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ID

41032

Beschrijving

Ofatumumab vs Physician's Choice in Subjects With Bulky Fludarabine-Refractory Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01313689

Link

https://clinicaltrials.gov/show/NCT01313689

Trefwoorden

Versies (1)
  1. 15-06-20 15-06-20 -
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See clinicaltrials.gov

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15 juni 2020

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Creative Commons BY 4.0
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    Eligibility Leukaemia, Lymphocytic, Chronic NCT01313689

    Engels

    Eligibility Leukaemia, Lymphocytic, Chronic NCT01313689

    1 Formulieren  
    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    adults with documented diagnosis of active cll requiring treatment
    Beschrijving

    Adult | Chronic Lymphocytic Leukemia Treatment required for

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001675
    UMLS CUI [2,1]
    C0023434
    UMLS CUI [2,2]
    C0332121
    bulky lymphadenopathy, defined as at least 1 lymph node >5 cm
    Beschrijving

    Lymphadenopathy Bulky | Lymph node Size Quantity

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0497156
    UMLS CUI [1,2]
    C0555954
    UMLS CUI [2,1]
    C0024204
    UMLS CUI [2,2]
    C0456389
    UMLS CUI [2,3]
    C1265611
    must be refractory to fludarabine treatment
    Beschrijving

    Unresponsive to Fludarabine

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0205269
    UMLS CUI [1,2]
    C0059985
    age 18 yrs or older
    Beschrijving

    Age

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    at least 2 prior therapies for cll
    Beschrijving

    Prior Therapy Quantity CLL

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463
    UMLS CUI [1,2]
    C1265611
    UMLS CUI [1,3]
    C0023434
    eastern cooperative oncology group (ecog) performance status of 0-2
    Beschrijving

    ECOG performance status

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    signed written informed consent
    Beschrijving

    Informed Consent

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    prior allogeneic stem cell transplant at any time, or autologous stem cell transplant within 6 months
    Beschrijving

    Allogeneic hematopoietic stem cell transplant | Autologous hematopoietic stem cell transplant

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C4255274
    UMLS CUI [2]
    C2193200
    treatment with any unapproved drug substance or experimental therapy within 4 weeks, or currently participating in another interventional clinical study
    Beschrijving

    Drugs, Non-Prescription | Therapy, Investigational | Study Subject Participation Status | Interventional Study

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0013231
    UMLS CUI [2]
    C0949266
    UMLS CUI [3]
    C2348568
    UMLS CUI [4]
    C3274035
    cll transformation, prolymphocytic leukemia, or central nervous system (cns) involvement of cll
    Beschrijving

    Chronic lymphocytic leukaemia transformation | Prolymphocytic Leukemia | Central Nervous System Involvement CLL

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1142081
    UMLS CUI [2]
    C0023486
    UMLS CUI [3,1]
    C4050309
    UMLS CUI [3,2]
    C0023434
    active autoimmune hemolytic anemia (aiha) requiring treatment except if associated with progressive disease requiring anti-cll treatment
    Beschrijving

    Autoimmune hemolytic anemia Treatment required for

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0002880
    UMLS CUI [1,2]
    C0332121
    chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment
    Beschrijving

    Chronic infectious disease | Communicable Disease | Requirement Antibiotics for systemic use | Requirement Antifungal treatment | Requirement Antiviral treatment

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0151317
    UMLS CUI [2]
    C0009450
    UMLS CUI [3,1]
    C1514873
    UMLS CUI [3,2]
    C3540704
    UMLS CUI [4,1]
    C1514873
    UMLS CUI [4,2]
    C2363963
    UMLS CUI [5,1]
    C1514873
    UMLS CUI [5,2]
    C2363964
    human immunodeficiency virus (hiv) positive
    Beschrijving

    HIV Seropositivity

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0019699
    significant concurrent, uncontrolled medical condition
    Beschrijving

    Comorbidity Uncontrolled

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0205318
    other past or current malignancy (with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix or breast) unless the tumor was successfully treated with curative intent at least 2 years prior to trial entry
    Beschrijving

    Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of female breast | Exception Cancer treatment Curative Successful

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1707251
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0007117
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0851140
    UMLS CUI [4,1]
    C1705847
    UMLS CUI [4,2]
    C0686288
    UMLS CUI [5,1]
    C1705847
    UMLS CUI [5,2]
    C0920425
    UMLS CUI [5,3]
    C1276305
    UMLS CUI [5,4]
    C1272703
    non-protocol corticosteroid usage except a maintenance dose corresponding to less than or equal to 10 mg prednisone
    Beschrijving

    Adrenal Cortex Hormones | Exception Maintenance Dose | Exception Equivalent Prednisone Dose

