0 Ratings
ID

29382

Description

Ofatumumab in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00742144

Link

https://clinicaltrials.gov/show/NCT00742144

Keywords

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

See clinicaltrials.gov

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March 21, 2018

DOI

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License

Creative Commons BY 4.0
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    Eligibility Follicular Lymphoma NCT00742144

    English

    Eligibility Follicular Lymphoma NCT00742144

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    signed informed consent.
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    histologically confirmed relapsed or refractory cd20 positive fl grade 1-3a and 1 or more clearly demarcated lesions with a largest diameter = 1.5 cm, or cd5, cd19, cd20 and cd23 positive relapse or refractory cll.
    Description

    Recurrent Follicular Lymphoma CD20 Positive Grade | Refractory Follicular Lymphoma CD20 Positive Grade | Sharply demarcated lesion Quantity Diameter Size | Recurrent Chronic Lymphoid Leukemia CD5 Positive | Chronic lymphocytic leukaemia refractory CD5 Positive | Recurrent Chronic Lymphoid Leukemia CD19 Positive | Chronic lymphocytic leukaemia refractory CD19 Positive | Recurrent Chronic Lymphoid Leukemia CD20 Positive | Chronic lymphocytic leukaemia refractory CD20 Positive | Recurrent Chronic Lymphoid Leukemia CD23 Positive | Chronic lymphocytic leukaemia refractory CD23 Positive

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1335701
    UMLS CUI [1,2]
    C0054946
    UMLS CUI [1,3]
    C1514241
    UMLS CUI [1,4]
    C0441800
    UMLS CUI [2,1]
    C1335723
    UMLS CUI [2,2]
    C0054946
    UMLS CUI [2,3]
    C1514241
    UMLS CUI [2,4]
    C0441800
    UMLS CUI [3,1]
    C2168704
    UMLS CUI [3,2]
    C1265611
    UMLS CUI [3,3]
    C1301886
    UMLS CUI [3,4]
    C0456389
    UMLS CUI [4,1]
    C0854802
    UMLS CUI [4,2]
    C0054964
    UMLS CUI [4,3]
    C1514241
    UMLS CUI [5,1]
    C0278791
    UMLS CUI [5,2]
    C0054964
    UMLS CUI [5,3]
    C1514241
    UMLS CUI [6,1]
    C0854802
    UMLS CUI [6,2]
    C0108748
    UMLS CUI [6,3]
    C1514241
    UMLS CUI [7,1]
    C0278791
    UMLS CUI [7,2]
    C0108748
    UMLS CUI [7,3]
    C1514241
    UMLS CUI [8,1]
    C0854802
    UMLS CUI [8,2]
    C0054946
    UMLS CUI [8,3]
    C1514241
    UMLS CUI [9,1]
    C0278791
    UMLS CUI [9,2]
    C0054946
    UMLS CUI [9,3]
    C1514241
    UMLS CUI [10,1]
    C0854802
    UMLS CUI [10,2]
    C0123242
    UMLS CUI [10,3]
    C1514241
    UMLS CUI [11,1]
    C0278791
    UMLS CUI [11,2]
    C0123242
    UMLS CUI [11,3]
    C1514241
    subjects must have adequate blood, liver, and kidney function.
    Description

    Hematologic function | Liver function | Renal function

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0221130
    UMLS CUI [2]
    C0232741
    UMLS CUI [3]
    C0232804
    subjects who passed the provided periods from the last anti-cancer treatments at screening
    Description

    Cancer treatment

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0920425
    ecog performance status of 0-2
    Description

    ECOG performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    life expectancy more than 24 weeks at screening
    Description

    Life Expectancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    current and past malignancy other than fl and cll within 5 years prior to screening.
    Description

    Malignant Neoplasms | Exception Follicular Lymphoma | Exception CLL

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0024301
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0023434
    known richter's transformation
    Description

    Richter's syndrome

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0349631
    previous autologous stem cell transplantation within 24 weeks prior to screening
    Description

    Transplantation of autologous hematopoietic stem cell

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1831743
    previous allogeneic stem cell transplantation
    Description

    Allogeneic Stem Cell Transplantation

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2242529
    known cns involvement
    Description

    Central Nervous System Involvement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C4050309
    history of significant cerebrovascular disease
    Description

