0 Avaliações
ID

41201

Descrição

A Study of MabThera/Rituxan (Rituximab) in Combination With Fludarabine And Cyclophosphamide as Primary Therapy in Elderly Patients With Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01263704

Link

https://clinicaltrials.gov/show/NCT01263704

Palavras-chave

Versões (1)
  1. 12/07/2020 12/07/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

12 de julho de 2020

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility Lymphocytic Leukemia, Chronic NCT01263704

    Inglês

    Eligibility Lymphocytic Leukemia, Chronic NCT01263704

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    adult patients, >/= 65 years of age
    Descrição

    Adult | Age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001675
    UMLS CUI [2]
    C0001779
    previously untreated b-cell chronic lymphocytic leukemia (cll)
    Descrição

    B-cell chronic lymphocytic leukemia Untreated

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0475774
    UMLS CUI [1,2]
    C0332155
    binet stage c or active binet stage a and b disease
    Descrição

    Binet Staging System

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1511118
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    prior treatment for cll
    Descrição

    Prior Therapy Chronic Lymphocytic Leukemia

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463
    UMLS CUI [1,2]
    C0023434
    cll with transformation (richter's syndrome)
    Descrição

    Chronic Lymphocytic Leukemia | Richter's syndrome

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0023434
    UMLS CUI [2]
    C0349631
    suspected or known cns involvement of cll
    Descrição

    Central Nervous System Involvement Chronic Lymphocytic Leukemia Suspected | Central Nervous System Involvement Chronic Lymphocytic Leukemia

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C4050309
    UMLS CUI [1,2]
    C0023434
    UMLS CUI [1,3]
    C0750491
    UMLS CUI [2,1]
    C4050309
    UMLS CUI [2,2]
    C0023434
    impaired renal or hepatic function
    Descrição

    Renal Insufficiency | Liver Dysfunction

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1565489
    UMLS CUI [2]
    C0086565
    hiv positivity, active hepatitis b/c or hbv surface antigen positive, or any active or uncontrolled infections
    Descrição

    HIV Seropositivity | Hepatitis B | Hepatitis C | Hepatitis B surface antigen positive | Communicable Disease | Communicable Disease Uncontrolled

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0019699
    UMLS CUI [2]
    C0019163
    UMLS CUI [3]
    C0019196
    UMLS CUI [4]
    C0149709
    UMLS CUI [5]
    C0009450
    UMLS CUI [6,1]
    C0009450
    UMLS CUI [6,2]
    C0205318
    patients with anti-hbv core antibodies (past infection with hbv) but who are negative for hbvsag (either anti-hbs ab positive or negative) and are positive for hbv-dna by pcr analysis
    Descrição

    Antibody to hepatitis B core antigen | Hepatitis B In the past | Hepatitis B surface antigen negative | Hepatitis B surface antibody positive | Hepatitis B surface antigen negative | Hepatitis B DNA Positive Polymerase Chain Reaction

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0312631
    UMLS CUI [2,1]
    C0019163
    UMLS CUI [2,2]
    C1444637
    UMLS CUI [3]
    C0919711
    UMLS CUI [4]
    C0149708
    UMLS CUI [5]
    C0919711
    UMLS CUI [6,1]
    C5206277
    UMLS CUI [6,2]
    C0032520
    concomitant diseases requiring chronic steroid administration
    Descrição

    Comorbidity Requirement Steroid therapy chronic

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C0149783
    UMLS CUI [1,4]
    C0205191
    active second malignancy within the 2 years prior to study (except for non-melanoma skin cancer and in situ cervix or breast or prostate carcinoma)
    Descrição

    Second Primary Cancer | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of female breast | Exception Carcinoma in situ of prostate

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0751623
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0699893
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0851140
    UMLS CUI [4,1]
    C1705847
    UMLS CUI [4,2]
    C0686288
    UMLS CUI [5,1]
    C1705847
    UMLS CUI [5,2]
    C0154088
    ecog performance status >/= 3
    Descrição

    ECOG performance status

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1520224
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    Similar models

