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ID

39094

Description

Safety and Efficacy Study of Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01325701

Link

https://clinicaltrials.gov/show/NCT01325701

Keywords

Versions (1)
  1. 12/1/19 12/1/19 -
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December 1, 2019

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    Eligibility Diffuse Large Cell B-lymphoma NCT01325701

    English

    Eligibility Diffuse Large Cell B-lymphoma NCT01325701

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. men and women ≥ 18 years of age.
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    2. ecog performance status ≤ 2.
    Description

    ECOG performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    3. pathologically confirmed de novo dlbcl
    Description

    Diffuse Large B-Cell Lymphoma de novo

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0079744
    UMLS CUI [1,2]
    C1515568
    4. subjects must have available tissue for central pathology review to be eligible. treatment group 2: subjects will be eligible if they have the non-gcb phenotype, as confirmed by central ihc testing by the hans method.
    Description

    Availability of Tissue | Phenotype Except Germinal Center B-Cell Type | Immunohistochemistry

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0470187
    UMLS CUI [1,2]
    C0040300
    UMLS CUI [2,1]
    C0031437
    UMLS CUI [2,2]
    C0332300
    UMLS CUI [2,3]
    C1333295
    UMLS CUI [3]
    C0021044
    5. relapsed or refractory disease, defined as either: 1) recurrence of disease after a cr, or 2) pr, sd, or progressive disease (pd) at completion of the treatment regimen preceding entry to the study (residual disease): subjects must have previously received an appropriate first-line treatment regimen. subjects who have not received hdt/asct must be ineligible for hdt/asct
    Description

    Recurrent disease | Refractory Disease | Recurrence Post Complete remission | Partial response | Stable Disease | Progressive Disease | Treatment regimen Completion | Residual disease | Status post First line treatment | High-Dose Chemotherapy with Autologous Stem Cell Transplant

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0277556
    UMLS CUI [2]
    C1514815
    UMLS CUI [3,1]
    C0034897
    UMLS CUI [3,2]
    C0687676
    UMLS CUI [3,3]
    C0677874
    UMLS CUI [4]
    C1521726
    UMLS CUI [5]
    C0677946
    UMLS CUI [6]
    C1335499
    UMLS CUI [7,1]
    C0040808
    UMLS CUI [7,2]
    C0205197
    UMLS CUI [8]
    C0543478
    UMLS CUI [9,1]
    C0231290
    UMLS CUI [9,2]
    C1708063
    UMLS CUI [10]
    C1512429
    6. treatment group 1: subjects must have ≥ 1 measurable (> 2 cm in longest dimension) disease sites on ct scan. treatment group 2: subjects must have ≥ 1 measurable (> 1.5 cm in longest dimension) disease sites on ct scan.
    Description

    Measurable Disease Site Quantity CT scan | Measurable Disease Longest Diameter

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1513041
    UMLS CUI [1,2]
    C1515974
    UMLS CUI [1,3]
    C1265611
    UMLS CUI [1,4]
    C0040405
    UMLS CUI [2,1]
    C1513041
    UMLS CUI [2,2]
    C0552406
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. transformed dlbcl or dlbcl with coexistent histologies (eg, fl or malt).
    Description

    Diffuse Large B-Cell Lymphoma Transformed | Diffuse Large B-Cell Lymphoma with Follicular Lymphoma | Diffuse Large B-Cell Lymphoma with MALT Lymphoma

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0079744
    UMLS CUI [1,2]
    C0457344
    UMLS CUI [2,1]
    C0079744
    UMLS CUI [2,2]
    C0332287
    UMLS CUI [2,3]
    C0024301
    UMLS CUI [3,1]
    C0079744
    UMLS CUI [3,2]
    C0332287
    UMLS CUI [3,3]
    C0242647
    2. primary mediastinal (thymic) large b-cell lymphoma.
    Description

    Mediastinal (Thymic) Large B-Cell Lymphoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1292754
    3. known central nervous system lymphoma. in addition, for subjects in treatment group 2, known leptomeningeal involvement is exclusionary.
    Description

