0 Evaluaciones
ID

41113

Descripción

A Study of Imatinib and Nilotinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase; ODM derived from: https://clinicaltrials.gov/show/NCT02272777

Link

https://clinicaltrials.gov/show/NCT02272777

Palabras clave

Versiones (1)
  1. 25/6/20 25/6/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

25 de junio de 2020

DOI

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Licencia

Creative Commons BY 4.0
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    Eligibility Leukemia NCT02272777

    Inglés

    Eligibility Leukemia NCT02272777

    1 formularios  
    1. StudyEvent: Eligibility
      1. Eligibility Leukemia NCT02272777
    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    patients eligible for inclusion in this extension phase have to meet all of the following criteria:
    Descripción

    Inclusion criteria All Fulfill

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1512693
    UMLS CUI [1,2]
    C0444868
    UMLS CUI [1,3]
    C1550543
    1. patient is currently on treatment in the core study camn107ecn02
    Descripción

    Therapeutic procedure Clinical Trial Specified

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0008976
    UMLS CUI [1,3]
    C0205369
    2. patient who continues to derive benefit more than risk from the study treatment he/she takes in camn107ecn02, in the opinion of the investigator at the end of the study
    Descripción

    Patient Receiving Benefit | Therapeutic procedure Clinical Trial Specified

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C1514756
    UMLS CUI [1,3]
    C0814225
    UMLS CUI [2,1]
    C0087111
    UMLS CUI [2,2]
    C0008976
    UMLS CUI [2,3]
    C0205369
    3. written informed consent must be obtained prior to enrolling in the extension study.
    Descripción

    Informed Consent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patients eligible for this extension phase must not meet any of the following criteria:
    Descripción

    Exclusion Criteria Any Fulfill

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0680251
    UMLS CUI [1,2]
    C1552551
    UMLS CUI [1,3]
    C1550543
    1. progression to cml-ap or bc
    Descripción

    Progression Accelerated phase chronic myologenic leukemia | Progression Chronic myelogenous leukemia with crisis of blast cells

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0449258
    UMLS CUI [1,2]
    C0919870
    UMLS CUI [2,1]
    C0449258
    UMLS CUI [2,2]
    C2861579
    2. patient whose treatment assigned in camn107ecn02 is not appropriate any longer, per investigator's assessment.
    Descripción

    Therapeutic procedure Clinical Trial Specified Inappropriate

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0008976
    UMLS CUI [1,3]
    C0205369
    UMLS CUI [1,4]
    C1548788
    3. history of non-compliance to medical regimens, or patients who are considered potentially unreliable and/or not cooperative.
    Descripción

    Treatment Compliance Lacking | Unreliable behavior | Uncooperative behavior

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C4319828
    UMLS CUI [1,2]
    C0332268
    UMLS CUI [2]
    C4061925
    UMLS CUI [3]
    C0424350
    4. women who are (a) pregnant and (b) women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and at least 14 days after last dose of study medication. highly effective contraception methods include:
    Descripción

    Pregnancy | Childbearing Potential | Exception Childbearing Potential Contraceptive methods

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C3831118
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C3831118
    UMLS CUI [3,3]
    C0700589
    total abstinence (when this is in line with the preferred and usual lifestyle of the subject. periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
    Descripción

    Total abstinence | Periodic abstinence | Rhythm method of contraception | Oral contraception | Temperature method of contraception | Withdrawal - birth control

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0234008
    UMLS CUI [2]
    C1256761
    UMLS CUI [3]
    C0035513
    UMLS CUI [4]
    C0029151
    UMLS CUI [5]
    C0419534
    UMLS CUI [6]
    C3812880
    female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
    Descripción

    Female Sterilization | Bilateral oophorectomy | Hysterectomy | Tubal Ligation

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0015787
    UMLS CUI [2]
    C0278321
    UMLS CUI [3]
    C0020699
    UMLS CUI [4]
    C0520483
    male sterilization (at least 6 months prior to screening). for female subjects on the study the vasectomized male partner should be the sole partner for that subject.
    Descripción

