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ID

12103

Beskrivning

Combination of Lenalidomide and Obinutuzumab (GA101) in Patients With Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL); ODM derived from: https://clinicaltrials.gov/show/NCT02225275

Länk

https://clinicaltrials.gov/show/NCT02225275

Nyckelord

Versioner (2)
  1. 2015-09-23 2015-09-23 - Julian Varghese
  2. 2015-09-23 2015-09-23 - Julian Varghese
Uppladdad den

23 september 2015

DOI

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Licens

Creative Commons BY 4.0
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    Eligibility Leukemia NCT02225275

    Engelsk

    Eligibility Leukemia NCT02225275

    1 Formulär  
    1. StudyEvent: Eligibility
      1. Eligibility Leukemia NCT02225275
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. age 18 years or older at the time of signing informed consent. able to understand and to provide voluntarily informed consent;
    Beskrivning

    Age | Informed Consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2]
    C0021430
    2. have documented cll/sll according to nci criteria;
    Beskrivning

    Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023434
    UMLS CUI [2]
    C0855095
    3. recurrent or refractory disease according to nci criteria;
    Beskrivning

    Refractory Disease | Recurrent disease | leukemia

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1514815
    UMLS CUI [2]
    C0277556
    UMLS CUI [3]
    C0023418
    4. patient are eligible if they have received one or more prior treatment;
    Beskrivning

    prior treatment; one

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463
    UMLS CUI [1,2]
    C0023434
    UMLS CUI [2,1]
    C1514463
    UMLS CUI [2,2]
    C0855095
    5. ecog performance status of 0-2 (appendix 1);
    Beskrivning

    ecog performance status; appendix

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    6. life expectancy > 6 months;
    Beskrivning

    life expectancy > 6 months

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    7. adequate renal function indicated by serum creatinine less or equal to 2 mg/dl;
    Beskrivning

    adequate renal function; serum creatinine

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    8. adequate hepatic function indicated as total bilirubin less or equal to 2 mg/dl and alt/gpt less or equal to two times the upper normal limit;
    Beskrivning

    adequate hepatic function; total bilirubin;

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0201913
    9. disease free of prior malignancies for 3 years with exception of currently treated basal cell squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast. patients with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery can be enrolled in the study as long as they have a reasonable expectation to have been cured with the treatment modality received
    Beskrivning

    disease free of prior malignancies for >/= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast.; disease free of prior malignancies for ? 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2]
    C0553723
    UMLS CUI [3]
    C0851140
    UMLS CUI [4]
    C0154084
    10. no prior history of myelodysplastic syndrome or other myeloid malignancy;
    Beskrivning

    MYELODYSPLASTIC SYNDROME | Myeloid neoplasm

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3463824
    UMLS CUI [2]
    C2939461
    11. all participants must be registered into the mandatory revlimid rems® program, and be willing and able to comply with the requirements of the revlimid rems ®;
    Beskrivning

    able to comply with the requirements of the protocol.; able to comply with the protocol; participants; all

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0421512
    UMLS CUI [2]
    C1321605
    12. females of childbearing potential (fcbp) must have a negative serum and/or urine pregnancy test with a sensitive of at least 50 miu/ml within 10-14 days and again within 24 hours prior to prescribe lenalidomide for cycle 1 (prescriptions must be filled within 7 days as required by revlimid rems) and must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least 28 days before she starts taking lenalidomide. fcbp must also agree to ongoing pregnancy testing. men must agree to use a latex condom during sexual contact with a fcbp even if they have had a successful vasectomy.
    Beskrivning

    childbearing potential; pregnancy test; lenalidomide; negative; ongoing; testing; method; sexual; agree; serum; begin; urine; cycle; latex; time; from; miu; one

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0700589
    UMLS CUI [2]
    C0430064
    UMLS CUI [3]
    C0430056
    UMLS CUI [4]
    C0036899
    UMLS CUI [5]
    C0700589
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. known sensitivity to lenalidomide or other thalidomide derivatives or anti cd20;
    Beskrivning

    Sensitivity to lenalidomide; thalidomide;