    Primary central nervous system lymphoma | Involvement Leptomeningeal

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0280803
    UMLS CUI [2,1]
    C1314939
    UMLS CUI [2,2]
    C0521401
    4. certain exclusions on prior therapy
    Description

    Exclusion Due to Prior Therapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2828389
    UMLS CUI [1,2]
    C0678226
    UMLS CUI [1,3]
    C1514463
    5. major surgery within 2 weeks of first dose of study drug.
    Description

    Major surgery

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0679637
    6. any of the following laboratory abnormalities:
    Description

    LABORATORY ABNORMALITIES

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1853129
    1. anc < 0.75 x 10^9/l. treatment group 2: eligible subjects must be independent of growth factor support for 7 days prior to the screening lab tests.
    Description

    Absolute neutrophil count | Eligibility Independent of Growth Factor Support

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0948762
    UMLS CUI [2,1]
    C1548635
    UMLS CUI [2,2]
    C0332291
    UMLS CUI [2,3]
    C0018284
    UMLS CUI [2,4]
    C1521721
    2. platelet count < 50 x 10^9/l independent of transfusion support. treatment group 2 only: eligible subjects must be independent of transfusion support for 7 days prior to the screening lab tests.
    Description

    Platelet Count measurement | Independent of Transfusion Support | Eligibility Independent of Transfusion Support

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032181
    UMLS CUI [2,1]
    C0332291
    UMLS CUI [2,2]
    C1879316
    UMLS CUI [2,3]
    C1521721
    UMLS CUI [3,1]
    C1548635
    UMLS CUI [3,2]
    C0332291
    UMLS CUI [3,3]
    C1879316
    UMLS CUI [3,4]
    C1521721
    3. ast or alt ≥ 3.0 x upper limit of normal (uln)
    Description

    Aspartate aminotransferase increased | Alanine aminotransferase increased

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0151904
    UMLS CUI [2]
    C0151905
    4. creatinine > 2.0 x uln
    Description

    Serum creatinine raised

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0700225
    5. treatment group 2 only: hemoglobin < 8.0 g/dl
    Description

    Hemoglobin measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0518015
    6. treatment group 2 only: total bilirubin > 1.5 x uln
    Description

    Elevated total bilirubin

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0741494
    7. requires or has received anticoagulation treatment with warfarin or equivalent vitamin k antagonists (eg, phenprocoumon)
    Description

    Requirement Anticoagulation Therapy | Anticoagulation Therapy | Warfarin therapy | Treatment with Vitamin K antagonist | Phenprocoumon

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1514873
    UMLS CUI [1,2]
    C0003281
    UMLS CUI [2]
    C0003281
    UMLS CUI [3]
    C4303340
    UMLS CUI [4]
    C1096489
    UMLS CUI [5]
    C0031444
    8. treatment group 2: requires treatment with a strong cytochrome p450 (cyp) 3a4/5 inhibitor
    Description

    Requirement CYP3A4 Inhibitor Strong | Requirement CYP3A5 Inhibitors Strong

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1514873
    UMLS CUI [1,2]
    C3830624
    UMLS CUI [1,3]
    C0442821
    UMLS CUI [2,1]
    C1514873
    UMLS CUI [2,2]
    C3850054
    UMLS CUI [2,3]
    C0442821
    9. treatment group 2: known bleeding diathesis, eg, von willebrand's disease, hemophilia.
    Description

    Bleeding tendency | von Willebrand Disease | Hemophilia

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1458140
    UMLS CUI [2]
    C0042974
    UMLS CUI [3]
    C0684275
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    Similar models

