ID

39092

Descripción

Study of Ofatumomab in Combination With ICE-chemotherapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL); ODM derived from: https://clinicaltrials.gov/show/NCT02412267

Link

https://clinicaltrials.gov/show/NCT02412267

Palabras clave

Versiones (2)
  1. 30/11/19 30/11/19 -
  2. 1/12/19 1/12/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

1 de diciembre de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
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    Eligibility Diffuse Large B-cell Lymphoma NCT02412267

    Inglés

    Eligibility Diffuse Large B-cell Lymphoma NCT02412267

    1 formularios  
    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. refractory or relapsed cd20 positive dlbcl following rituximab combined with chemotherapy.
    Descripción

    Diffuse large B-cell lymphoma refractory CD20 positive | Diffuse large B-cell lymphoma recurrent CD20 positive | Status post Combined Modality Therapy | rituximab | Chemotherapy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0855112
    UMLS CUI [1,2]
    C3888518
    UMLS CUI [2,1]
    C0855111
    UMLS CUI [2,2]
    C3888518
    UMLS CUI [3,1]
    C0231290
    UMLS CUI [3,2]
    C0009429
    UMLS CUI [4]
    C0393022
    UMLS CUI [5]
    C0392920
    2. participants must have measurable disease
    Descripción

    Measurable Disease

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1513041
    3. ecog performance status 0-2
    Descripción

    ECOG performance status

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    4. unless due to lymphomatous involvement, participants must have adequate organ and marrow function as defined below:
    Descripción

    Exception Involvement Lymphomatous | Organ function | Bone Marrow function

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1705847
    UMLS CUI [1,2]
    C1314939
    UMLS CUI [1,3]
    C0024299
    UMLS CUI [2]
    C0678852
    UMLS CUI [3,1]
    C0005953
    UMLS CUI [3,2]
    C0031843
    hemoglobin ≥ 10g/dl
    Descripción

    Hemoglobin measurement

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0518015
    absolute neutrophil count ≥ 1500/mm3
    Descripción

    Absolute neutrophil count

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0948762
    platelets ≥ 100 000/mm3
    Descripción

    Platelet Count measurement

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0032181
    alt and ast ≤ 3 x upper limit of normal (uln),
    Descripción

    Alanine aminotransferase measurement | Aspartate aminotransferase measurement

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0201836
    UMLS CUI [2]
    C0201899
    total serum bilirubin ≤ 1.5 x uln
    Descripción

    Serum total bilirubin measurement

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1278039
    serum creatinine ≤ 1.5 x uln
    Descripción

    Creatinine measurement, serum

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    5. fully recovered (≤ grade 1 or returned to baseline or deemed irreversible) from the acute effects of prior cancer therapy before initiation of study drug
    Descripción

    Effects of Cancer treatment | Patient recovered CTCAE Grades | Return to Baseline | Irreversible toxic effect Assessed

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1704420
    UMLS CUI [1,2]
    C0920425
    UMLS CUI [2,1]
    C1115804
    UMLS CUI [2,2]
    C1516728
    UMLS CUI [3,1]
    C0332156
    UMLS CUI [3,2]
    C1442488
    UMLS CUI [4,1]
    C0678774
    UMLS CUI [4,2]
    C1516048
    6. ability to understand and the willingness to sign a written informed consent document
    Descripción

    Informed Consent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. any previous cancer therapy for lymphoma, with the exception of rituximab in combination with chemotherapy (not more than 1 prior line of chemotherapy)
    Descripción

    Cancer treatment Lymphoma | Exception Combined Modality Therapy | rituximab | Chemotherapy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0920425
    UMLS CUI [1,2]
    C0024299
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0009429
    UMLS CUI [3]
    C0393022
    UMLS CUI [4]
    C0392920
    2. participants who have had systemic anti-cancer therapy within 3 weeks (8 weeks for nitrosoureas or mitomycin c) prior to study entry
    Descripción

    Cancer treatment Systemic | Nitrosoureas | Mitomycin

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0920425
    UMLS CUI [1,2]
    C0205373
    UMLS CUI [2]
    C0028210
    UMLS CUI [3]
    C0002475
    3. participants who have had radiotherapy and/ or major surgery within 3 weeks prior to study entry
    Descripción