    Male sterilization | Partner had vasectomy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0024559
    UMLS CUI [2]
    C0420842
    combination of any two of the following (a+b or a+c, or b+c):
    Descripción

    Combination Criteria

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0205195
    UMLS CUI [1,2]
    C0243161
    1. use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.
    Descripción

    Oral contraception | Injectable contraception | Contraceptive implant | Hormonal Contraception | Vaginal ring contraceptive method | Transdermal patch as birth control method

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0029151
    UMLS CUI [2]
    C1262153
    UMLS CUI [3]
    C1657106
    UMLS CUI [4]
    C2985296
    UMLS CUI [5]
    C4761166
    UMLS CUI [6]
    C2135981
    2. placement of an intrauterine device (iud) or intrauterine system (ius)
    Descripción

    Placement of intra-uterine device (IUD) | Placement Intrauterine System

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C3514961
    UMLS CUI [2,1]
    C1533810
    UMLS CUI [2,2]
    C4293370
    3. barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository in case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
    Descripción

    Contraception, Barrier | Female Condoms | Diaphragm/cervical cap | Spermicidal foam/jelly/cream/film/suppository | Oral contraception

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0004764
    UMLS CUI [2]
    C0221829
    UMLS CUI [3]
    C3840973
    UMLS CUI [4]
    C3843415
    UMLS CUI [5]
    C0029151
    women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
    Descripción

    Postmenopausal state | Childbearing Potential Absent | Amenorrhea | Bilateral oophorectomy | Hysterectomy | Tubal Ligation

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0232970
    UMLS CUI [2,1]
    C3831118
    UMLS CUI [2,2]
    C0332197
    UMLS CUI [3]
    C0002453
    UMLS CUI [4]
    C0278321
    UMLS CUI [5]
    C0020699
    UMLS CUI [6]
    C0520483
    Volver a la parte superior de la página

