ID

26239

Beschrijving

Study of BMS-354825 (Dasatinib) in Patients With Chronic Myeloid Leukemia Who Are Either Resistant or Intolerant to Imatinib; ODM derived from: https://clinicaltrials.gov/show/NCT00101660

Link

https://clinicaltrials.gov/show/NCT00101660

Trefwoorden

Versies (1)
  1. 13-10-17 13-10-17 -
Houder van rechten

see clinicaltrials.gov

Geüploaded op

13 oktober 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Chronic Myeloid Leukemia NCT00101660

Engels

Eligibility Chronic Myeloid Leukemia NCT00101660

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age of 18 years and older.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
chronic myeloid leukemia (cml)
Beschrijving

Myeloid Leukemia, Chronic

Datatype

boolean

Alias
UMLS CUI [1]
C0023473
previous treatment with imatinib at a dose of >600 mg/day and the development of progressive disease while receiving imatinib at that dose, or
Beschrijving

Previous treatment with imatinib and the development of progressive disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C2114510
UMLS CUI [1,2]
C0935989
UMLS CUI [2,1]
C1335499
UMLS CUI [2,2]
C0935989
cml with resistance to imatinib at a dose less than or equal to 600 mg/day with genetic mutation in the bcr-abl gene that is associated with a high level of resistance to imatinib, or
Beschrijving

Resistance to imatinib caused of bcr-abl gene mutation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013203
UMLS CUI [1,2]
C1835417
UMLS CUI [1,3]
C0935989
intolerance to imatinib at any dose
Beschrijving

Intolerance to imatinib

Datatype

boolean

Alias
UMLS CUI [1,1]
C0277585
UMLS CUI [1,2]
C0935989
adequate organ function
Beschrijving

Adequate organ function

Datatype

boolean

Alias
UMLS CUI [1]
C0678852
women who are able to bear children must have a negative serum or urine pregnancy test. adequate methods of contraception must be used throughout the study to avoid pregnancy for the entire interval of at least 1 month before and 3 months after completion of the study medication.
Beschrijving

Negative pregnancy test and using of adequate contraception methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C0427780
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
woman who are pregnant or breastfeeding
Beschrijving

Pregnancy or breast-feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
men whose sexual partners are women who are of childbearing potential, and who are unwilling or unable to use an acceptable method to avoid pregnancy of his partner for the entire study period as outlined above
Beschrijving

Sexual partners are women with childbearing potential, who are unwilling/unable to use contraception methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C0036911
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0700589
previous diagnosis of accelerated phase or blast crisis cml.
Beschrijving

Medical history of accelerated phase or blast crisis cml

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0023472
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0919644
participants who are eligible and willing to undergo transplantation during the screening period
Beschrijving

Eligible and willing to undergo transplantation

Datatype

boolean

Alias
UMLS CUI [1,1]
C1504389
UMLS CUI [1,2]
C0085732
uncontrolled or significant cardiovascular disease
Beschrijving

Uncontrolled or significant cardiovascular disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0750502
use of imatinib within 7 days.
Beschrijving

Concomitant medication with imatinib within 7 days

Datatype

boolean

Alias
UMLS CUI [1,1]
C2826666
UMLS CUI [1,2]
C0935989
UMLS CUI [1,3]
C3843296
use of interferon or cytarabine within 14 days
Beschrijving

Concomitant medication with interferon or cytarabine within 14 days

Datatype

boolean

Alias
UMLS CUI [1,1]
C2826666
UMLS CUI [1,2]
C0021747
UMLS CUI [1,3]
C4288440
UMLS CUI [2,1]
C2826666
UMLS CUI [2,2]
C0010711
UMLS CUI [2,3]
C4288440
use of a targeted small-molecule anticancer agent within 14 days
Beschrijving

Concomitant medication with anticancer agents within 14 days

Datatype

boolean

Alias
UMLS CUI [1,1]
C2826666
UMLS CUI [1,2]
C0003392
UMLS CUI [1,3]
C4288440
use of certain medication that carry a known side effect risk of torsade de pointes- certain medications that irreversibly inhibit platelet function or anticoagulants
Beschrijving

Concomitant Medication that carry a side effect risk of torsade de pointes, inhibit platelet function or anticoagulants