    Therapeutic radiology procedure | Major surgery

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1522449
    UMLS CUI [2]
    C0679637
    4. participants who have had systemic corticosteroids for the purpose of treating lymphoma within 2 weeks prior to study entry are ineligible. patients receiving stable (not increased within the last month) chronic doses of systemic corticosteroids with a maximum dose of 20 mg of prednisolone (or equivalent) per day are eligible if they are being given for disorders other than lymphoma
    Descripción

    CORTICOSTEROIDS FOR SYSTEMIC USE Treating Lymphoma

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C3653708
    UMLS CUI [1,2]
    C1522326
    UMLS CUI [1,3]
    C0024299
    5. concurrent use of any other anti-cancer therapies or study agents.
    Descripción

    Cancer treatment | Investigational New Drugs

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0920425
    UMLS CUI [2]
    C0013230
    6. presence of symptomatic or uncontrolled brain or central nervous system lymphomatous lesions
    Descripción

    Primary cerebral lymphoma Symptomatic | Primary cerebral lymphoma Uncontrolled | Primary central nervous system lymphoma Symptomatic | Primary central nervous system lymphoma Uncontrolled

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0240803
    UMLS CUI [1,2]
    C0231220
    UMLS CUI [2,1]
    C0240803
    UMLS CUI [2,2]
    C0205318
    UMLS CUI [3,1]
    C0280803
    UMLS CUI [3,2]
    C0231220
    UMLS CUI [4,1]
    C0280803
    UMLS CUI [4,2]
    C0205318
    7. uncontrolled intercurrent illness including, but not limited to ongoing or active infection, clinically significant cardiac disease including a history of cardiac disease or congestive heart failure > nyha class 2, unstable angina (anginal symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months, significant cardiac arrhythmias and/ or requiring anti-arrhythmics; pulmonary disease; liver diseases such as cirrhosis, chronic active or persistent hepatitis; or acute/ chronic medical/ psychiatric illness/ social situations or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or limit compliance with study requirements, or interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
    Descripción

    Comorbidity Uncontrolled | Communicable Disease | Heart Disease | Medical History Heart Disease | Congestive heart failure New York Heart Association Classification | Angina, Unstable | New onset angina | Myocardial Infarction | Cardiac Arrhythmia | Requirement Anti-Arrhythmia Agents | Lung disease | Liver disease | Liver Cirrhosis | Hepatitis, Chronic | Chronic Persistent Hepatitis | Disease Study Subject Participation Status At risk | Disease Investigational New Drugs At risk | Disease Limiting Protocol Compliance | Disease Interferes with Interpretation Research results | Disease Study Subject Participation Status Inappropriate | Chronic disease Study Subject Participation Status At risk | Mental disorders Study Subject Participation Status At risk | Chronic mental disorder Study Subject Participation Status At risk | Social situation Study Subject Participation Status At risk | LABORATORY ABNORMALITIES Study Subject Participation Status At risk

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0205318
    UMLS CUI [2]
    C0009450
    UMLS CUI [3]
    C0018799
    UMLS CUI [4,1]
    C0262926
    UMLS CUI [4,2]
    C0018799
    UMLS CUI [5,1]
    C0018802
    UMLS CUI [5,2]
    C1275491
    UMLS CUI [6]
    C0002965
    UMLS CUI [7]
    C0340289
    UMLS CUI [8]
    C0027051
    UMLS CUI [9]
    C0003811
    UMLS CUI [10,1]
    C1514873
    UMLS CUI [10,2]
    C0003195
    UMLS CUI [11]
    C0024115
    UMLS CUI [12]
    C0023895
    UMLS CUI [13]
    C0023890
    UMLS CUI [14]
    C0019189
    UMLS CUI [15]
    C0149519
    UMLS CUI [16,1]
    C0012634
    UMLS CUI [16,2]
    C2348568
    UMLS CUI [16,3]
    C1444641
    UMLS CUI [17,1]
    C0012634
    UMLS CUI [17,2]
    C0013230
    UMLS CUI [17,3]
    C1444641
    UMLS CUI [18,1]
    C0012634
    UMLS CUI [18,2]
    C0439801
    UMLS CUI [18,3]
    C0525058
    UMLS CUI [19,1]
    C0012634
    UMLS CUI [19,2]
    C0521102
    UMLS CUI [19,3]
    C0459471
    UMLS CUI [19,4]
    C0683954
    UMLS CUI [20,1]
    C0012634
    UMLS CUI [20,2]
    C2348568
    UMLS CUI [20,3]
    C1548788
    UMLS CUI [21,1]
    C0008679
    UMLS CUI [21,2]
    C2348568
    UMLS CUI [21,3]
    C1444641
    UMLS CUI [22,1]
    C0004936
    UMLS CUI [22,2]
    C2348568
    UMLS CUI [22,3]
    C1444641
    UMLS CUI [23,1]
    C0870281
    UMLS CUI [23,2]
    C2348568
    UMLS CUI [23,3]
    C1444641
    UMLS CUI [24,1]
    C0748872
    UMLS CUI [24,2]
    C2348568
    UMLS CUI [24,3]
    C1444641
    UMLS CUI [25,1]
    C1853129
    UMLS CUI [25,2]
    C2348568
    UMLS CUI [25,3]
    C1444641
    8. known or suspected hypersensitivity to study treatments.
    Descripción