    Eligibility Lymphocytic Leukemia, Chronic NCT01263704

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Adult | Age
    Item
    adult patients, >/= 65 years of age
    boolean
    C0001675 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    B-cell chronic lymphocytic leukemia Untreated
    Item
    previously untreated b-cell chronic lymphocytic leukemia (cll)
    boolean
    C0475774 (UMLS CUI [1,1])
    C0332155 (UMLS CUI [1,2])
    Binet Staging System
    Item
    binet stage c or active binet stage a and b disease
    boolean
    C1511118 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Prior Therapy Chronic Lymphocytic Leukemia
    Item
    prior treatment for cll
    boolean
    C1514463 (UMLS CUI [1,1])
    C0023434 (UMLS CUI [1,2])
    Chronic Lymphocytic Leukemia | Richter's syndrome
    Item
    cll with transformation (richter's syndrome)
    boolean
    C0023434 (UMLS CUI [1])
    C0349631 (UMLS CUI [2])
    Central Nervous System Involvement Chronic Lymphocytic Leukemia Suspected | Central Nervous System Involvement Chronic Lymphocytic Leukemia
    Item
    suspected or known cns involvement of cll
    boolean
    C4050309 (UMLS CUI [1,1])
    C0023434 (UMLS CUI [1,2])
    C0750491 (UMLS CUI [1,3])
    C4050309 (UMLS CUI [2,1])
    C0023434 (UMLS CUI [2,2])
    Renal Insufficiency | Liver Dysfunction
    Item
    impaired renal or hepatic function
    boolean
    C1565489 (UMLS CUI [1])
    C0086565 (UMLS CUI [2])
    HIV Seropositivity | Hepatitis B | Hepatitis C | Hepatitis B surface antigen positive | Communicable Disease | Communicable Disease Uncontrolled
    Item
    hiv positivity, active hepatitis b/c or hbv surface antigen positive, or any active or uncontrolled infections
    boolean
    C0019699 (UMLS CUI [1])
    C0019163 (UMLS CUI [2])
    C0019196 (UMLS CUI [3])
    C0149709 (UMLS CUI [4])
    C0009450 (UMLS CUI [5])
    C0009450 (UMLS CUI [6,1])
    C0205318 (UMLS CUI [6,2])
    Antibody to hepatitis B core antigen | Hepatitis B In the past | Hepatitis B surface antigen negative | Hepatitis B surface antibody positive | Hepatitis B surface antigen negative | Hepatitis B DNA Positive Polymerase Chain Reaction
    Item
    patients with anti-hbv core antibodies (past infection with hbv) but who are negative for hbvsag (either anti-hbs ab positive or negative) and are positive for hbv-dna by pcr analysis
    boolean
    C0312631 (UMLS CUI [1])
    C0019163 (UMLS CUI [2,1])
    C1444637 (UMLS CUI [2,2])
    C0919711 (UMLS CUI [3])
    C0149708 (UMLS CUI [4])
    C0919711 (UMLS CUI [5])
    C5206277 (UMLS CUI [6,1])
    C0032520 (UMLS CUI [6,2])
    Comorbidity Requirement Steroid therapy chronic
    Item
    concomitant diseases requiring chronic steroid administration
    boolean
    C0009488 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C0149783 (UMLS CUI [1,3])
    C0205191 (UMLS CUI [1,4])
    Second Primary Cancer | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of female breast | Exception Carcinoma in situ of prostate
    Item
    active second malignancy within the 2 years prior to study (except for non-melanoma skin cancer and in situ cervix or breast or prostate carcinoma)
    boolean
    C0751623 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0699893 (UMLS CUI [2,2])
    C1705847 (UMLS CUI [3,1])
    C0851140 (UMLS CUI [3,2])
    C1705847 (UMLS CUI [4,1])
    C0686288 (UMLS CUI [4,2])
    C1705847 (UMLS CUI [5,1])
    C0154088 (UMLS CUI [5,2])
    ECOG performance status
    Item
    ecog performance status >/= 3
    boolean
    C1520224 (UMLS CUI [1])
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