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42075

Description

Study ID: 104512 Clinical Study ID: 104512 Study Title: Phase I, Dose-Escalation Study of Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma With More Than 25% Bone Marrow Involvement Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992758 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Iodine-131 Anti-B1 Antibody Trade Name: Tositumomab Study Indication: Lymphoma, Non-Hodgkin

Keywords

Versions (2)
  1. 3/18/21 3/18/21 -
  2. 3/18/21 3/18/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 18, 2021

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License

Creative Commons BY 4.0
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    Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma NCT00992758

    English

    Patient Enrollment/ Patient Eligibility - Demographics; General Medical History; Prior Therapy; History of Lymphoma

    1 forms  
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Site Number
    Description

    Site Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2825164
    UMLS CUI [1,2]
    C0237753
    Patient Number
    Description

    Patient Number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C1300638
    Patient Initials
    Description

    Patient Initials

    Data type

    text

    Alias
    UMLS CUI [1]
    C2986440
    Demographics (Enrollment)
    Description

    Demographics (Enrollment)

    Alias
    UMLS CUI-1
    C1704791
    UMLS CUI-2
    C1516879
    Patient Body Weight
    Description

    Patient Body Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Patient Height
    Description

    Patient Height

    Data type

    integer

    Measurement units
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Date of birth
    Description

    Date of birth

    Data type

    date

    Alias
    UMLS CUI [1]
    C0421451
    Gender
    Description

    Gender

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0079399
    Investigator Signature
    Description

    Investigator Signature

    Alias
    UMLS CUI-1
    C2346576
    Investigator Signature
    Description

    Investigator Signature

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Investigator Signature Date
    Description

    Investigator Signature Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    For Coulter Use Only
    Description

    For Coulter Use Only

    Alias
    UMLS CUI-1
    C3846158
    Patient Enrollment Authorized by
    Description

    Patient Enrollment Authorized by

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1555472
    UMLS CUI [1,2]
    C2700391
    UMLS CUI [1,3]
    C4041024
    Enrollment Date
    Description

    Enrollment Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0679646
    UMLS CUI [1,3]
    C1516879
    Approved Dose
    Description

    Approved Dose

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0205540
    Other approved dose
    Description

    Other approved dose

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0205540
    UMLS CUI [1,3]
    C0205394
    Adjust mCi dose for obesity
    Description

    Adjust mCi dose for obesity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1707811
    UMLS CUI [1,2]
    C0028754
    Demographics (General Medical History)
    Description

    Demographics (General Medical History)

    Alias
    UMLS CUI-1
    C1704791
    UMLS CUI-2
    C0262926
    Date of Birth
    Description

    Date of Birth

    Data type

    date

    Alias
    UMLS CUI [1]
    C0421451
    Gender
    Description

    Gender

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0079399
    Ethnic Origin
    Description

    Ethnic Origin

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0015031
    Other Ethnic Origin
    Description

    Other Ethnic Origin

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0015031
    UMLS CUI [1,2]
    C0205394
    Medical History Date
    Description

    Medical History Date

    Alias
    UMLS CUI-1
    C0262926
    UMLS CUI-2
    C0011008
    Medical History Date
    Description

    Medical History Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0011008
    General Medical History
    Description

    General Medical History

    Alias
    UMLS CUI-1
    C0262926
    Diagnosis/Condition
    Description

    Diagnosis/Condition

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0011900
    UMLS CUI [1,2]
    C0012634
    Date of Disease Onset
    Description

    Date of Disease Onset

    Data type

    partialDate

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0574845
    Disease Status
    Description

    Disease Status

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0449438
    Prior Therapy
    Description

    Prior Therapy

    Alias
    UMLS CUI-1
    C1514463
    Drugs
    Description

    Please report all prior therapies for NHL (i.e., chemotherapy, immunotherapy, steroidal therapy).