    Similar models

    Eligibility Leukemia NCT02272777

    1 formularios
    1. StudyEvent: Eligibility
      1. Eligibility Leukemia NCT02272777
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Inclusion criteria All Fulfill
    Item
    patients eligible for inclusion in this extension phase have to meet all of the following criteria:
    boolean
    C1512693 (UMLS CUI [1,1])
    C0444868 (UMLS CUI [1,2])
    C1550543 (UMLS CUI [1,3])
    Therapeutic procedure Clinical Trial Specified
    Item
    1. patient is currently on treatment in the core study camn107ecn02
    boolean
    C0087111 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    C0205369 (UMLS CUI [1,3])
    Patient Receiving Benefit | Therapeutic procedure Clinical Trial Specified
    Item
    2. patient who continues to derive benefit more than risk from the study treatment he/she takes in camn107ecn02, in the opinion of the investigator at the end of the study
    boolean
    C0030705 (UMLS CUI [1,1])
    C1514756 (UMLS CUI [1,2])
    C0814225 (UMLS CUI [1,3])
    C0087111 (UMLS CUI [2,1])
    C0008976 (UMLS CUI [2,2])
    C0205369 (UMLS CUI [2,3])
    Informed Consent
    Item
    3. written informed consent must be obtained prior to enrolling in the extension study.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Exclusion Criteria Any Fulfill
    Item
    patients eligible for this extension phase must not meet any of the following criteria:
    boolean
    C0680251 (UMLS CUI [1,1])
    C1552551 (UMLS CUI [1,2])
    C1550543 (UMLS CUI [1,3])
    Progression Accelerated phase chronic myologenic leukemia | Progression Chronic myelogenous leukemia with crisis of blast cells
    Item
    1. progression to cml-ap or bc
    boolean
    C0449258 (UMLS CUI [1,1])
    C0919870 (UMLS CUI [1,2])
    C0449258 (UMLS CUI [2,1])
    C2861579 (UMLS CUI [2,2])
    Therapeutic procedure Clinical Trial Specified Inappropriate
    Item
    2. patient whose treatment assigned in camn107ecn02 is not appropriate any longer, per investigator's assessment.
    boolean
    C0087111 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    C0205369 (UMLS CUI [1,3])
    C1548788 (UMLS CUI [1,4])
    Treatment Compliance Lacking | Unreliable behavior | Uncooperative behavior
    Item
    3. history of non-compliance to medical regimens, or patients who are considered potentially unreliable and/or not cooperative.
    boolean
    C4319828 (UMLS CUI [1,1])
    C0332268 (UMLS CUI [1,2])
    C4061925 (UMLS CUI [2])
    C0424350 (UMLS CUI [3])
    Pregnancy | Childbearing Potential | Exception Childbearing Potential Contraceptive methods
    Item
    4. women who are (a) pregnant and (b) women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and at least 14 days after last dose of study medication. highly effective contraception methods include:
    boolean
    C0032961 (UMLS CUI [1])
    C3831118 (UMLS CUI [2])
    C1705847 (UMLS CUI [3,1])
    C3831118 (UMLS CUI [3,2])
    C0700589 (UMLS CUI [3,3])
    Total abstinence | Periodic abstinence | Rhythm method of contraception | Oral contraception | Temperature method of contraception | Withdrawal - birth control
    Item
    total abstinence (when this is in line with the preferred and usual lifestyle of the subject. periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
    boolean
    C0234008 (UMLS CUI [1])
    C1256761 (UMLS CUI [2])
    C0035513 (UMLS CUI [3])
    C0029151 (UMLS CUI [4])
    C0419534 (UMLS CUI [5])
    C3812880 (UMLS CUI [6])
    Female Sterilization | Bilateral oophorectomy | Hysterectomy | Tubal Ligation
    Item
    female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
    boolean
    C0015787 (UMLS CUI [1])
    C0278321 (UMLS CUI [2])
    C0020699 (UMLS CUI [3])
    C0520483 (UMLS CUI [4])
    Male sterilization | Partner had vasectomy
    Item
    male sterilization (at least 6 months prior to screening). for female subjects on the study the vasectomized male partner should be the sole partner for that subject.
    boolean
    C0024559 (UMLS CUI [1])
    C0420842 (UMLS CUI [2])
    Combination Criteria
    Item
    combination of any two of the following (a+b or a+c, or b+c):
    boolean
    C0205195 (UMLS CUI [1,1])
    C0243161 (UMLS CUI [1,2])
    Oral contraception | Injectable contraception | Contraceptive implant | Hormonal Contraception | Vaginal ring contraceptive method | Transdermal patch as birth control method
    Item
    1. use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.
    boolean
    C0029151 (UMLS CUI [1])
    C1262153 (UMLS CUI [2])
    C1657106 (UMLS CUI [3])
    C2985296 (UMLS CUI [4])
    C4761166 (UMLS CUI [5])
    C2135981 (UMLS CUI [6])
    Placement of intra-uterine device (IUD) | Placement Intrauterine System
    Item
    2. placement of an intrauterine device (iud) or intrauterine system (ius)
    boolean
    C3514961 (UMLS CUI [1])
    C1533810 (UMLS CUI [2,1])
    C4293370 (UMLS CUI [2,2])
    Contraception, Barrier | Female Condoms | Diaphragm/cervical cap | Spermicidal foam/jelly/cream/film/suppository | Oral contraception
    Item
    3. barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository in case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
    boolean
    C0004764 (UMLS CUI [1])
    C0221829 (UMLS CUI [2])
    C3840973 (UMLS CUI [3])
    C3843415 (UMLS CUI [4])
    C0029151 (UMLS CUI [5])
    Postmenopausal state | Childbearing Potential Absent | Amenorrhea | Bilateral oophorectomy | Hysterectomy | Tubal Ligation
    Item
    women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
    boolean
    C0232970 (UMLS CUI [1])
    C3831118 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    C0002453 (UMLS CUI [3])
    C0278321 (UMLS CUI [4])
    C0020699 (UMLS CUI [5])
    C0520483 (UMLS CUI [6])
    Volver a la parte superior de la página 

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