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001617
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0024501
    UMLS CUI [2,3]
    C0178602
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0205163
    UMLS CUI [3,3]
    C0032952
    UMLS CUI [3,4]
    C0178602
    abnormal lab values: creatinine > 2.0 times upper normal limit (unless normal creatinine clearance), or total bilirubin > 2.0 times upper normal limit (unless due to liver involvement of cll or due to gilbert's syndrome), or alanine transaminase (alt) > 2.5 times upper normal limit (unless due to liver involvement of cll)
    Beschrijving

    Laboratory test result abnormal | Creatinine increased | Exception Creatinine clearance Normal | Elevated total bilirubin | Exception Liver Involvement with CLL | Exception Gilbert Disease | Alanine aminotransferase increased | Exception Liver Involvement with CLL

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0438215
    UMLS CUI [2]
    C0151578
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0373595
    UMLS CUI [3,3]
    C0205307
    UMLS CUI [4]
    C0741494
    UMLS CUI [5,1]
    C1705847
    UMLS CUI [5,2]
    C0023884
    UMLS CUI [5,3]
    C1314939
    UMLS CUI [5,4]
    C0023434
    UMLS CUI [6,1]
    C1705847
    UMLS CUI [6,2]
    C0017551
    UMLS CUI [7]
    C0151905
    UMLS CUI [8,1]
    C1705847
    UMLS CUI [8,2]
    C0023884
    UMLS CUI [8,3]
    C1314939
    UMLS CUI [8,4]
    C0023434
    known or suspected hypersensitivity to ofatumumab
    Beschrijving

    Hypersensitivity Ofatumumab | Hypersensitivity Suspected Ofatumumab

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C1832027
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0750491
    UMLS CUI [2,3]
    C1832027
    lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception
    Beschrijving

    Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Partner Contraceptive methods Unwilling

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0006147
    UMLS CUI [2]
    C0032961
    UMLS CUI [3,1]
    C3831118
    UMLS CUI [3,2]
    C0700589
    UMLS CUI [3,3]
    C0558080
    UMLS CUI [4,1]
    C3831118
    UMLS CUI [4,2]
    C0682323
    UMLS CUI [4,3]
    C0700589
    UMLS CUI [4,4]
    C0558080
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    Similar models