    Hypersensitivity Investigational Therapies | Hypersensitivity Suspected Investigational Therapies

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0949266
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0750491
    UMLS CUI [2,3]
    C0949266
    9. history of hiv or hepatitis c
    Descripción

    HIV Infection | Hepatitis C

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0019693
    UMLS CUI [2]
    C0019196
    10. individuals with a history of a different malignancy, other than treated cervical cancer in situ, basal cell or squamous cell carcinoma of the skin, are ineligible, except if they have been disease-free for at least 5 years, and are deemed by the investigator to be at low risk for recurrence of that malignancy or other primary malignancy is neither currently clinically significant nor requiring active intervention.
    Descripción

    Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Disease Free Duration | Exception Low Risk Recurrent tumor

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1707251
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0851140
    UMLS CUI [2,3]
    C1522326
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0007117
    UMLS CUI [3,3]
    C1522326
    UMLS CUI [4,1]
    C1705847
    UMLS CUI [4,2]
    C0553723
    UMLS CUI [4,3]
    C1522326
    UMLS CUI [5,1]
    C1705847
    UMLS CUI [5,2]
    C0012634
    UMLS CUI [5,3]
    C0332296
    UMLS CUI [5,4]
    C0449238
    UMLS CUI [6,1]
    C1705847
    UMLS CUI [6,2]
    C3538919
    UMLS CUI [6,3]
    C0521158
    11. pregnant or lactating women.
    Descripción

    Pregnancy | Breast Feeding

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    12. women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of ofatumumab therapy. adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence. women of childbearing potential must have a negative pregnancy test prior at screening.
    Descripción

    Childbearing Potential Contraceptive methods Unable | Childbearing Potential Contraceptive methods Unwilling | Premenopausal state Contraceptive methods Unable | Premenopausal state Contraceptive methods Unwilling | Hormonal contraception | Intrauterine Devices | Barrier Contraception Double | Sexual Abstinence | Childbearing Potential Pregnancy test negative

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0700589
    UMLS CUI [1,3]
    C1299582
    UMLS CUI [2,1]
    C3831118
    UMLS CUI [2,2]
    C0700589
    UMLS CUI [2,3]
    C0558080
    UMLS CUI [3,1]
    C0232969
    UMLS CUI [3,2]
    C0700589
    UMLS CUI [3,3]
    C1299582
    UMLS CUI [4,1]
    C0232969
    UMLS CUI [4,2]
    C0700589
    UMLS CUI [4,3]
    C0558080
    UMLS CUI [5]
    C2985296
    UMLS CUI [6]
    C0021900
    UMLS CUI [7,1]
    C0004764
    UMLS CUI [7,2]
    C0205173
    UMLS CUI [8]
    C0036899
    UMLS CUI [9,1]
    C3831118
    UMLS CUI [9,2]
    C0427780
    13. male subjects unable or unwilling to use adequate contraception methods from the time of first dose of study medication until one year after the last dose of ofatumumab.
    Descripción

    Gender Contraceptive methods Unable | Gender Contraceptive methods Unwilling

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0079399
    UMLS CUI [1,2]
    C0700589
    UMLS CUI [1,3]
    C1299582
    UMLS CUI [2,1]
    C0079399
    UMLS CUI [2,2]
    C0700589
    UMLS CUI [2,3]
    C0558080
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    Similar models

