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ID

39085

Description

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

Keywords

Versions (1)
  1. 11/29/19 11/29/19 -
Copyright Holder

See clinicaltrials.gov

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November 29, 2019

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

    English

    Eligibility Diffuse Large B-Cell Lymphoma NCT01499303

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    aged at least 18 years of age.
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    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.
    Description

    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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0855111 (Diffuse large B-cell lymphoma recurrent)
    UMLS CUI [2]
    C0855112 (Diffuse large B-cell lymphoma refractory)
    UMLS CUI [3]
    C0393023 (R-CHOP Regimen)
    UMLS CUI [4]
    C0205163 (Equal)
    SNOMED
    258726008
    UMLS CUI [5]
    C1512429 (High-Dose Chemotherapy with Autologous Stem Cell Transplant)
    UMLS CUI [6,1]
    C0030705 (Patients)
    SNOMED
    116154003
    UMLS CUI [6,2]
    C1512714 (Ineligibility)
    UMLS CUI [6,3]
    C1512429 (High-Dose Chemotherapy with Autologous Stem Cell Transplant)
    measurable disease as defined by cheson et al 2007 criteria.
    Description

    Measurable Disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1513041 (Measurable Disease)
    one fresh pre-treatment excisional or core needle biopsy from suitable and accessible site.
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2709094 (pre treatment)
    LOINC
    LP94463-4
    UMLS CUI [1,2]
    C0184921 (Excision biopsy)
    SNOMED
    8889005
    UMLS CUI [1,3]
    C1515974 (Anatomic Site)
    UMLS CUI [1,4]
    C3900053 (Amenable)
    UMLS CUI [2,1]
    C2709094 (pre treatment)
    LOINC
    LP94463-4
    UMLS CUI [2,2]
    C1318309 (Core needle biopsy)
    SNOMED
    9911007
    UMLS CUI [2,3]
    C1515974 (Anatomic Site)
    UMLS CUI [2,4]
    C3900053 (Amenable)
    world health organization (who) performance status 0 to 1.
    Description

    WHO performance status scale

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1298650 (WHO performance status scale)
    SNOMED
    373801008
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    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.
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0028210 (Nitrosourea Compounds)
    SNOMED
    349843000
    UMLS CUI [2]
    C0002475 (mitomycin)
    SNOMED
    59240002
    UMLS CUI [3]
    C0013230 (Investigational New Drugs)
    UMLS CUI [4]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    UMLS CUI [5]
    C0021083 (Immunotherapy)
    SNOMED
    76334006
    UMLS CUI [6]
    C0003392 (Antineoplastic Agents)
    SNOMED
    27867009
    UMLS CUI [7]
    C2713632 (fostamatinib)
    SNOMED
    772039004
    with the exception of alopecia, any unresolved toxicities from prior therapy or surgery greater than common terminology criteria for adverse events (ctcae) grade 1.
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1705847 (Exception - Property or Attribute)
    UMLS CUI [1,2]
    C0002170 (Alopecia)
    SNOMED
    56317004
    UMLS CUI [2,1]
    C1514463 (Prior Therapy)
    UMLS CUI [2,2]
    C0332294 (Resulting in)
    SNOMED
    79409006
    UMLS CUI [2,3]
    C0600688 (Toxic effect)
    SNOMED
    75478009
    UMLS CUI [2,4]
    C1516728 (National Cancer Institute common terminology criteria for adverse events)
    SNOMED
    446391000124101
    UMLS CUI [3,1]
    C0543467 (Operative Surgical Procedures)
    SNOMED
    257556004
    LOINC
    LP7802-4
    UMLS CUI [3,2]
    C0332294 (Resulting in)
    SNOMED
    79409006
    UMLS CUI [3,3]
    C0600688 (Toxic effect)
    SNOMED
    75478009
    UMLS CUI [3,4]
    C1516728 (National Cancer Institute common terminology criteria for adverse events)
    SNOMED
    446391000124101
    UMLS CUI [4,1]
    C1514893 (physiologic resolution)
    UMLS CUI [4,2]
    C0332268 (Lacking)
    SNOMED
    41277001
    uncontrolled hypertension (defined as >140mmhg systolic and/or > 90 mmhg diastolic at baseline with or without antihypertensive therapy.
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1868885 (Uncontrolled hypertension)
    UMLS CUI [2]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    UMLS CUI [3]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    UMLS CUI [4]
    C0585941 (Antihypertensive therapy)
    SNOMED
    308116003
    UMLS CUI [5,1]
    C0585941 (Antihypertensive therapy)
    SNOMED
    308116003
    UMLS CUI [5,2]
    C0332197 (Absent)
    SNOMED
    2667000
    LOINC
    LA9634-2
    evidence of tuberculosis (tb).
    Description

    Tuberculosis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0041296 (Tuberculosis)
    SNOMED
    373576009
    LOINC
    LP28599-6
    inadequate boen marrow reserve.
    Description

    Few mature neutrophils in the bone marrow

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2748959 (Few mature neutrophils in the bone marrow)
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    Similar models

    Eligibility Diffuse Large B-Cell Lymphoma NCT01499303

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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