    Eligibility Diffuse Large Cell B-lymphoma NCT01325701

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    1. men and women ≥ 18 years of age.
    boolean
    C0001779 (UMLS CUI [1])
    ECOG performance status
    Item
    2. ecog performance status ≤ 2.
    boolean
    C1520224 (UMLS CUI [1])
    Diffuse Large B-Cell Lymphoma de novo
    Item
    3. pathologically confirmed de novo dlbcl
    boolean
    C0079744 (UMLS CUI [1,1])
    C1515568 (UMLS CUI [1,2])
    Availability of Tissue | Phenotype Except Germinal Center B-Cell Type | Immunohistochemistry
    Item
    4. subjects must have available tissue for central pathology review to be eligible. treatment group 2: subjects will be eligible if they have the non-gcb phenotype, as confirmed by central ihc testing by the hans method.
    boolean
    C0470187 (UMLS CUI [1,1])
    C0040300 (UMLS CUI [1,2])
    C0031437 (UMLS CUI [2,1])
    C0332300 (UMLS CUI [2,2])
    C1333295 (UMLS CUI [2,3])
    C0021044 (UMLS CUI [3])
    Recurrent disease | Refractory Disease | Recurrence Post Complete remission | Partial response | Stable Disease | Progressive Disease | Treatment regimen Completion | Residual disease | Status post First line treatment | High-Dose Chemotherapy with Autologous Stem Cell Transplant
    Item
    5. relapsed or refractory disease, defined as either: 1) recurrence of disease after a cr, or 2) pr, sd, or progressive disease (pd) at completion of the treatment regimen preceding entry to the study (residual disease): subjects must have previously received an appropriate first-line treatment regimen. subjects who have not received hdt/asct must be ineligible for hdt/asct
    boolean
    C0277556 (UMLS CUI [1])
    C1514815 (UMLS CUI [2])
    C0034897 (UMLS CUI [3,1])
    C0687676 (UMLS CUI [3,2])
    C0677874 (UMLS CUI [3,3])
    C1521726 (UMLS CUI [4])
    C0677946 (UMLS CUI [5])
    C1335499 (UMLS CUI [6])
    C0040808 (UMLS CUI [7,1])
    C0205197 (UMLS CUI [7,2])
    C0543478 (UMLS CUI [8])
    C0231290 (UMLS CUI [9,1])
    C1708063 (UMLS CUI [9,2])
    C1512429 (UMLS CUI [10])
    Measurable Disease Site Quantity CT scan | Measurable Disease Longest Diameter
    Item
    6. treatment group 1: subjects must have ≥ 1 measurable (> 2 cm in longest dimension) disease sites on ct scan. treatment group 2: subjects must have ≥ 1 measurable (> 1.5 cm in longest dimension) disease sites on ct scan.
    boolean
    C1513041 (UMLS CUI [1,1])
    C1515974 (UMLS CUI [1,2])
    C1265611 (UMLS CUI [1,3])
    C0040405 (UMLS CUI [1,4])
    C1513041 (UMLS CUI [2,1])
    C0552406 (UMLS CUI [2,2])
    Item Group
    C0680251 (UMLS CUI)
    Diffuse Large B-Cell Lymphoma Transformed | Diffuse Large B-Cell Lymphoma with Follicular Lymphoma | Diffuse Large B-Cell Lymphoma with MALT Lymphoma
    Item
    1. transformed dlbcl or dlbcl with coexistent histologies (eg, fl or malt).
    boolean
    C0079744 (UMLS CUI [1,1])
    C0457344 (UMLS CUI [1,2])
    C0079744 (UMLS CUI [2,1])
    C0332287 (UMLS CUI [2,2])
    C0024301 (UMLS CUI [2,3])
    C0079744 (UMLS CUI [3,1])
    C0332287 (UMLS CUI [3,2])
    C0242647 (UMLS CUI [3,3])
    Mediastinal (Thymic) Large B-Cell Lymphoma
    Item
    2. primary mediastinal (thymic) large b-cell lymphoma.
    boolean
    C1292754 (UMLS CUI [1])
    Primary central nervous system lymphoma | Involvement Leptomeningeal
    Item
