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ID

35340

Descrizione

Efficacy and Safety of Bendamustine Plus Rituximab in Chronic Lympocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT02491398

collegamento

https://clinicaltrials.gov/show/NCT02491398

Keywords

versioni (1)
  1. 28/02/19 28/02/19 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

28 febbraio 2019

DOI

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Licenza

Creative Commons BY 4.0
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    Eligibility Chronic Lymphocytic Leukemia NCT02491398

    Inglese

    Eligibility Chronic Lymphocytic Leukemia NCT02491398

    1 moduli  
    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    diagnosis of cll / small lymphocytic lymphoma (cll/) according to the world health organisation (who) classification 2008.
    Descrizione

    Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1302547
    patients who were treated with first and second-line bendamustine plus rituximab (br) from january 2008 to december 2014 from european centres adhering to the gimema group and the eric group.
    Descrizione

    Bendamustine/rituximab First line treatment | Bendamustine/rituximab Second line treatment

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1328232
    UMLS CUI [1,2]
    C1708063
    UMLS CUI [2,1]
    C1328232
    UMLS CUI [2,2]
    C1710038
    previously untreated cll patients requiring therapy according to the nci criteria (hallek m et al, blood 2008 - appendix g) and treated with at least one cycle of br as first-line treatment.
    Descrizione

    Prior Therapy Absent | Chronic Lymphocytic Leukemia Treatment required for | bendamustine/rituximab Course Quantity

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463
    UMLS CUI [1,2]
    C0332197
    UMLS CUI [2,1]
    C0023434
    UMLS CUI [2,2]
    C0332121
    UMLS CUI [3,1]
    C1328232
    UMLS CUI [3,2]
    C0750729
    UMLS CUI [3,3]
    C1265611
    cll patients that received one previous line of treatment using alkylating agents and/or purine analogues with or without monoclonal antibodies, requiring second-line therapy according to the nci criteria (hallek m et al, blood 2008 - appendix g) and treated with at least one cycle of bendamustine and rituximab.
    Descrizione

    Prior Therapy Chronic Lymphocytic Leukemia | Alkylating Agents | Purine analog | Monoclonal Antibodies | Monoclonal Antibodies Absent | Patient need for Second line treatment | bendamustine/rituximab Course Quantity

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463
    UMLS CUI [1,2]
    C0023434
    UMLS CUI [2]
    C0002073
    UMLS CUI [3]
    C1268902
    UMLS CUI [4]
    C0003250
    UMLS CUI [5,1]
    C0003250
    UMLS CUI [5,2]
    C0332197
    UMLS CUI [6,1]
    C0686904
    UMLS CUI [6,2]
    C1710038
    UMLS CUI [7,1]
    C1328232
    UMLS CUI [7,2]
    C0750729
    UMLS CUI [7,3]
    C1265611
    age ≥ 18 years old.
    Descrizione

    Age

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    signed written informed consent according to ich/eu/gcp and national local law.
    Descrizione

    Informed Consent

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Descrizione

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patients who have received 2 or more lines of prior therapy.
    Descrizione

    Prior Therapy Quantity

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463
    UMLS CUI [1,2]
    C1265611
    patients with:
    Descrizione

    Patients Have

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C3539897
    transformation of cll into aggressive lymphomas (richter's syndrome). hiv infection. active and uncontrolled hcv and/or hbv infections or liver cirrhosis.
    Descrizione

    Chronic lymphocytic leukaemia transformation Aggressive Lymphoma | Richter's syndrome | HIV Infection | Hepatitis C Uncontrolled | Hepatitis B Uncontrolled | Liver Cirrhosis Uncontrolled

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1142081
    UMLS CUI [1,2]
    C1332225
    UMLS CUI [2]
    C0349631
    UMLS CUI [3]
    C0019693
    UMLS CUI [4,1]
    C0019196
    UMLS CUI [4,2]
    C0205318
    UMLS CUI [5,1]
    C0019163
    UMLS CUI [5,2]
    C0205318
    UMLS CUI [6,1]
    C0023890
    UMLS CUI [6,2]
    C0205318
    Ritorna all'inizio della pagina