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1144149
    UMLS CUI [1,2]
    C0332324
    UMLS CUI [2,1]
    C0039736
    UMLS CUI [2,2]
    C0332324
    UMLS CUI [3,1]
    C2742503
    UMLS CUI [3,2]
    C0332324
    2. documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood);
    Beskrivning

    prolymphocytic leukemia; prolymphocytes; blood

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023486
    3. known history of infection with human immunodeficiency virus (hiv) or human t cell leukemia virus 1 (htlv-1);
    Beskrivning

    HIV | Human T-lymphotropic virus 1

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0019682
    UMLS CUI [2]
    C0020094
    4. serologic status reflecting active hepatitis b or c. patients with hepatitis b (hbv) antibody positive but who have positivity for hepatitis b surface antigen (hbsag) or anti hepatitis b core antibody (anti-hbc) and patients who are positive for anti-hcv will need to have a negative pcr (viral hbv dna or hcv rna) result prior to enrollment. those who are hbsag positive or hbv dna positive and those who are positive for hcv (rna) will be excluded;
    Beskrivning

    Hepatitis B | Hepatitis C

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0019163
    UMLS CUI [2]
    C0019196
    5. pregnant or breast feeding females;
    Beskrivning

    pregnant or breast feeding woman; pregnant or breast feeding women

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0549206
    UMLS CUI [2]
    C0006147
    6. history of tuberculosis treated within the last five years or recent exposure to tuberculosis;
    Beskrivning

    tuberculosis; exposure; last

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0041296
    7. any serious medical condition, laboratory abnormality, or psychiatric illness that places the subject unacceptable risk if he/she were to participate to the study;
    Beskrivning

    medical condition; patient risk management

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0814475
    8. patients with a recent history of deep vein thrombosis or pulmonary embolus, in the six months prior to enrollment are not eligible for this study.
    Beskrivning

    Deep Vein Thrombosis | Pulmonary Embolism

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0149871
    UMLS CUI [2]
    C0034065
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    Similar models