    Eligibility Diffuse Large B-cell Lymphoma NCT02412267

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Diffuse large B-cell lymphoma refractory CD20 positive | Diffuse large B-cell lymphoma recurrent CD20 positive | Status post Combined Modality Therapy | rituximab | Chemotherapy
    Item
    1. refractory or relapsed cd20 positive dlbcl following rituximab combined with chemotherapy.
    boolean
    C0855112 (UMLS CUI [1,1])
    C3888518 (UMLS CUI [1,2])
    C0855111 (UMLS CUI [2,1])
    C3888518 (UMLS CUI [2,2])
    C0231290 (UMLS CUI [3,1])
    C0009429 (UMLS CUI [3,2])
    C0393022 (UMLS CUI [4])
    C0392920 (UMLS CUI [5])
    Measurable Disease
    Item
    2. participants must have measurable disease
    boolean
    C1513041 (UMLS CUI [1])
    ECOG performance status
    Item
    3. ecog performance status 0-2
    boolean
    C1520224 (UMLS CUI [1])
    Exception Involvement Lymphomatous | Organ function | Bone Marrow function
    Item
    4. unless due to lymphomatous involvement, participants must have adequate organ and marrow function as defined below:
    boolean
    C1705847 (UMLS CUI [1,1])
    C1314939 (UMLS CUI [1,2])
    C0024299 (UMLS CUI [1,3])
    C0678852 (UMLS CUI [2])
    C0005953 (UMLS CUI [3,1])
    C0031843 (UMLS CUI [3,2])
    Hemoglobin measurement
    Item
    hemoglobin ≥ 10g/dl
    boolean
    C0518015 (UMLS CUI [1])
    Absolute neutrophil count
    Item
    absolute neutrophil count ≥ 1500/mm3
    boolean
    C0948762 (UMLS CUI [1])
    Platelet Count measurement
    Item
    platelets ≥ 100 000/mm3
    boolean
    C0032181 (UMLS CUI [1])
    Alanine aminotransferase measurement | Aspartate aminotransferase measurement
    Item
    alt and ast ≤ 3 x upper limit of normal (uln),
    boolean
    C0201836 (UMLS CUI [1])
    C0201899 (UMLS CUI [2])
    Serum total bilirubin measurement
    Item
    total serum bilirubin ≤ 1.5 x uln
    boolean
    C1278039 (UMLS CUI [1])
    Creatinine measurement, serum
    Item
    serum creatinine ≤ 1.5 x uln
    boolean
    C0201976 (UMLS CUI [1])
    Effects of Cancer treatment | Patient recovered CTCAE Grades | Return to Baseline | Irreversible toxic effect Assessed
    Item
    5. fully recovered (≤ grade 1 or returned to baseline or deemed irreversible) from the acute effects of prior cancer therapy before initiation of study drug
    boolean
    C1704420 (UMLS CUI [1,1])
    C0920425 (UMLS CUI [1,2])
    C1115804 (UMLS CUI [2,1])
    C1516728 (UMLS CUI [2,2])
    C0332156 (UMLS CUI [3,1])
    C1442488 (UMLS CUI [3,2])
    C0678774 (UMLS CUI [4,1])
    C1516048 (UMLS CUI [4,2])
    Informed Consent
    Item
    6. ability to understand and the willingness to sign a written informed consent document
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Cancer treatment Lymphoma | Exception Combined Modality Therapy | rituximab | Chemotherapy
    Item
    1. any previous cancer therapy for lymphoma, with the exception of rituximab in combination with chemotherapy (not more than 1 prior line of chemotherapy)
    boolean
    C0920425 (UMLS CUI [1,1])
    C0024299 (UMLS CUI [1,2])
    C1705847 (UMLS CUI [2,1])
    C0009429 (UMLS CUI [2,2])
    C0393022 (UMLS CUI [3])
    C0392920 (UMLS CUI [4])
    Cancer treatment Systemic | Nitrosoureas | Mitomycin
    Item
    2. participants who have had systemic anti-cancer therapy within 3 weeks (8 weeks for nitrosoureas or mitomycin c) prior to study entry
    boolean
    C0920425 (UMLS CUI [1,1])
    C0205373 (UMLS CUI [1,2])
    C0028210 (UMLS CUI [2])
    C0002475 (UMLS CUI [3])
    Therapeutic radiology procedure | Major surgery
    Item
    3. participants who have had radiotherapy and/ or major surgery within 3 weeks prior to study entry
    boolean
    C1522449 (UMLS CUI [1])
    C0679637 (UMLS CUI [2])
    CORTICOSTEROIDS FOR SYSTEMIC USE Treating Lymphoma
    Item
