Myeloid Leukemia, Chronic | Criteria Fulfill
Item
diagnosis of chronic myelogenous leukemia (cml) meeting the following criteria:
boolean
C0023473 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Disease Philadelphia chromosome positive
Item
philadelphia chromosome positive disease
boolean
C0012634 (UMLS CUI [1,1])
C0856536 (UMLS CUI [1,2])
b3a2 Breakpoint Mutation
Item
b3a2 breakpoint mutation
boolean
C1955181 (UMLS CUI [1,1])
C2717920 (UMLS CUI [1,2])
C0026882 (UMLS CUI [1,3])
Imatinib mesylate
Item
prior treatment with conventional imatinib mesylate for ≥ 18 months required
boolean
C0939537 (UMLS CUI [1])
Cytogenetic Complete Response Examined Quantity
Item
complete cytogenetic response documented on ≥ 2 different examinations
boolean
C4050364 (UMLS CUI [1,1])
C0332128 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Residual disease Persistence Molecular Detectable | BCR-ABL Transcript Level
Item
persistence of molecularly detectable residual disease (any level of bcr-abl transcript)
boolean
C0543478 (UMLS CUI [1,1])
C0546816 (UMLS CUI [1,2])
C1521991 (UMLS CUI [1,3])
C3830527 (UMLS CUI [1,4])
C1835417 (UMLS CUI [2,1])
C1519595 (UMLS CUI [2,2])
C0441889 (UMLS CUI [2,3])
Imatinib mesylate Dose Same
Item
patients continue to receive imatinib mesylate at the same dose (conventional treatment) during study treatment
boolean
C0939537 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0445247 (UMLS CUI [1,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
WHO performance status scale
Item
who performance status 0-1
boolean
C1298650 (UMLS CUI [1])
Serum total bilirubin measurement
Item
bilirubin ≤ 2 times upper limit of normal (uln)
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast and alt ≤ 2.5 times uln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine measurement, serum
Item
creatinine ≤ 1.5 times uln
boolean
C0201976 (UMLS CUI [1])
Pregnancy Exclusion | Breast Feeding Exclusion
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Pregnancy test negative
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Fertility Contraceptive methods
Item
fertile patients must use effective contraception
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Communicable Diseases Severe Exclude Completion of clinical trial | Illness Serious Excludes Completion of clinical trial
Item
no severe active infection or other serious medical illness that would preclude study completion
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C2732579 (UMLS CUI [1,4])
C0221423 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C2732579 (UMLS CUI [2,4])
Immunologic Deficiency Syndromes Exclusion
Item
no known immunodeficiency
boolean
C0021051 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Autoimmune Diseases Exclusion
Item
no autoimmune disorders
boolean
C0004364 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Therapeutic immunosuppression Exclusion | Immunosuppressive Agents Systemic Exclusion
Item
no concurrent immunosuppression or systemic immunosuppressive medication
boolean
C0021079 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0021081 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
Imatinib mesylate Dose Escalation Exclusion
Item
no concurrent dose escalation of imatinib mesylate
boolean
C0939537 (UMLS CUI [1,1])
C3816728 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
Investigational New Drugs Exclusion
Item
no other concurrent investigational products
boolean
C0013230 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])