    Eligibility Leukaemia, Lymphocytic, Chronic NCT01313689

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Adult | Chronic Lymphocytic Leukemia Treatment required for
    Item
    adults with documented diagnosis of active cll requiring treatment
    boolean
    C0001675 (UMLS CUI [1])
    C0023434 (UMLS CUI [2,1])
    C0332121 (UMLS CUI [2,2])
    Lymphadenopathy Bulky | Lymph node Size Quantity
    Item
    bulky lymphadenopathy, defined as at least 1 lymph node >5 cm
    boolean
    C0497156 (UMLS CUI [1,1])
    C0555954 (UMLS CUI [1,2])
    C0024204 (UMLS CUI [2,1])
    C0456389 (UMLS CUI [2,2])
    C1265611 (UMLS CUI [2,3])
    Unresponsive to Fludarabine
    Item
    must be refractory to fludarabine treatment
    boolean
    C0205269 (UMLS CUI [1,1])
    C0059985 (UMLS CUI [1,2])
    Age
    Item
    age 18 yrs or older
    boolean
    C0001779 (UMLS CUI [1])
    Prior Therapy Quantity CLL
    Item
    at least 2 prior therapies for cll
    boolean
    C1514463 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    C0023434 (UMLS CUI [1,3])
    ECOG performance status
    Item
    eastern cooperative oncology group (ecog) performance status of 0-2
    boolean
    C1520224 (UMLS CUI [1])
    Informed Consent
    Item
    signed written informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Allogeneic hematopoietic stem cell transplant | Autologous hematopoietic stem cell transplant
    Item
    prior allogeneic stem cell transplant at any time, or autologous stem cell transplant within 6 months
    boolean
    C4255274 (UMLS CUI [1])
    C2193200 (UMLS CUI [2])
    Drugs, Non-Prescription | Therapy, Investigational | Study Subject Participation Status | Interventional Study
    Item
    treatment with any unapproved drug substance or experimental therapy within 4 weeks, or currently participating in another interventional clinical study
    boolean
    C0013231 (UMLS CUI [1])
    C0949266 (UMLS CUI [2])
    C2348568 (UMLS CUI [3])
    C3274035 (UMLS CUI [4])
    Chronic lymphocytic leukaemia transformation | Prolymphocytic Leukemia | Central Nervous System Involvement CLL
    Item
    cll transformation, prolymphocytic leukemia, or central nervous system (cns) involvement of cll
    boolean
    C1142081 (UMLS CUI [1])
    C0023486 (UMLS CUI [2])
    C4050309 (UMLS CUI [3,1])
    C0023434 (UMLS CUI [3,2])
    Autoimmune hemolytic anemia Treatment required for
    Item
    active autoimmune hemolytic anemia (aiha) requiring treatment except if associated with progressive disease requiring anti-cll treatment
    boolean
    C0002880 (UMLS CUI [1,1])
    C0332121 (UMLS CUI [1,2])
    Chronic infectious disease | Communicable Disease | Requirement Antibiotics for systemic use | Requirement Antifungal treatment | Requirement Antiviral treatment
    Item
    chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment
    boolean
    C0151317 (UMLS CUI [1])
    C0009450 (UMLS CUI [2])
    C1514873 (UMLS CUI [3,1])
    C3540704 (UMLS CUI [3,2])
    C1514873 (UMLS CUI [4,1])
    C2363963 (UMLS CUI [4,2])
    C1514873 (UMLS CUI [5,1])
    C2363964 (UMLS CUI [5,2])
    HIV Seropositivity
    Item
    human immunodeficiency virus (hiv) positive
    boolean
    C0019699 (UMLS CUI [1])
    Comorbidity Uncontrolled
    Item
    significant concurrent, uncontrolled medical condition
    boolean
    C0009488 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of female breast | Exception Cancer treatment Curative Successful
    Item
    other past or current malignancy (with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix or breast) unless the tumor was successfully treated with curative intent at least 2 years prior to trial entry
    boolean
    C1707251 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0007117 (UMLS CUI [2,2])
    C1705847 (UMLS CUI [3,1])
    C0851140 (UMLS CUI [3,2])
    C1705847 (UMLS CUI [4,1])
    C0686288 (UMLS CUI [4,2])
    C1705847 (UMLS CUI [5,1])
    C0920425 (UMLS CUI [5,2])
    C1276305 (UMLS CUI [5,3])
    C1272703 (UMLS CUI [5,4])
    Adrenal Cortex Hormones | Exception Maintenance Dose | Exception Equivalent Prednisone Dose
    Item
    non-protocol corticosteroid usage except a maintenance dose corresponding to less than or equal to 10 mg prednisone
    boolean
    C0001617 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0024501 (UMLS CUI [2,2])
    C0178602 (UMLS CUI [2,3])
    C1705847 (UMLS CUI [3,1])
    C0205163 (UMLS CUI [3,2])
    C0032952 (UMLS CUI [3,3])
    C0178602 (UMLS CUI [3,4])
    Laboratory test result abnormal | Creatinine increased | Exception Creatinine clearance Normal | Elevated total bilirubin | Exception Liver Involvement with CLL | Exception Gilbert Disease | Alanine aminotransferase increased | Exception Liver Involvement with CLL
    Item
    abnormal lab values: creatinine > 2.0 times upper normal limit (unless normal creatinine clearance), or total bilirubin > 2.0 times upper normal limit (unless due to liver involvement of cll or due to gilbert's syndrome), or alanine transaminase (alt) > 2.5 times upper normal limit (unless due to liver involvement of cll)
    boolean
    C0438215 (UMLS CUI [1])
    C0151578 (UMLS CUI [2])
    C1705847 (UMLS CUI [3,1])
    C0373595 (UMLS CUI [3,2])
    C0205307 (UMLS CUI [3,3])
    C0741494 (UMLS CUI [4])
    C1705847 (UMLS CUI [5,1])
    C0023884 (UMLS CUI [5,2])
    C1314939 (UMLS CUI [5,3])
    C0023434 (UMLS CUI [5,4])
    C1705847 (UMLS CUI [6,1])
    C0017551 (UMLS CUI [6,2])
    C0151905 (UMLS CUI [7])
    C1705847 (UMLS CUI [8,1])
    C0023884 (UMLS CUI [8,2])
    C1314939 (UMLS CUI [8,3])
    C0023434 (UMLS CUI [8,4])
    Hypersensitivity Ofatumumab | Hypersensitivity Suspected Ofatumumab
    Item
    known or suspected hypersensitivity to ofatumumab
    boolean
    C0020517 (UMLS CUI [1,1])
    C1832027 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0750491 (UMLS CUI [2,2])
    C1832027 (UMLS CUI [2,3])
    Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Partner Contraceptive methods Unwilling
    Item
    lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception
    boolean
    C0006147 (UMLS CUI [1])
    C0032961 (UMLS CUI [2])
    C3831118 (UMLS CUI [3,1])
    C0700589 (UMLS CUI [3,2])
    C0558080 (UMLS CUI [3,3])
    C3831118 (UMLS CUI [4,1])
    C0682323 (UMLS CUI [4,2])
    C0700589 (UMLS CUI [4,3])
    C0558080 (UMLS CUI [4,4])
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