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013227
    Therapy Start Date
    Description

    Therapy Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C3173309
    Therapy Stop Date
    Description

    Therapy Stop Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1531784
    Number of Therapy Cycles
    Description

    Number of Therapy Cycles

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0750480
    Therapeutic Outcome
    Description

    Therapeutic Outcome

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C1547647
    Duration of Response
    Description

    Duration of Response

    Data type

    integer

    Measurement units
    • months
    Alias
    UMLS CUI [1]
    C0237585
    months
    Prior Radiation Therapy
    Description

    Prior Radiation Therapy

    Alias
    UMLS CUI-1
    C0279134
    Radiation Therapy Start Date
    Description

    Radiation Therapy Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1522449
    UMLS CUI [1,2]
    C0808070
    Radiation Therapy Stop Date
    Description

    Radiation Therapy Stop Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1522449
    UMLS CUI [1,2]
    C0806020
    Radiation Therapy Total Dose
    Description

    Radiation Therapy Total Dose

    Data type

    integer

    Measurement units
    • cGy
    Alias
    UMLS CUI [1]
    C2919490
    cGy
    Radiation Therapy Location
    Description

    Sites Treated

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1522449
    UMLS CUI [1,2]
    C0450429
    History of Lymphoma
    Description

    History of Lymphoma

    Alias
    UMLS CUI-1
    C0024299
    UMLS CUI-2
    C0262926
    Date of Diagnosis
    Description

    Date of Diagnosis

    Data type

    date

    Alias
    UMLS CUI [1]
    C2316983
    Stage at Diagnosis
    Description

    Stage at Diagnosis

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1300072
    UMLS CUI [1,2]
    C0011900
    Stage at Enrollment
    Description

    Stage at Enrollment

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1300072
    UMLS CUI [1,2]
    C1516879
    Lymphoma Cell Type
    Description

    Lymphoma Cell Type

    Alias
    UMLS CUI-1
    C0024299
    UMLS CUI-2
    C0449475
    Cell Type
    Description

    Cell Type

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0449475
    Timepoint
    Description

    Timepoint

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348792
    Specify other Cell-Type
    Description

    Specify other Cell-Type

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0449475
    UMLS CUI [1,2]
    C2348235
    Lymphoma Grade
    Description

    Lymphoma Grade

    Alias
    UMLS CUI-1
    C0024299
    UMLS CUI-2
    C0441800
    Lymphoma Grade
    Description

    Lymphoma Grade

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0024299
    UMLS CUI [1,2]
    C0441800
    Timepoint
    Description

    At diagnosis: only intermediate subtype of follicular large cell NHL

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348792
    History of Lymphoma - Extranodal Involvement
    Description

    History of Lymphoma - Extranodal Involvement

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0024299
    UMLS CUI [1,2]
    C0262926
    UMLS CUI [2]
    C3899187
    History of Lymphoma
    Description

    History of Lymphoma

    Alias
    UMLS CUI-1
    C0024299
    UMLS CUI-2
    C0262926
    History of Lymphoma - Extranodal Involvement at Enrollment
    Description

    History of Lymphoma - Extranodal Involvement at Enrollment

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0024299
    UMLS CUI [1,2]
    C0262926
    UMLS CUI [2]
    C3899187
    CD20 Reactivity
    Description

    Please check one method

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0054946
    Date tissue obtainted (CD20 Reactivity)
    Description

    Date tissue obtainted (CD20 Reactivity)

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0475358
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [2]
    C0054946
    Date of assay (CD20 Reactivity)
    Description

    Date of assay (CD20 Reactivity)

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0005507
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [2]
    C0054946
    Does patient have evidence of bulky disease (> 500 gm)?
    Description

    Does patient have evidence of bulky disease (> 500 gm)?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1511341
    UMLS CUI [1,2]
    C0332120
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    Similar models

    Patient Enrollment/ Patient Eligibility - Demographics; General Medical History; Prior Therapy; History of Lymphoma