    3. known central nervous system lymphoma. in addition, for subjects in treatment group 2, known leptomeningeal involvement is exclusionary.
    boolean
    C0280803 (UMLS CUI [1])
    C1314939 (UMLS CUI [2,1])
    C0521401 (UMLS CUI [2,2])
    Exclusion Due to Prior Therapy
    Item
    4. certain exclusions on prior therapy
    boolean
    C2828389 (UMLS CUI [1,1])
    C0678226 (UMLS CUI [1,2])
    C1514463 (UMLS CUI [1,3])
    Major surgery
    Item
    5. major surgery within 2 weeks of first dose of study drug.
    boolean
    C0679637 (UMLS CUI [1])
    LABORATORY ABNORMALITIES
    Item
    6. any of the following laboratory abnormalities:
    boolean
    C1853129 (UMLS CUI [1])
    Absolute neutrophil count | Eligibility Independent of Growth Factor Support
    Item
    1. anc < 0.75 x 10^9/l. treatment group 2: eligible subjects must be independent of growth factor support for 7 days prior to the screening lab tests.
    boolean
    C0948762 (UMLS CUI [1])
    C1548635 (UMLS CUI [2,1])
    C0332291 (UMLS CUI [2,2])
    C0018284 (UMLS CUI [2,3])
    C1521721 (UMLS CUI [2,4])
    Platelet Count measurement | Independent of Transfusion Support | Eligibility Independent of Transfusion Support
    Item
    2. platelet count < 50 x 10^9/l independent of transfusion support. treatment group 2 only: eligible subjects must be independent of transfusion support for 7 days prior to the screening lab tests.
    boolean
    C0032181 (UMLS CUI [1])
    C0332291 (UMLS CUI [2,1])
    C1879316 (UMLS CUI [2,2])
    C1521721 (UMLS CUI [2,3])
    C1548635 (UMLS CUI [3,1])
    C0332291 (UMLS CUI [3,2])
    C1879316 (UMLS CUI [3,3])
    C1521721 (UMLS CUI [3,4])
    Aspartate aminotransferase increased | Alanine aminotransferase increased
    Item
    3. ast or alt ≥ 3.0 x upper limit of normal (uln)
    boolean
    C0151904 (UMLS CUI [1])
    C0151905 (UMLS CUI [2])
    Serum creatinine raised
    Item
    4. creatinine > 2.0 x uln
    boolean
    C0700225 (UMLS CUI [1])
    Hemoglobin measurement
    Item
    5. treatment group 2 only: hemoglobin < 8.0 g/dl
    boolean
    C0518015 (UMLS CUI [1])
    Elevated total bilirubin
    Item
    6. treatment group 2 only: total bilirubin > 1.5 x uln
    boolean
    C0741494 (UMLS CUI [1])
    Requirement Anticoagulation Therapy | Anticoagulation Therapy | Warfarin therapy | Treatment with Vitamin K antagonist | Phenprocoumon
    Item
    7. requires or has received anticoagulation treatment with warfarin or equivalent vitamin k antagonists (eg, phenprocoumon)
    boolean
    C1514873 (UMLS CUI [1,1])
    C0003281 (UMLS CUI [1,2])
    C0003281 (UMLS CUI [2])
    C4303340 (UMLS CUI [3])
    C1096489 (UMLS CUI [4])
    C0031444 (UMLS CUI [5])
    Requirement CYP3A4 Inhibitor Strong | Requirement CYP3A5 Inhibitors Strong
    Item
    8. treatment group 2: requires treatment with a strong cytochrome p450 (cyp) 3a4/5 inhibitor
    boolean
    C1514873 (UMLS CUI [1,1])
    C3830624 (UMLS CUI [1,2])
    C0442821 (UMLS CUI [1,3])
    C1514873 (UMLS CUI [2,1])
    C3850054 (UMLS CUI [2,2])
    C0442821 (UMLS CUI [2,3])
    Bleeding tendency | von Willebrand Disease | Hemophilia
    Item
    9. treatment group 2: known bleeding diathesis, eg, von willebrand's disease, hemophilia.
    boolean
    C1458140 (UMLS CUI [1])
    C0042974 (UMLS CUI [2])
    C0684275 (UMLS CUI [3])
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