ID

41113

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02272777

Nyckelord

Versioner (1)
  1. 2020-06-25 2020-06-25 -
Rättsinnehavare

See clinicaltrials.gov

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25 juni 2020

DOI

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Creative Commons BY 4.0
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Eligibility Leukemia NCT02272777

Engelsk

Eligibility Leukemia NCT02272777

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02272777
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Inclusion criteria All Fulfill

Datatyp

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
Beskrivning

Therapeutic procedure Clinical Trial Specified

Datatyp

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
Beskrivning

Patient Receiving Benefit | Therapeutic procedure Clinical Trial Specified

Datatyp

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.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

Exclusion Criteria Any Fulfill

Datatyp

boolean

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

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

Datatyp

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.
Beskrivning

Therapeutic procedure Clinical Trial Specified Inappropriate

Datatyp

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.
Beskrivning

Treatment Compliance Lacking | Unreliable behavior | Uncooperative behavior

Datatyp

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:
Beskrivning

Pregnancy | Childbearing Potential | Exception Childbearing Potential Contraceptive methods

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Female Sterilization | Bilateral oophorectomy | Hysterectomy | Tubal Ligation

Datatyp

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.
Beskrivning

Male sterilization | Partner had vasectomy

Datatyp

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):
Beskrivning

Combination Criteria

Datatyp

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.
Beskrivning

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

Datatyp

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)
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

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
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Similar models

Eligibility Leukemia NCT02272777

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02272777
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
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