ID

39085

Descrição

Study to Learn if 200mg Test Drug (Fostamatinib) Helps People With Large B-Cell Lymphoma,a Type of Blood Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01499303

Link

https://clinicaltrials.gov/show/NCT01499303

Palavras-chave

Versões (1)
  1. 29/11/2019 29/11/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

29 de novembro de 2019

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility Diffuse Large B-Cell Lymphoma NCT01499303

    Inglês

    Eligibility Diffuse Large B-Cell Lymphoma NCT01499303

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    aged at least 18 years of age.
    Descrição

    Age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    patients with relapsed or refractory diffuse large b-cell lymphoma who have previously received r-chop (or equivalent) chemo-immunotherapy and high dose chemotherapy with stem cell rescue, or who are ineligible for high dose therapy with stem cell rescue.
    Descrição

    Diffuse large B-cell lymphoma recurrent | Diffuse large B-cell lymphoma refractory | R-CHOP Regimen | Equivalent | High-Dose Chemotherapy with Autologous Stem Cell Transplant | Patients Ineligible High-Dose Chemotherapy with Autologous Stem Cell Transplant

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0855111
    UMLS CUI [2]
    C0855112
    UMLS CUI [3]
    C0393023
    UMLS CUI [4]
    C0205163
    UMLS CUI [5]
    C1512429
    UMLS CUI [6,1]
    C0030705
    UMLS CUI [6,2]
    C1512714
    UMLS CUI [6,3]
    C1512429
    measurable disease as defined by cheson et al 2007 criteria.
    Descrição

    Measurable Disease

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1513041
    one fresh pre-treatment excisional or core needle biopsy from suitable and accessible site.
    Descrição

    Pre treatment Excision biopsy Site Suitable | Pre treatment Core needle biopsy Site Suitable

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C2709094
    UMLS CUI [1,2]
    C0184921
    UMLS CUI [1,3]
    C1515974
    UMLS CUI [1,4]
    C3900053
    UMLS CUI [2,1]
    C2709094
    UMLS CUI [2,2]
    C1318309
    UMLS CUI [2,3]
    C1515974
    UMLS CUI [2,4]
    C3900053
    world health organization (who) performance status 0 to 1.
    Descrição

    WHO performance status scale

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1298650
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    treatment with nitrosurea, mitomycin c, investigational agents or study drugs w/in28 days of first dose of study treatment, any other chemotherapy, immunotherapy or anticancer agents w/in 3 weeks of first dose of study treatment, previous fostamatinib.
    Descrição

    Nitrosourea | Mitomycin | Investigational New Drugs | Chemotherapy | Immunotherapy | Antineoplastic Agents | fostamatinib

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0028210
    UMLS CUI [2]
    C0002475
    UMLS CUI [3]
    C0013230
    UMLS CUI [4]
    C0392920
    UMLS CUI [5]
    C0021083
    UMLS CUI [6]
    C0003392
    UMLS CUI [7]
    C2713632
    with the exception of alopecia, any unresolved toxicities from prior therapy or surgery greater than common terminology criteria for adverse events (ctcae) grade 1.
    Descrição

    Exception Alopecia | Prior Therapy Resulting in Toxicity CTCAE Grades | Operative Surgical Procedures Resulting in Toxicity CTCAE Grades | Resolution Lacking

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1705847
    UMLS CUI [1,2]
    C0002170
    UMLS CUI [2,1]
    C1514463
    UMLS CUI [2,2]
    C0332294
    UMLS CUI [2,3]
    C0600688
    UMLS CUI [2,4]
    C1516728
    UMLS CUI [3,1]
    C0543467
    UMLS CUI [3,2]
    C0332294
    UMLS CUI [3,3]
    C0600688
    UMLS CUI [3,4]
    C1516728
    UMLS CUI [4,1]
    C1514893
    UMLS CUI [4,2]
    C0332268
    uncontrolled hypertension (defined as >140mmhg systolic and/or > 90 mmhg diastolic at baseline with or without antihypertensive therapy.
    Descrição

    Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Antihypertensive therapy | Antihypertensive therapy Absent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1868885
    UMLS CUI [2]
    C0871470
    UMLS CUI [3]
    C0428883
    UMLS CUI [4]
    C0585941
    UMLS CUI [5,1]
    C0585941
    UMLS CUI [5,2]
    C0332197
    evidence of tuberculosis (tb).
    Descrição

    Tuberculosis

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0041296
    inadequate boen marrow reserve.
    Descrição

    Few mature neutrophils in the bone marrow

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2748959
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    Similar models

