ID

28077

Description

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

Link

https://clinicaltrials.gov/show/NCT00866736

Keywords

Versions (1)
  1. 12/15/17 12/15/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 15, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Myeloid Leukemia NCT00866736

English

Eligibility Chronic Myeloid Leukemia NCT00866736

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed written informed consent
Description

Informed Consent

Data type

boolean

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

Leukemia, Myeloid, Chronic-Phase

Data type

boolean

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

Imatinib Resistance | Intolerance to imatinib

Data type

boolean

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

Subject Presenting

Data type

boolean

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

ECOG performance status

Data type

boolean

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

Liver function

Data type

boolean

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

Renal function

Data type

boolean

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

Pulmonary function

Data type

boolean

Alias
UMLS CUI [1]
C0231921
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
concurrent malignancy other than cml
Description

Cancer Other

Data type

boolean

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

Pregnancy | Breast Feeding

Data type

boolean

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

Pleural effusion

Data type

boolean

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

Cardiovascular Disease Uncontrolled | Cardiovascular Disease

Data type

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.
Description

Disease Uncontrolled Investigational Therapy Impaired

Data type

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
Description

dasatinib

Data type

boolean

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

BCR-ABL T315I mutation | Other Coding

Data type

boolean

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

Eligibility Chronic Myeloid Leukemia NCT00866736

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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