ID

28078

Description

Investigating Intracellular and Plasma Imatinib Levels in Chronic Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00947830

Link

https://clinicaltrials.gov/show/NCT00947830

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 NCT00947830

English

Eligibility Chronic Myeloid Leukemia NCT00947830

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have a diagnosis of chronic myeloid leukemia in chronic phase (as defined in appendix a) within four weeks of study registration based on bone marrow aspirate and peripheral blood counts. - patients must have confirmation of the philadelphia chromosome or variants by cytogenetics, or fish, or positive test for bcr-abl by pcr. patients with additional chromosomal abnormalities in addition to the philadelphia chromosome are eligible.
Description

Myeloid Leukemia Chronic-Phase Bone marrow aspirate examination | Myeloid Leukemia Chronic-Phase Blood Count Peripheral blood | Philadelphia chromosome positive Cytogenetic Analysis | Philadelphia chromosome positive FISH | Philadelphia Chromosome Variant Positive Cytogenetic Analysis | Philadelphia Chromosome Variant Positive FISH | BCR-ABL Positive Polymerase Chain Reaction | Chromosome Aberrations Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C0023474
UMLS CUI [1,2]
C1271729
UMLS CUI [2,1]
C0023474
UMLS CUI [2,2]
C0005771
UMLS CUI [2,3]
C0229664
UMLS CUI [3,1]
C0856536
UMLS CUI [3,2]
C0752095
UMLS CUI [4,1]
C0856536
UMLS CUI [4,2]
C0162789
UMLS CUI [5,1]
C0031526
UMLS CUI [5,2]
C0205419
UMLS CUI [5,3]
C1514241
UMLS CUI [5,4]
C0752095
UMLS CUI [6,1]
C0031526
UMLS CUI [6,2]
C0205419
UMLS CUI [6,3]
C1514241
UMLS CUI [6,4]
C0162789
UMLS CUI [7,1]
C1835417
UMLS CUI [7,2]
C1514241
UMLS CUI [7,3]
C0032520
UMLS CUI [8,1]
C0008625
UMLS CUI [8,2]
C1524062
age >18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status <2. (appendix b)
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
patients must have normal organ function as defined below:
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
total bilirubin < 1.5 x institutional upper limit of normal (uln)
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
ast and/or alt < 2.5 x institutional upper limit of normal (uln)
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
eligibility of patients receiving any medications or substances known to affect or determined following review of their case by the principal investigator.
Description

Pharmaceutical Preparations Affecting Review of Case

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0699752
UMLS CUI [1,4]
C0868928
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients may not be receiving any other investigational agents.
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
patients may not have received prior treatment with imatinib.
Description

imatinib

Data type

boolean

Alias
UMLS CUI [1]
C0935989
uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Description

Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Protocol Compliance Limited | Social situation Protocol Compliance Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0525058
UMLS CUI [6,3]
C0439801
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C0525058
UMLS CUI [7,3]
C0439801
pregnant or nursing women are excluded from this study because imatinib has potential teratogenic effects and excretion in breast milk is unknown.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
no prior malignancies except for: adequately treated non-melanoma skin cancer, cervical carcinoma-in-situ, adequately treated stage i or ii cancer from which patient is in complete remission, or any other cancer from which patient has been disease free for 5 years.
Description

Malignant Neoplasms | Exception Skin carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Malignant Neoplasm TNM clinical staging Treated | Exception Malignant Neoplasm In complete remission | Exception Cancer Other Disease Free of

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0006826
UMLS CUI [4,3]
C3258246
UMLS CUI [4,4]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0006826
UMLS CUI [5,3]
C0677874
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C1707251
UMLS CUI [6,3]
C0012634
UMLS CUI [6,4]
C0332296
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Similar models

Eligibility Chronic Myeloid Leukemia NCT00947830

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Myeloid Leukemia Chronic-Phase Bone marrow aspirate examination | Myeloid Leukemia Chronic-Phase Blood Count Peripheral blood | Philadelphia chromosome positive Cytogenetic Analysis | Philadelphia chromosome positive FISH | Philadelphia Chromosome Variant Positive Cytogenetic Analysis | Philadelphia Chromosome Variant Positive FISH | BCR-ABL Positive Polymerase Chain Reaction | Chromosome Aberrations Additional
Item
patients must have a diagnosis of chronic myeloid leukemia in chronic phase (as defined in appendix a) within four weeks of study registration based on bone marrow aspirate and peripheral blood counts. - patients must have confirmation of the philadelphia chromosome or variants by cytogenetics, or fish, or positive test for bcr-abl by pcr. patients with additional chromosomal abnormalities in addition to the philadelphia chromosome are eligible.
boolean
C0023474 (UMLS CUI [1,1])
C1271729 (UMLS CUI [1,2])
C0023474 (UMLS CUI [2,1])
C0005771 (UMLS CUI [2,2])
C0229664 (UMLS CUI [2,3])
C0856536 (UMLS CUI [3,1])
C0752095 (UMLS CUI [3,2])
C0856536 (UMLS CUI [4,1])
C0162789 (UMLS CUI [4,2])
C0031526 (UMLS CUI [5,1])
C0205419 (UMLS CUI [5,2])
C1514241 (UMLS CUI [5,3])
C0752095 (UMLS CUI [5,4])
C0031526 (UMLS CUI [6,1])
C0205419 (UMLS CUI [6,2])
C1514241 (UMLS CUI [6,3])
C0162789 (UMLS CUI [6,4])
C1835417 (UMLS CUI [7,1])
C1514241 (UMLS CUI [7,2])
C0032520 (UMLS CUI [7,3])
C0008625 (UMLS CUI [8,1])
C1524062 (UMLS CUI [8,2])
Age
Item
age >18 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status <2. (appendix b)
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
patients must have normal organ function as defined below:
boolean
C0678852 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin < 1.5 x institutional upper limit of normal (uln)
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast and/or alt < 2.5 x institutional upper limit of normal (uln)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Pharmaceutical Preparations Affecting Review of Case
Item
eligibility of patients receiving any medications or substances known to affect or determined following review of their case by the principal investigator.
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0699752 (UMLS CUI [1,3])
C0868928 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs
Item
patients may not be receiving any other investigational agents.
boolean
C0013230 (UMLS CUI [1])
imatinib
Item
patients may not have received prior treatment with imatinib.
boolean
C0935989 (UMLS CUI [1])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Protocol Compliance Limited | Social situation Protocol Compliance Limited
Item
uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0525058 (UMLS CUI [6,2])
C0439801 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0525058 (UMLS CUI [7,2])
C0439801 (UMLS CUI [7,3])
Pregnancy | Breast Feeding
Item
pregnant or nursing women are excluded from this study because imatinib has potential teratogenic effects and excretion in breast milk is unknown.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Malignant Neoplasms | Exception Skin carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Malignant Neoplasm TNM clinical staging Treated | Exception Malignant Neoplasm In complete remission | Exception Cancer Other Disease Free of
Item
no prior malignancies except for: adequately treated non-melanoma skin cancer, cervical carcinoma-in-situ, adequately treated stage i or ii cancer from which patient is in complete remission, or any other cancer from which patient has been disease free for 5 years.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0006826 (UMLS CUI [4,2])
C3258246 (UMLS CUI [4,3])
C1522326 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C0006826 (UMLS CUI [5,2])
C0677874 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C1707251 (UMLS CUI [6,2])
C0012634 (UMLS CUI [6,3])
C0332296 (UMLS CUI [6,4])
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