ID

28077

Beskrivning

A Study of Dasatinib in Patients With Imatinib Resistant or Intolerant Chronic Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00866736

Länk

https://clinicaltrials.gov/show/NCT00866736

Nyckelord

  1. 2017-12-15 2017-12-15 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

15 december 2017

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Chronic Myeloid Leukemia NCT00866736

Eligibility Chronic Myeloid Leukemia NCT00866736

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
subjects with chronic phase chronic myeloid leukemia (cml)
Beskrivning

Leukemia, Myeloid, Chronic-Phase

Datatyp

boolean

Alias
UMLS CUI [1]
C0023474
subjects resistant/intolerant to imatinib
Beskrivning

Imatinib Resistance | Intolerance to imatinib

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0935989
UMLS CUI [1,2]
C1514892
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0935989
subjects presenting:
Beskrivning

Subject Presenting

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0449450
1. ecog performance status (ps) score 0-2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
2. adequate hepatic function
Beskrivning

Liver function

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
3. adequate renal function
Beskrivning

Renal function

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
4. adequate lung function
Beskrivning

Pulmonary function

Datatyp

boolean

Alias
UMLS CUI [1]
C0231921
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
concurrent malignancy other than cml
Beskrivning

Cancer Other

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
women who are pregnant or breastfeeding
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
concurrent pleural effusion
Beskrivning

Pleural effusion

Datatyp

boolean

Alias
UMLS CUI [1]
C0032227
uncontrolled or significant cardiovascular disease
Beskrivning

Cardiovascular Disease Uncontrolled | Cardiovascular Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0007222
a serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy.
Beskrivning

Disease Uncontrolled Investigational Therapy Impaired

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0949266
UMLS CUI [1,4]
C0221099
prior therapy with dasatinib
Beskrivning

dasatinib

Datatyp

boolean

Alias
UMLS CUI [1]
C1455147
subjects with t315i and/or f317l bcr-abl point mutations
Beskrivning

BCR-ABL T315I mutation | Other Coding

Datatyp

boolean

Alias
UMLS CUI [1]
C3888919
UMLS CUI [2]
C3846158

Similar models

Eligibility Chronic Myeloid Leukemia NCT00866736

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Leukemia, Myeloid, Chronic-Phase
Item
subjects with chronic phase chronic myeloid leukemia (cml)
boolean
C0023474 (UMLS CUI [1])
Imatinib Resistance | Intolerance to imatinib
Item
subjects resistant/intolerant to imatinib
boolean
C0935989 (UMLS CUI [1,1])
C1514892 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0935989 (UMLS CUI [2,2])
Subject Presenting
Item
subjects presenting:
boolean
C0681850 (UMLS CUI [1,1])
C0449450 (UMLS CUI [1,2])
ECOG performance status
Item
1. ecog performance status (ps) score 0-2
boolean
C1520224 (UMLS CUI [1])
Liver function
Item
2. adequate hepatic function
boolean
C0232741 (UMLS CUI [1])
Renal function
Item
3. adequate renal function
boolean
C0232804 (UMLS CUI [1])
Pulmonary function
Item
4. adequate lung function
boolean
C0231921 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer Other
Item
concurrent malignancy other than cml
boolean
C1707251 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
women who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Pleural effusion
Item
concurrent pleural effusion
boolean
C0032227 (UMLS CUI [1])
Cardiovascular Disease Uncontrolled | Cardiovascular Disease
Item
uncontrolled or significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2])
Disease Uncontrolled Investigational Therapy Impaired
Item
a serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy.
boolean
C0012634 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0949266 (UMLS CUI [1,3])
C0221099 (UMLS CUI [1,4])
dasatinib
Item
prior therapy with dasatinib
boolean
C1455147 (UMLS CUI [1])
BCR-ABL T315I mutation | Other Coding
Item
subjects with t315i and/or f317l bcr-abl point mutations
boolean
C3888919 (UMLS CUI [1])
C3846158 (UMLS CUI [2])

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