    4. participants who have had systemic corticosteroids for the purpose of treating lymphoma within 2 weeks prior to study entry are ineligible. patients receiving stable (not increased within the last month) chronic doses of systemic corticosteroids with a maximum dose of 20 mg of prednisolone (or equivalent) per day are eligible if they are being given for disorders other than lymphoma
    boolean
    C3653708 (UMLS CUI [1,1])
    C1522326 (UMLS CUI [1,2])
    C0024299 (UMLS CUI [1,3])
    Cancer treatment | Investigational New Drugs
    Item
    5. concurrent use of any other anti-cancer therapies or study agents.
    boolean
    C0920425 (UMLS CUI [1])
    C0013230 (UMLS CUI [2])
    Primary cerebral lymphoma Symptomatic | Primary cerebral lymphoma Uncontrolled | Primary central nervous system lymphoma Symptomatic | Primary central nervous system lymphoma Uncontrolled
    Item
    6. presence of symptomatic or uncontrolled brain or central nervous system lymphomatous lesions
    boolean
    C0240803 (UMLS CUI [1,1])
    C0231220 (UMLS CUI [1,2])
    C0240803 (UMLS CUI [2,1])
    C0205318 (UMLS CUI [2,2])
    C0280803 (UMLS CUI [3,1])
    C0231220 (UMLS CUI [3,2])
    C0280803 (UMLS CUI [4,1])
    C0205318 (UMLS CUI [4,2])
    Comorbidity Uncontrolled | Communicable Disease | Heart Disease | Medical History Heart Disease | Congestive heart failure New York Heart Association Classification | Angina, Unstable | New onset angina | Myocardial Infarction | Cardiac Arrhythmia | Requirement Anti-Arrhythmia Agents | Lung disease | Liver disease | Liver Cirrhosis | Hepatitis, Chronic | Chronic Persistent Hepatitis | Disease Study Subject Participation Status At risk | Disease Investigational New Drugs At risk | Disease Limiting Protocol Compliance | Disease Interferes with Interpretation Research results | Disease Study Subject Participation Status Inappropriate | Chronic disease Study Subject Participation Status At risk | Mental disorders Study Subject Participation Status At risk | Chronic mental disorder Study Subject Participation Status At risk | Social situation Study Subject Participation Status At risk | LABORATORY ABNORMALITIES Study Subject Participation Status At risk
    Item
    7. uncontrolled intercurrent illness including, but not limited to ongoing or active infection, clinically significant cardiac disease including a history of cardiac disease or congestive heart failure > nyha class 2, unstable angina (anginal symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months, significant cardiac arrhythmias and/ or requiring anti-arrhythmics; pulmonary disease; liver diseases such as cirrhosis, chronic active or persistent hepatitis; or acute/ chronic medical/ psychiatric illness/ social situations or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or limit compliance with study requirements, or interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
    boolean
    C0009488 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    C0009450 (UMLS CUI [2])
    C0018799 (UMLS CUI [3])
    C0262926 (UMLS CUI [4,1])
    C0018799 (UMLS CUI [4,2])
    C0018802 (UMLS CUI [5,1])
    C1275491 (UMLS CUI [5,2])
    C0002965 (UMLS CUI [6])
    C0340289 (UMLS CUI [7])
    C0027051 (UMLS CUI [8])
    C0003811 (UMLS CUI [9])
    C1514873 (UMLS CUI [10,1])
    C0003195 (UMLS CUI [10,2])
    C0024115 (UMLS CUI [11])
    C0023895 (UMLS CUI [12])
    C0023890 (UMLS CUI [13])
    C0019189 (UMLS CUI [14])
    C0149519 (UMLS CUI [15])
    C0012634 (UMLS CUI [16,1])
    C2348568 (UMLS CUI [16,2])
    C1444641 (UMLS CUI [16,3])
    C0012634 (UMLS CUI [17,1])
    C0013230 (UMLS CUI [17,2])
    C1444641 (UMLS CUI [17,3])
    C0012634 (UMLS CUI [18,1])
    C0439801 (UMLS CUI [18,2])
    C0525058 (UMLS CUI [18,3])
    C0012634 (UMLS CUI [19,1])
    C0521102 (UMLS CUI [19,2])
    C0459471 (UMLS CUI [19,3])
    C0683954 (UMLS CUI [19,4])
    C0012634 (UMLS CUI [20,1])
    C2348568 (UMLS CUI [20,2])