    Similar models

    Eligibility Chronic Lymphocytic Leukemia NCT02491398

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
    Item
    diagnosis of cll / small lymphocytic lymphoma (cll/) according to the world health organisation (who) classification 2008.
    boolean
    C1302547 (UMLS CUI [1])
    Bendamustine/rituximab First line treatment | Bendamustine/rituximab Second line treatment
    Item
    patients who were treated with first and second-line bendamustine plus rituximab (br) from january 2008 to december 2014 from european centres adhering to the gimema group and the eric group.
    boolean
    C1328232 (UMLS CUI [1,1])
    C1708063 (UMLS CUI [1,2])
    C1328232 (UMLS CUI [2,1])
    C1710038 (UMLS CUI [2,2])
    Prior Therapy Absent | Chronic Lymphocytic Leukemia Treatment required for | bendamustine/rituximab Course Quantity
    Item
    previously untreated cll patients requiring therapy according to the nci criteria (hallek m et al, blood 2008 - appendix g) and treated with at least one cycle of br as first-line treatment.
    boolean
    C1514463 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    C0023434 (UMLS CUI [2,1])
    C0332121 (UMLS CUI [2,2])
    C1328232 (UMLS CUI [3,1])
    C0750729 (UMLS CUI [3,2])
    C1265611 (UMLS CUI [3,3])
    Prior Therapy Chronic Lymphocytic Leukemia | Alkylating Agents | Purine analog | Monoclonal Antibodies | Monoclonal Antibodies Absent | Patient need for Second line treatment | bendamustine/rituximab Course Quantity
    Item
    cll patients that received one previous line of treatment using alkylating agents and/or purine analogues with or without monoclonal antibodies, requiring second-line therapy according to the nci criteria (hallek m et al, blood 2008 - appendix g) and treated with at least one cycle of bendamustine and rituximab.
    boolean
    C1514463 (UMLS CUI [1,1])
    C0023434 (UMLS CUI [1,2])
    C0002073 (UMLS CUI [2])
    C1268902 (UMLS CUI [3])
    C0003250 (UMLS CUI [4])
    C0003250 (UMLS CUI [5,1])
    C0332197 (UMLS CUI [5,2])
    C0686904 (UMLS CUI [6,1])
    C1710038 (UMLS CUI [6,2])
    C1328232 (UMLS CUI [7,1])
    C0750729 (UMLS CUI [7,2])
    C1265611 (UMLS CUI [7,3])
    Age
    Item
    age ≥ 18 years old.
    boolean
    C0001779 (UMLS CUI [1])
    Informed Consent
    Item
    signed written informed consent according to ich/eu/gcp and national local law.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Prior Therapy Quantity
    Item
    patients who have received 2 or more lines of prior therapy.
    boolean
    C1514463 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    Patients Have
    Item
    patients with:
    boolean
    C0030705 (UMLS CUI [1,1])
    C3539897 (UMLS CUI [1,2])
    Chronic lymphocytic leukaemia transformation Aggressive Lymphoma | Richter's syndrome | HIV Infection | Hepatitis C Uncontrolled | Hepatitis B Uncontrolled | Liver Cirrhosis Uncontrolled
    Item
    transformation of cll into aggressive lymphomas (richter's syndrome). hiv infection. active and uncontrolled hcv and/or hbv infections or liver cirrhosis.
    boolean
    C1142081 (UMLS CUI [1,1])
    C1332225 (UMLS CUI [1,2])
    C0349631 (UMLS CUI [2])
    C0019693 (UMLS CUI [3])
    C0019196 (UMLS CUI [4,1])
    C0205318 (UMLS CUI [4,2])
    C0019163 (UMLS CUI [5,1])
    C0205318 (UMLS CUI [5,2])
    C0023890 (UMLS CUI [6,1])
    C0205318 (UMLS CUI [6,2])
    Ritorna all'inizio della pagina 

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