Datatype

boolean

Alias
UMLS CUI [1,1]
C2826666
UMLS CUI [1,2]
C0879626
UMLS CUI [1,3]
C0040479
UMLS CUI [2,1]
C2826666
UMLS CUI [2,2]
C3463820
UMLS CUI [2,3]
C1254881
UMLS CUI [3,1]
C2826666
UMLS CUI [3,2]
C3463820
UMLS CUI [3,3]
C0003280
prior therapy with dasatinib.
Beschrijving

Prior therapy with dasatinib

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1455147
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Similar models

Eligibility Chronic Myeloid Leukemia NCT00101660

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age of 18 years and older.
boolean
C0001779 (UMLS CUI [1])
Myeloid Leukemia, Chronic
Item
chronic myeloid leukemia (cml)
boolean
C0023473 (UMLS CUI [1])
Previous treatment with imatinib and the development of progressive disease
Item
previous treatment with imatinib at a dose of >600 mg/day and the development of progressive disease while receiving imatinib at that dose, or
boolean
C2114510 (UMLS CUI [1,1])
C0935989 (UMLS CUI [1,2])
C1335499 (UMLS CUI [2,1])
C0935989 (UMLS CUI [2,2])
Resistance to imatinib caused of bcr-abl gene mutation
Item
cml with resistance to imatinib at a dose less than or equal to 600 mg/day with genetic mutation in the bcr-abl gene that is associated with a high level of resistance to imatinib, or
boolean
C0013203 (UMLS CUI [1,1])
C1835417 (UMLS CUI [1,2])
C0935989 (UMLS CUI [1,3])
Intolerance to imatinib
Item
intolerance to imatinib at any dose
boolean
C0277585 (UMLS CUI [1,1])
C0935989 (UMLS CUI [1,2])
Adequate organ function
Item
adequate organ function
boolean
C0678852 (UMLS CUI [1])
Negative pregnancy test and using of adequate contraception methods
Item
women who are able to bear children must have a negative serum or urine pregnancy test. adequate methods of contraception must be used throughout the study to avoid pregnancy for the entire interval of at least 1 month before and 3 months after completion of the study medication.
boolean
C0427780 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy or breast-feeding
Item
woman who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Sexual partners are women with childbearing potential, who are unwilling/unable to use contraception methods
Item
men whose sexual partners are women who are of childbearing potential, and who are unwilling or unable to use an acceptable method to avoid pregnancy of his partner for the entire study period as outlined above
boolean
C0036911 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Medical history of accelerated phase or blast crisis cml
Item
previous diagnosis of accelerated phase or blast crisis cml.
boolean
C0262926 (UMLS CUI [1,1])
C0023472 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0919644 (UMLS CUI [2,2])
Eligible and willing to undergo transplantation
Item
participants who are eligible and willing to undergo transplantation during the screening period
boolean
C1504389 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
Uncontrolled or significant cardiovascular disease
Item
uncontrolled or significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
Concomitant medication with imatinib within 7 days
Item
use of imatinib within 7 days.
boolean
C2826666 (UMLS CUI [1,1])
C0935989 (UMLS CUI [1,2])
C3843296 (UMLS CUI [1,3])
Concomitant medication with interferon or cytarabine within 14 days
Item
use of interferon or cytarabine within 14 days
boolean
C2826666 (UMLS CUI [1,1])
C0021747 (UMLS CUI [1,2])
C4288440 (UMLS CUI [1,3])
C2826666 (UMLS CUI [2,1])
C0010711 (UMLS CUI [2,2])
C4288440 (UMLS CUI [2,3])
Concomitant medication with anticancer agents within 14 days
Item
use of a targeted small-molecule anticancer agent within 14 days
boolean
C2826666 (UMLS CUI [1,1])
C0003392 (UMLS CUI [1,2])
C4288440 (UMLS CUI [1,3])
Concomitant Medication that carry a side effect risk of torsade de pointes, inhibit platelet function or anticoagulants
Item
use of certain medication that carry a known side effect risk of torsade de pointes- certain medications that irreversibly inhibit platelet function or anticoagulants
boolean
C2826666 (UMLS CUI [1,1])
C0879626 (UMLS CUI [1,2])
C0040479 (UMLS CUI [1,3])
C2826666 (UMLS CUI [2,1])
C3463820 (UMLS CUI [2,2])
C1254881 (UMLS CUI [2,3])
C2826666 (UMLS CUI [3,1])
C3463820 (UMLS CUI [3,2])
C0003280 (UMLS CUI [3,3])
Prior therapy with dasatinib
Item
prior therapy with dasatinib.
boolean
C1514463 (UMLS CUI [1,1])
C1455147 (UMLS CUI [1,2])
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