    Cerebrovascular Disorders

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0007820
    current cardiac disease requiring medical treatment
    Description

    Heart Disease Treatment required for

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0018799
    UMLS CUI [1,2]
    C0332121
    chronic or ongoing active infectious disease requiring systemic treatment
    Description

    Chronic infectious disease Requirement Systemic therapy | Communicable Disease Requirement Systemic therapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0151317
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C1515119
    UMLS CUI [2,1]
    C0009450
    UMLS CUI [2,2]
    C1514873
    UMLS CUI [2,3]
    C1515119
    patients with pleural effusion or ascites detectable by physical examination
    Description

    Pleural effusion Physical Examination | Ascites Physical Examination

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0032227
    UMLS CUI [1,2]
    C0031809
    UMLS CUI [2,1]
    C0003962
    UMLS CUI [2,2]
    C0031809
    positive serology test for any of hbsag, anti-hbc or anti-hcv
    Description

    Serology positive Hepatitis B Surface Antigens | Serology positive Anti-HBc | Serology positive Anti-HCV

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0242089
    UMLS CUI [1,2]
    C0019168
    UMLS CUI [2,1]
    C0242089
    UMLS CUI [2,2]
    C0312631
    UMLS CUI [3,1]
    C0242089
    UMLS CUI [3,2]
    C0166049
    known hiv positive
    Description

    HIV Seropositivity

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019699
    pregnant or lactating women
    Description

    Pregnancy | Breast Feeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    women of childbearing potential and male patients not willing to use adequate contraception
    Description

    Childbearing Potential Contraceptive methods Unwilling | Gender Contraceptive methods Unwilling

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0700589
    UMLS CUI [1,3]
    C0558080
    UMLS CUI [2,1]
    C0079399
    UMLS CUI [2,2]
    C0700589
    UMLS CUI [2,3]
    C0558080
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    Similar models

