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])
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])