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Site Number
    Item
    Site Number
    integer
    C2825164 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Patient Number
    Item
    Patient Number
    text
    C0030705 (UMLS CUI [1,1])
    C1300638 (UMLS CUI [1,2])
    Patient Initials
    Item
    Patient Initials
    text
    C2986440 (UMLS CUI [1])
    Item Group
    Demographics (Enrollment)
    C1704791 (UMLS CUI-1)
    C1516879 (UMLS CUI-2)
    Patient Body Weight
    Item
    Patient Body Weight
    float
    C0005910 (UMLS CUI [1])
    Patient Height
    Item
    Patient Height
    integer
    C0005890 (UMLS CUI [1])
    Date of birth
    Item
    Date of birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Gender
    integer
    C0079399 (UMLS CUI [1])
    Gender
    Code List
    Gender
    CL Item
    M (1)
    CL Item
    F (2)
    Item Group
    Investigator Signature
    C2346576 (UMLS CUI-1)
    Investigator Signature
    Item
    Investigator Signature
    text
    C2346576 (UMLS CUI [1])
    Investigator Signature Date
    Item
    Investigator Signature Date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    For Coulter Use Only
    C3846158 (UMLS CUI-1)
    Patient Enrollment Authorized by
    Item
    Patient Enrollment Authorized by
    text
    C1555472 (UMLS CUI [1,1])
    C2700391 (UMLS CUI [1,2])
    C4041024 (UMLS CUI [1,3])
    Enrollment Date
    Item
    Enrollment Date
    date
    C0011008 (UMLS CUI [1,1])
    C0679646 (UMLS CUI [1,2])
    C1516879 (UMLS CUI [1,3])
    Item
    Approved Dose
    integer
    C0178602 (UMLS CUI [1,1])
    C0205540 (UMLS CUI [1,2])
    Approved Dose
    Code List
    Approved Dose
    CL Item
    45 cGy (1)
    CL Item
    55 cGy (2)
    CL Item
    65 cGy (3)
    CL Item
    75 cGy (4)
    CL Item
    Other (5)
    Other approved dose
    Item
    Other approved dose
    text
    C0178602 (UMLS CUI [1,1])
    C0205540 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    Adjust mCi dose for obesity
    Item
    Adjust mCi dose for obesity
    boolean
    C1707811 (UMLS CUI [1,1])
    C0028754 (UMLS CUI [1,2])
    Item Group
    Demographics (General Medical History)
    C1704791 (UMLS CUI-1)
    C0262926 (UMLS CUI-2)
    Date of Birth
    Item
    Date of Birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Gender
    integer
    C0079399 (UMLS CUI [1])
    Gender
    Code List
    Gender
    CL Item
    M (1)
    CL Item
    F (2)
    Item
    Ethnic Origin
    integer
    C0015031 (UMLS CUI [1])
    Ethnic Origin
    Code List
    Ethnic Origin
    CL Item
    White (1)
    CL Item
    Hispanic (2)
    CL Item
    Asian (3)
    CL Item
    Black (4)
    CL Item
    Native American (5)
    CL Item
    Othe (6)
    Other Ethnic Origin
    Item
    Other Ethnic Origin
    text
    C0015031 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Item Group
    Medical History Date
    C0262926 (UMLS CUI-1)
    C0011008 (UMLS CUI-2)
    Medical History Date
    Item
    Medical History Date
    date
    C0262926 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    General Medical History
    C0262926 (UMLS CUI-1)
    Diagnosis/Condition
    Item
    Diagnosis/Condition
    text
    C0011900 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    Date of Disease Onset
    Item
    Date of Disease Onset
    partialDate
    C0012634 (UMLS CUI [1,1])
    C0574845 (UMLS CUI [1,2])
    Item
    Disease Status
    integer
    C0012634 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    Disease Status
    Code List
    Disease Status
    CL Item
    Active (1)
    CL Item
    Inactive (2)
    Item Group
    Prior Therapy
    C1514463 (UMLS CUI-1)
    Drugs
    Item
    Drugs
    text
    C0013227 (UMLS CUI [1])
    Therapy Start Date
    Item
    Therapy Start Date
    date
    C3173309 (UMLS CUI [1])
    Therapy Stop Date
    Item
    Therapy Stop Date
    date
    C1531784 (UMLS CUI [1])
    Number of Therapy Cycles
    Item
    Number of Therapy Cycles
    integer
    C0178602 (UMLS CUI [1,1])
    C0750480 (UMLS CUI [1,2])
    Item
    Therapeutic Outcome
    integer
    C0087111 (UMLS CUI [1,1])
    C1547647 (UMLS CUI [1,2])
    Therapeutic Outcome
    Code List
    Therapeutic Outcome
    CL Item
    CR (1)
    CL Item
    CCR (2)
    CL Item
    PR (3)
    CL Item
    SD (4)
    CL Item
    PD (5)
    CL Item
    Unknown (6)
    Duration of Response
    Item
    Duration of Response
    integer