    Eligibility Leukemia NCT02225275

    1 Formulär
    1. StudyEvent: Eligibility
      1. Eligibility Leukemia NCT02225275
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age | Informed Consent
    Item
    1. age 18 years or older at the time of signing informed consent. able to understand and to provide voluntarily informed consent;
    boolean
    C0001779 (UMLS CUI [1])
    C0021430 (UMLS CUI [2])
    Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma
    Item
    2. have documented cll/sll according to nci criteria;
    boolean
    C0023434 (UMLS CUI [1])
    C0855095 (UMLS CUI [2])
    Refractory Disease | Recurrent disease | leukemia
    Item
    3. recurrent or refractory disease according to nci criteria;
    boolean
    C1514815 (UMLS CUI [1])
    C0277556 (UMLS CUI [2])
    C0023418 (UMLS CUI [3])
    prior treatment; one
    Item
    4. patient are eligible if they have received one or more prior treatment;
    boolean
    C1514463 (UMLS CUI [1,1])
    C0023434 (UMLS CUI [1,2])
    C1514463 (UMLS CUI [2,1])
    C0855095 (UMLS CUI [2,2])
    ecog performance status; appendix
    Item
    5. ecog performance status of 0-2 (appendix 1);
    boolean
    C1520224 (UMLS CUI [1])
    life expectancy > 6 months
    Item
    6. life expectancy > 6 months;
    boolean
    C0023671 (UMLS CUI [1])
    adequate renal function; serum creatinine
    Item
    7. adequate renal function indicated by serum creatinine less or equal to 2 mg/dl;
    boolean
    C0201976 (UMLS CUI [1])
    adequate hepatic function; total bilirubin;
    Item
    8. adequate hepatic function indicated as total bilirubin less or equal to 2 mg/dl and alt/gpt less or equal to two times the upper normal limit;
    boolean
    C0201913 (UMLS CUI [1])
    disease free of prior malignancies for >/= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast.; disease free of prior malignancies for ? 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma
    Item
    9. disease free of prior malignancies for 3 years with exception of currently treated basal cell squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast. patients with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery can be enrolled in the study as long as they have a reasonable expectation to have been cured with the treatment modality received
    boolean
    C0006826 (UMLS CUI [1])
    C0553723 (UMLS CUI [2])
    C0851140 (UMLS CUI [3])
    C0154084 (UMLS CUI [4])
    MYELODYSPLASTIC SYNDROME | Myeloid neoplasm
    Item
    10. no prior history of myelodysplastic syndrome or other myeloid malignancy;
    boolean
    C3463824 (UMLS CUI [1])
    C2939461 (UMLS CUI [2])
    able to comply with the requirements of the protocol.; able to comply with the protocol; participants; all
    Item
    11. all participants must be registered into the mandatory revlimid rems® program, and be willing and able to comply with the requirements of the revlimid rems ®;
    boolean
    C0421512 (UMLS CUI [1])
    C1321605 (UMLS CUI [2])
    childbearing potential; pregnancy test; lenalidomide; negative; ongoing; testing; method; sexual; agree; serum; begin; urine; cycle; latex; time; from; miu; one
    Item
    12. females of childbearing potential (fcbp) must have a negative serum and/or urine pregnancy test with a sensitive of at least 50 miu/ml within 10-14 days and again within 24 hours prior to prescribe lenalidomide for cycle 1 (prescriptions must be filled within 7 days as required by revlimid rems) and must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least 28 days before she starts taking lenalidomide. fcbp must also agree to ongoing pregnancy testing. men must agree to use a latex condom during sexual contact with a fcbp even if they have had a successful vasectomy.
    boolean
    C0700589 (UMLS CUI [1])
    C0430064 (UMLS CUI [2])
    C0430056 (UMLS CUI [3])
    C0036899 (UMLS CUI [4])
    C0700589 (UMLS CUI [5])
    Item Group
    C0680251 (UMLS CUI)
    Sensitivity to lenalidomide; thalidomide;
    Item
    1. known sensitivity to lenalidomide or other thalidomide derivatives or anti cd20;
    boolean
    C1144149 (UMLS CUI [1,1])
    C0332324 (UMLS CUI [1,2])
    C0039736 (UMLS CUI [2,1])
    C0332324 (UMLS CUI [2,2])
    C2742503 (UMLS CUI [3,1])
    C0332324 (UMLS CUI [3,2])
    prolymphocytic leukemia; prolymphocytes; blood
    Item
    2. documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood);
    boolean
    C0023486 (UMLS CUI [1])
    HIV | Human T-lymphotropic virus 1
    Item
    3. known history of infection with human immunodeficiency virus (hiv) or human t cell leukemia virus 1 (htlv-1);
    boolean
    C0019682 (UMLS CUI [1])
    C0020094 (UMLS CUI [2])
    Hepatitis B | Hepatitis C
    Item
    4. serologic status reflecting active hepatitis b or c. patients with hepatitis b (hbv) antibody positive but who have positivity for hepatitis b surface antigen (hbsag) or anti hepatitis b core antibody (anti-hbc) and patients who are positive for anti-hcv will need to have a negative pcr (viral hbv dna or hcv rna) result prior to enrollment. those who are hbsag positive or hbv dna positive and those who are positive for hcv (rna) will be excluded;
    boolean
    C0019163 (UMLS CUI [1])
    C0019196 (UMLS CUI [2])
    pregnant or breast feeding woman; pregnant or breast feeding women
    Item
    5. pregnant or breast feeding females;
    boolean
    C0549206 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    tuberculosis; exposure; last
    Item
    6. history of tuberculosis treated within the last five years or recent exposure to tuberculosis;
    boolean
    C0041296 (UMLS CUI [1])
    medical condition; patient risk management
    Item
    7. any serious medical condition, laboratory abnormality, or psychiatric illness that places the subject unacceptable risk if he/she were to participate to the study;
    boolean
    C0814475 (UMLS CUI [1])
    Deep Vein Thrombosis | Pulmonary Embolism
    Item
    8. patients with a recent history of deep vein thrombosis or pulmonary embolus, in the six months prior to enrollment are not eligible for this study.
    boolean
    C0149871 (UMLS CUI [1])
    C0034065 (UMLS CUI [2])
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