    C1548788 (UMLS CUI [20,3])
    C0008679 (UMLS CUI [21,1])
    C2348568 (UMLS CUI [21,2])
    C1444641 (UMLS CUI [21,3])
    C0004936 (UMLS CUI [22,1])
    C2348568 (UMLS CUI [22,2])
    C1444641 (UMLS CUI [22,3])
    C0870281 (UMLS CUI [23,1])
    C2348568 (UMLS CUI [23,2])
    C1444641 (UMLS CUI [23,3])
    C0748872 (UMLS CUI [24,1])
    C2348568 (UMLS CUI [24,2])
    C1444641 (UMLS CUI [24,3])
    C1853129 (UMLS CUI [25,1])
    C2348568 (UMLS CUI [25,2])
    C1444641 (UMLS CUI [25,3])
    Hypersensitivity Investigational Therapies | Hypersensitivity Suspected Investigational Therapies
    Item
    8. known or suspected hypersensitivity to study treatments.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0949266 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0750491 (UMLS CUI [2,2])
    C0949266 (UMLS CUI [2,3])
    HIV Infection | Hepatitis C
    Item
    9. history of hiv or hepatitis c
    boolean
    C0019693 (UMLS CUI [1])
    C0019196 (UMLS CUI [2])
    Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Disease Free Duration | Exception Low Risk Recurrent tumor
    Item
    10. individuals with a history of a different malignancy, other than treated cervical cancer in situ, basal cell or squamous cell carcinoma of the skin, are ineligible, except if they have been disease-free for at least 5 years, and are deemed by the investigator to be at low risk for recurrence of that malignancy or other primary malignancy is neither currently clinically significant nor requiring active intervention.
    boolean
    C1707251 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0851140 (UMLS CUI [2,2])
    C1522326 (UMLS CUI [2,3])
    C1705847 (UMLS CUI [3,1])
    C0007117 (UMLS CUI [3,2])
    C1522326 (UMLS CUI [3,3])
    C1705847 (UMLS CUI [4,1])
    C0553723 (UMLS CUI [4,2])
    C1522326 (UMLS CUI [4,3])
    C1705847 (UMLS CUI [5,1])
    C0012634 (UMLS CUI [5,2])
    C0332296 (UMLS CUI [5,3])
    C0449238 (UMLS CUI [5,4])
    C1705847 (UMLS CUI [6,1])
    C3538919 (UMLS CUI [6,2])
    C0521158 (UMLS CUI [6,3])
    Pregnancy | Breast Feeding
    Item
    11. pregnant or lactating women.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Childbearing Potential Contraceptive methods Unable | Childbearing Potential Contraceptive methods Unwilling | Premenopausal state Contraceptive methods Unable | Premenopausal state Contraceptive methods Unwilling | Hormonal contraception | Intrauterine Devices | Barrier Contraception Double | Sexual Abstinence | Childbearing Potential Pregnancy test negative
    Item
    12. women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of ofatumumab therapy. adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence. women of childbearing potential must have a negative pregnancy test prior at screening.
    boolean
    C3831118 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    C1299582 (UMLS CUI [1,3])
    C3831118 (UMLS CUI [2,1])
    C0700589 (UMLS CUI [2,2])
    C0558080 (UMLS CUI [2,3])
    C0232969 (UMLS CUI [3,1])
    C0700589 (UMLS CUI [3,2])
    C1299582 (UMLS CUI [3,3])
    C0232969 (UMLS CUI [4,1])
    C0700589 (UMLS CUI [4,2])
    C0558080 (UMLS CUI [4,3])
    C2985296 (UMLS CUI [5])
    C0021900 (UMLS CUI [6])
    C0004764 (UMLS CUI [7,1])
    C0205173 (UMLS CUI [7,2])
    C0036899 (UMLS CUI [8])
    C3831118 (UMLS CUI [9,1])
    C0427780 (UMLS CUI [9,2])
    Gender Contraceptive methods Unable | Gender Contraceptive methods Unwilling
    Item
    13. male subjects unable or unwilling to use adequate contraception methods from the time of first dose of study medication until one year after the last dose of ofatumumab.
    boolean
    C0079399 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    C1299582 (UMLS CUI [1,3])
    C0079399 (UMLS CUI [2,1])
    C0700589 (UMLS CUI [2,2])
    C0558080 (UMLS CUI [2,3])
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