Against B cells | Zevalin | Bexxar | Monoclonal Antibody Therapy Against B cells allowed | Rituximab allowed | Epratuzumab allowed
    Item
    prior anti-b-cell radioimmunotherapy (e.g., zevalin or bexxar) [patients who have received prior anti-b-cell monoclonal antibody therapy (e.g., rituximab or epratuzumab) will not be excluded.]
    boolean
    C0085101 (UMLS CUI [1,1])
    C0521124 (UMLS CUI [1,2])
    C0004561 (UMLS CUI [1,3])
    C0919274 (UMLS CUI [2])
    C0919272 (UMLS CUI [3])
    C0279694 (UMLS CUI [4,1])
    C0521124 (UMLS CUI [4,2])
    C0004561 (UMLS CUI [4,3])
    C0683607 (UMLS CUI [4,4])
    C0393022 (UMLS CUI [5,1])
    C0683607 (UMLS CUI [5,2])
    C1120776 (UMLS CUI [6,1])
    C0683607 (UMLS CUI [6,2])
    Total body radiation therapy
    Item
    prior total body radiation therapy
    boolean
    C0948732 (UMLS CUI [1])
    Human anti-mouse antibody test Positive
    Item
    positive human anti-mouse antibody (hama) testing
    boolean
    C1868744 (UMLS CUI [1,1])
    C1514241 (UMLS CUI [1,2])
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