    Eligibility Follicular Lymphoma NCT00742144

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Informed Consent
    Item
    signed informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    Recurrent Follicular Lymphoma CD20 Positive Grade | Refractory Follicular Lymphoma CD20 Positive Grade | Sharply demarcated lesion Quantity Diameter Size | Recurrent Chronic Lymphoid Leukemia CD5 Positive | Chronic lymphocytic leukaemia refractory CD5 Positive | Recurrent Chronic Lymphoid Leukemia CD19 Positive | Chronic lymphocytic leukaemia refractory CD19 Positive | Recurrent Chronic Lymphoid Leukemia CD20 Positive | Chronic lymphocytic leukaemia refractory CD20 Positive | Recurrent Chronic Lymphoid Leukemia CD23 Positive | Chronic lymphocytic leukaemia refractory CD23 Positive
    Item
    histologically confirmed relapsed or refractory cd20 positive fl grade 1-3a and 1 or more clearly demarcated lesions with a largest diameter = 1.5 cm, or cd5, cd19, cd20 and cd23 positive relapse or refractory cll.
    boolean
    C1335701 (UMLS CUI [1,1])
    C0054946 (UMLS CUI [1,2])
    C1514241 (UMLS CUI [1,3])
    C0441800 (UMLS CUI [1,4])
    C1335723 (UMLS CUI [2,1])
    C0054946 (UMLS CUI [2,2])
    C1514241 (UMLS CUI [2,3])
    C0441800 (UMLS CUI [2,4])
    C2168704 (UMLS CUI [3,1])
    C1265611 (UMLS CUI [3,2])
    C1301886 (UMLS CUI [3,3])
    C0456389 (UMLS CUI [3,4])
    C0854802 (UMLS CUI [4,1])
    C0054964 (UMLS CUI [4,2])
    C1514241 (UMLS CUI [4,3])
    C0278791 (UMLS CUI [5,1])
    C0054964 (UMLS CUI [5,2])
    C1514241 (UMLS CUI [5,3])
    C0854802 (UMLS CUI [6,1])
    C0108748 (UMLS CUI [6,2])
    C1514241 (UMLS CUI [6,3])
    C0278791 (UMLS CUI [7,1])
    C0108748 (UMLS CUI [7,2])
    C1514241 (UMLS CUI [7,3])
    C0854802 (UMLS CUI [8,1])
    C0054946 (UMLS CUI [8,2])
    C1514241 (UMLS CUI [8,3])
    C0278791 (UMLS CUI [9,1])
    C0054946 (UMLS CUI [9,2])
    C1514241 (UMLS CUI [9,3])
    C0854802 (UMLS CUI [10,1])
    C0123242 (UMLS CUI [10,2])
    C1514241 (UMLS CUI [10,3])
    C0278791 (UMLS CUI [11,1])
    C0123242 (UMLS CUI [11,2])
    C1514241 (UMLS CUI [11,3])
    Hematologic function | Liver function | Renal function
    Item
    subjects must have adequate blood, liver, and kidney function.
    boolean
    C0221130 (UMLS CUI [1])
    C0232741 (UMLS CUI [2])
    C0232804 (UMLS CUI [3])
    Cancer treatment
    Item
    subjects who passed the provided periods from the last anti-cancer treatments at screening
    boolean
    C0920425 (UMLS CUI [1])
    ECOG performance status
    Item
    ecog performance status of 0-2
    boolean
    C1520224 (UMLS CUI [1])
    Life Expectancy
    Item
    life expectancy more than 24 weeks at screening
    boolean
    C0023671 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Malignant Neoplasms | Exception Follicular Lymphoma | Exception CLL
    Item
    current and past malignancy other than fl and cll within 5 years prior to screening.
    boolean
    C0006826 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0024301 (UMLS CUI [2,2])
    C1705847 (UMLS CUI [3,1])
    C0023434 (UMLS CUI [3,2])
    Richter's syndrome
    Item
    known richter's transformation
    boolean
    C0349631 (UMLS CUI [1])
    Transplantation of autologous hematopoietic stem cell
    Item
    previous autologous stem cell transplantation within 24 weeks prior to screening
    boolean
    C1831743 (UMLS CUI [1])
    Allogeneic Stem Cell Transplantation
    Item
    previous allogeneic stem cell transplantation
    boolean
    C2242529 (UMLS CUI [1])
    Central Nervous System Involvement
    Item
    known cns involvement
    boolean
    C4050309 (UMLS CUI [1])
    Cerebrovascular Disorders
    Item
    history of significant cerebrovascular disease
    boolean
    C0007820 (UMLS CUI [1])
    Heart Disease Treatment required for
    Item
    current cardiac disease requiring medical treatment
    boolean
    C0018799 (UMLS CUI [1,1])
    C0332121 (UMLS CUI [1,2])
    Chronic infectious disease Requirement Systemic therapy | Communicable Disease Requirement Systemic therapy
    Item
    chronic or ongoing active infectious disease requiring systemic treatment
    boolean
    C0151317 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C1515119 (UMLS CUI [1,3])
    C0009450 (UMLS CUI [2,1])
    C1514873 (UMLS CUI [2,2])
    C1515119 (UMLS CUI [2,3])
    Pleural effusion Physical Examination | Ascites Physical Examination
    Item
    patients with pleural effusion or ascites detectable by physical examination
    boolean
    C0032227 (UMLS CUI [1,1])
    C0031809 (UMLS CUI [1,2])
    C0003962 (UMLS CUI [2,1])
    C0031809 (UMLS CUI [2,2])
    Serology positive Hepatitis B Surface Antigens | Serology positive Anti-HBc | Serology positive Anti-HCV
    Item
    positive serology test for any of hbsag, anti-hbc or anti-hcv
    boolean
    C0242089 (UMLS CUI [1,1])
    C0019168 (UMLS CUI [1,2])
    C0242089 (UMLS CUI [2,1])
    C0312631 (UMLS CUI [2,2])
    C0242089 (UMLS CUI [3,1])
    C0166049 (UMLS CUI [3,2])
    HIV Seropositivity
    Item
    known hiv positive
    boolean
    C0019699 (UMLS CUI [1])
    Pregnancy | Breast Feeding
    Item
    pregnant or lactating women
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Childbearing Potential Contraceptive methods Unwilling | Gender Contraceptive methods Unwilling
    Item
    women of childbearing potential and male patients not willing to use adequate contraception
    boolean
    C3831118 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    C0558080 (UMLS CUI [1,3])
    C0079399 (UMLS CUI [2,1])
    C0700589 (UMLS CUI [2,2])
    C0558080 (UMLS CUI [2,3])
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