    C0237585 (UMLS CUI [1])
    Item Group
    Prior Radiation Therapy
    C0279134 (UMLS CUI-1)
    Radiation Therapy Start Date
    Item
    Radiation Therapy Start Date
    date
    C1522449 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Radiation Therapy Stop Date
    Item
    Radiation Therapy Stop Date
    date
    C1522449 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Radiation Therapy Total Dose
    Item
    Radiation Therapy Total Dose
    integer
    C2919490 (UMLS CUI [1])
    Radiation Therapy Location
    Item
    Radiation Therapy Location
    text
    C1522449 (UMLS CUI [1,1])
    C0450429 (UMLS CUI [1,2])
    Item Group
    History of Lymphoma
    C0024299 (UMLS CUI-1)
    C0262926 (UMLS CUI-2)
    Date of Diagnosis
    Item
    Date of Diagnosis
    date
    C2316983 (UMLS CUI [1])
    Item
    Stage at Diagnosis
    integer
    C1300072 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    Stage at Diagnosis
    Code List
    Stage at Diagnosis
    CL Item
    I (1)
    CL Item
    II (2)
    CL Item
    III (3)
    CL Item
    IV (4)
    Item
    Stage at Enrollment
    integer
    C1300072 (UMLS CUI [1,1])
    C1516879 (UMLS CUI [1,2])
    Stage at Enrollment
    Code List
    Stage at Enrollment
    CL Item
    IV (1)
    Item Group
    Lymphoma Cell Type
    C0024299 (UMLS CUI-1)
    C0449475 (UMLS CUI-2)
    Item
    Cell Type
    integer
    C0449475 (UMLS CUI [1])
    Cell Type
    Code List
    Cell Type
    CL Item
    Small lymphocytic with plasmacytoid differentiation (1)
    CL Item
    Small lymphocytic without plasmacytoid differentiation (2)
    CL Item
    Follicular, small-cleaved cell (3)
    CL Item
    Follicular, mixed small-cleaved cell (< 50% large cell) (4)
    CL Item
    Follicular, large cell (5)
    CL Item
    Diffuse, small-cleaved (6)
    CL Item
    Diffuse, mixed small-cleaved & large cell (7)
    CL Item
    Diffuse, large cell (8)
    CL Item
    Large cell, immunoblastic (9)
    CL Item
    Lymphoblastic, convoluted (10)
    CL Item
    Lymphoblastic, non-convoluted (11)
    CL Item
    Monocytoid B-cell (12)
    CL Item
    Other (specify) (13)
    Item
    Timepoint
    integer
    C2348792 (UMLS CUI [1])
    Timepoint
    Code List
    Timepoint
    CL Item
    At Diagnosis (1)
    CL Item
    At Enrollment (2)
    Specify other Cell-Type
    Item
    Specify other Cell-Type
    text
    C0449475 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Item Group
    Lymphoma Grade
    C0024299 (UMLS CUI-1)
    C0441800 (UMLS CUI-2)
    Item
    Lymphoma Grade
    integer
    C0024299 (UMLS CUI [1,1])
    C0441800 (UMLS CUI [1,2])
    Lymphoma Grade
    Code List
    Lymphoma Grade
    CL Item
    Low (1)
    CL Item
    Intermediate (2)
    CL Item
    High (3)
    Item
    Timepoint
    integer
    C2348792 (UMLS CUI [1])
    Timepoint
    Code List
    Timepoint
    CL Item
    At Diagnosis (1)
    CL Item
    At Enrollment (2)
    History of Lymphoma - Extranodal Involvement
    Item
    History of Lymphoma - Extranodal Involvement
    text
    C0024299 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    C3899187 (UMLS CUI [2])
    Item Group
    History of Lymphoma
    C0024299 (UMLS CUI-1)
    C0262926 (UMLS CUI-2)
    Item
    History of Lymphoma - Extranodal Involvement at Enrollment
    integer
    C0024299 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    C3899187 (UMLS CUI [2])
    History of Lymphoma - Extranodal Involvement at Enrollment
    Code List
    History of Lymphoma - Extranodal Involvement at Enrollment
    CL Item
    0 (1)
    CL Item
    1 (2)
    CL Item
    2 or more sites (3)
    Item
    CD20 Reactivity
    integer
    C0054946 (UMLS CUI [1])
    CD20 Reactivity
    Code List
    CD20 Reactivity
    CL Item
    Histopathology (1)
    CL Item
    Flow Cytometry (2)
    Date tissue obtainted (CD20 Reactivity)
    Item
    Date tissue obtainted (CD20 Reactivity)
    date
    C0475358 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0054946 (UMLS CUI [2])
    Date of assay (CD20 Reactivity)
    Item
    Date of assay (CD20 Reactivity)
    date
    C0005507 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0054946 (UMLS CUI [2])
    Does patient have evidence of bulky disease (> 500 gm)?
    Item
    Does patient have evidence of bulky disease (> 500 gm)?
    boolean
    C1511341 (UMLS CUI [1,1])
    C0332120 (UMLS CUI [1,2])
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