    Eligibility Diffuse Large B-Cell Lymphoma NCT01499303

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    aged at least 18 years of age.
    boolean
    C0001779 (UMLS CUI [1])
    Diffuse large B-cell lymphoma recurrent | Diffuse large B-cell lymphoma refractory | R-CHOP Regimen | Equivalent | High-Dose Chemotherapy with Autologous Stem Cell Transplant | Patients Ineligible High-Dose Chemotherapy with Autologous Stem Cell Transplant
    Item
    patients with relapsed or refractory diffuse large b-cell lymphoma who have previously received r-chop (or equivalent) chemo-immunotherapy and high dose chemotherapy with stem cell rescue, or who are ineligible for high dose therapy with stem cell rescue.
    boolean
    C0855111 (UMLS CUI [1])
    C0855112 (UMLS CUI [2])
    C0393023 (UMLS CUI [3])
    C0205163 (UMLS CUI [4])
    C1512429 (UMLS CUI [5])
    C0030705 (UMLS CUI [6,1])
    C1512714 (UMLS CUI [6,2])
    C1512429 (UMLS CUI [6,3])
    Measurable Disease
    Item
    measurable disease as defined by cheson et al 2007 criteria.
    boolean
    C1513041 (UMLS CUI [1])
    Pre treatment Excision biopsy Site Suitable | Pre treatment Core needle biopsy Site Suitable
    Item
    one fresh pre-treatment excisional or core needle biopsy from suitable and accessible site.
    boolean
    C2709094 (UMLS CUI [1,1])
    C0184921 (UMLS CUI [1,2])
    C1515974 (UMLS CUI [1,3])
    C3900053 (UMLS CUI [1,4])
    C2709094 (UMLS CUI [2,1])
    C1318309 (UMLS CUI [2,2])
    C1515974 (UMLS CUI [2,3])
    C3900053 (UMLS CUI [2,4])
    WHO performance status scale
    Item
    world health organization (who) performance status 0 to 1.
    boolean
    C1298650 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Nitrosourea | Mitomycin | Investigational New Drugs | Chemotherapy | Immunotherapy | Antineoplastic Agents | fostamatinib
    Item
    treatment with nitrosurea, mitomycin c, investigational agents or study drugs w/in28 days of first dose of study treatment, any other chemotherapy, immunotherapy or anticancer agents w/in 3 weeks of first dose of study treatment, previous fostamatinib.
    boolean
    C0028210 (UMLS CUI [1])
    C0002475 (UMLS CUI [2])
    C0013230 (UMLS CUI [3])
    C0392920 (UMLS CUI [4])
    C0021083 (UMLS CUI [5])
    C0003392 (UMLS CUI [6])
    C2713632 (UMLS CUI [7])
    Exception Alopecia | Prior Therapy Resulting in Toxicity CTCAE Grades | Operative Surgical Procedures Resulting in Toxicity CTCAE Grades | Resolution Lacking
    Item
    with the exception of alopecia, any unresolved toxicities from prior therapy or surgery greater than common terminology criteria for adverse events (ctcae) grade 1.
    boolean
    C1705847 (UMLS CUI [1,1])
    C0002170 (UMLS CUI [1,2])
    C1514463 (UMLS CUI [2,1])
    C0332294 (UMLS CUI [2,2])
    C0600688 (UMLS CUI [2,3])
    C1516728 (UMLS CUI [2,4])
    C0543467 (UMLS CUI [3,1])
    C0332294 (UMLS CUI [3,2])
    C0600688 (UMLS CUI [3,3])
    C1516728 (UMLS CUI [3,4])
    C1514893 (UMLS CUI [4,1])
    C0332268 (UMLS CUI [4,2])
    Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Antihypertensive therapy | Antihypertensive therapy Absent
    Item
    uncontrolled hypertension (defined as >140mmhg systolic and/or > 90 mmhg diastolic at baseline with or without antihypertensive therapy.
    boolean
    C1868885 (UMLS CUI [1])
    C0871470 (UMLS CUI [2])
    C0428883 (UMLS CUI [3])
    C0585941 (UMLS CUI [4])
    C0585941 (UMLS CUI [5,1])
    C0332197 (UMLS CUI [5,2])
    Tuberculosis
    Item
    evidence of tuberculosis (tb).
    boolean
    C0041296 (UMLS CUI [1])
    Few mature neutrophils in the bone marrow
    Item
    inadequate boen marrow reserve.
    boolean
    C2748959 (UMLS CUI [1])
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