Leukemia, Myeloid, Chronic-Phase | Imatinib mesylate Disease Response failed | Imatinib mesylate Cytogenetic Response Lacking | Cytogenetic Response Major Lacking | Cytogenetic Complete Response Lacking | BCR-ABL Fusion Gene abl gene Ratio Increase | Polymerase chain reaction analysis Quantity
Item
1. patients with cml in chronic phase who have failed to achieve or have lost an adequate response to im. for the purpose of this trial this will be defined as a lack of any cytogenetic response after 6 months of therapy or lack of major cytogenetic response after 12 months of therapy with im. patients that have lost their major or complete cytogenetic response will also be eligible. patients who show a sustained increase in breakpoint cluster region gene (bcr)-abelson gene (abl)/abl [bcr-abl/abl] ratio of >/= 1-log confirmed in at least two consecutive polymerase chain reaction (pcr) analyses (at least one month apart from each other) will also be eligible.
boolean
C0023474 (UMLS CUI [1])
C0939537 (UMLS CUI [2,1])
C1704632 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C0939537 (UMLS CUI [3,1])
C4055168 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
C4055168 (UMLS CUI [4,1])
C0205164 (UMLS CUI [4,2])
C0332268 (UMLS CUI [4,3])
C4050364 (UMLS CUI [5,1])
C0332268 (UMLS CUI [5,2])
C1835417 (UMLS CUI [6,1])
C0079413 (UMLS CUI [6,2])
C0456603 (UMLS CUI [6,3])
C0442805 (UMLS CUI [6,4])
C0200931 (UMLS CUI [7,1])
C1265611 (UMLS CUI [7,2])
Molecular Response Stable | Polymerase chain reaction analysis Positive Quantity | Imatinib mesylate Dose Stable | Toxic effect Imatinib mesylate Related | Patients Recovered CTCAE Grades
Item
2. *continued from above: patients with stable molecular response defined as 2 consecutive pcr-positive results (no more than 1/2 log improvement) will also be eligible. patients must be taking stable dose of im for at least 3 months before study enrollment, and recovered from all toxicities related to im, to grade 0-1.
boolean
C4054479 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0200931 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0939537 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0600688 (UMLS CUI [4,1])
C0939537 (UMLS CUI [4,2])
C0439849 (UMLS CUI [4,3])
C0030705 (UMLS CUI [5,1])
C0521108 (UMLS CUI [5,2])
C1516728 (UMLS CUI [5,3])
Decrease Hematologic Complete | Decrease Hematologic Partial | White Blood Cell Count procedure | Platelet Count measurement
Item
3. patients should be in complete or partial hematological remission, including white blood count (wbc) </=20 x 10(9)/l, and platelets </= 600 x 10(9)/l.
boolean
C0547047 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0547047 (UMLS CUI [2,1])
C0205488 (UMLS CUI [2,2])
C0728938 (UMLS CUI [2,3])
C0023508 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
ECOG performance status
Item
4. eastern cooperative oncology group (ecog) scale performance status of 2 or less.
boolean
C1520224 (UMLS CUI [1])
Age
Item
5. age greater than 18 years of age since disease is extremely rare in younger age groups.
boolean
C0001779 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum
Item
6. adequate liver (total bilirubin of less than 2 times and aspartate aminotransferase (ast) or alanine aminotransferase (alt) of less than 2 times upper limits of normal), and renal function (creatinine of less than 2 times upper limit of normal).
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0232804 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
Informed Consent
Item
7. signed informed consent form.
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative
Item
8. negative pregnancy test in women of childbearing age.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Hepatitis B Hematologic Test Negative | Hepatitis C Hematologic Test Negative
Item
9. negative hepatitis b and c screening blood tests.
boolean
C0019163 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C0019196 (UMLS CUI [2,1])
C0018941 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
Comorbidity Serious | Communicable Diseases Requirement Antibiotics Parenteral | Protocol Compliance Limited
Item
1. serious intercurrent medical illnesses or active infections requiring parenteral antibiotics that would interfere with the ability of the patient to carry out the treatment program.
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0003232 (UMLS CUI [2,3])
C1518896 (UMLS CUI [2,4])
C0525058 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
2. female patients who are pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Steroids
Item
3. patients taking steroids, or those anticipated to receive steroids during the trial therapy.
boolean
C0038317 (UMLS CUI [1])
Bone Marrow Transplantation
Item
4. prior bone marrow transplant.
boolean
C0005961 (UMLS CUI [1])
HIV Seropositivity
Item
5. known positivity for human immunodeficiency virus (hiv).
boolean
C0019699 (UMLS CUI [1])