Age | Chronic Myeloid Leukemia Philadelphia negative Cytogenetic Analysis | BCR/ABL positive Chronic myelogenous leukemia Cytogenetic Analysis | Fluorescent in Situ Hybridization | Polymerase Chain Reaction
Item
1. patients >/= 18 years with philadelphia chromosome (ph)- or bcr/ablpositive cml (as determined by cytogenetics, fish, or pcr).
boolean
C0001779 (UMLS CUI [1])
C0023473 (UMLS CUI [2,1])
C0457341 (UMLS CUI [2,2])
C0752095 (UMLS CUI [2,3])
C1292771 (UMLS CUI [3,1])
C0752095 (UMLS CUI [3,2])
C0162789 (UMLS CUI [4])
C0032520 (UMLS CUI [5])
imatinib | Dose Increased Absent
Item
2. patients must have received imatinib therapy for at least 18 months and not have increased their dose of imatinib in the last 6 months.
boolean
C0935989 (UMLS CUI [1])
C1707810 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Cytogenetic Complete Response
Item
3. patients must be in complete cytogenetic remission.
boolean
C4050364 (UMLS CUI [1])
bcr-abl Transcript Levels Detectable | Molecular Major Response failed | Transcript Levels Increased | Measurement Quantity
Item
4. patients must have detectable bcr-abl transcript levels meeting at least one of the following criteria: 1) patient has never achieved a major molecular response (i.e., never reached levels <0.05%), and transcript levels have shown in at least two consecutive measures separated by at least 1 month to have increased by any value, or
boolean
C0004891 (UMLS CUI [1,1])
C3481430 (UMLS CUI [1,2])
C0441889 (UMLS CUI [1,3])
C3830527 (UMLS CUI [1,4])
C4049637 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C3481430 (UMLS CUI [3,1])
C0441889 (UMLS CUI [3,2])
C0205217 (UMLS CUI [3,3])
C0242485 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
Molecular Major Response achieved | Transcript Levels Increased | Molecular Major Response lost | Analysis Quantity | bcr-abl Transcript Levels
Item
5. continued from above: 2) achieved a major molecular response that has been lost with an increase in transcript levels by at least 1-log over two consecutive analyses separated by at least 1 month, or 3) bcr-abl transcript levels have reached a plateau defined as a ratio that is not more than 0.25-log (one fourth of a log) lower than the lowest value obtained in the last at least 6 months, with at least 2 values obtained during this period.
boolean
C4049637 (UMLS CUI [1,1])
C1272277 (UMLS CUI [1,2])
C3481430 (UMLS CUI [2,1])
C0441889 (UMLS CUI [2,2])
C0205217 (UMLS CUI [2,3])
C4049637 (UMLS CUI [3,1])
C0745777 (UMLS CUI [3,2])
C0002778 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0004891 (UMLS CUI [5,1])
C3481430 (UMLS CUI [5,2])
C0441889 (UMLS CUI [5,3])
imatinib | Therapy interrupted Absent
Item
6. patients must not have had a continuous interruption of imatinib therapy of greater than 14 days or any interruptions totaling 6 weeks within the 6 months prior to enrollment.
boolean
C0935989 (UMLS CUI [1])
C1710384 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
HLA-A2 Positive | Allele Quantity
Item
7. patients must be hla-a2 positive at one allele
boolean
C0019733 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0002085 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Informed Consent | Compliance behavior
Item
8. patients must give informed consent and sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital.
boolean
C0021430 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
ECOG performance status
Item
9. eastern cooperative oncology group (ecog) performance status </= 2.
boolean
C1520224 (UMLS CUI [1])
Organ function | Serum total bilirubin measurement | Creatinine measurement, serum | Alanine aminotransferase measurement
Item
10. adequate organ function defined as: bilirubin <2 times upper limit of normal (uln), creatinine <1.5 times uln, and serum glutamate pyruvate transaminase (sgpt) <2.5 times uln.
boolean
C0678852 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Childbearing Potential Contraceptive methods
Item
11. women of childbearing potential should practice effective methods of contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Autoimmune Diseases Evidence Clinical
Item
1. patients with a history or clinical evidence of autoimmune disorders
boolean
C0004364 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
Therapeutic immunosuppression | Cyclosporine | FK-506
Item
2. patients receiving immunosuppressive therapy including cyclosporine, or fk506 within 3 months of study entry
boolean
C0021079 (UMLS CUI [1])
C0010592 (UMLS CUI [2])
C0729218 (UMLS CUI [3])
Adrenal Cortex Hormones High dose Chronic | Prednisone | Topical corticosteroids | inhaled steroids
Item
3. chronic use (> 2 weeks) of greater than physiologic doses of corticosteroid agent (dose equivalent to > 10 mg/day of prednisone) within 28 days of the first day of study drug treatment (topical and inhaled corticosteroids are permitted)
boolean
C0001617 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0032952 (UMLS CUI [2])
C0304604 (UMLS CUI [3])
C2065041 (UMLS CUI [4])
Granulocyte-Macrophage Colony-Stimulating Factor | Interferon
Item
4. gm-csf or interferon administration within 1 month of first pr1 injection
boolean
C0079460 (UMLS CUI [1])
C0021747 (UMLS CUI [2])
Investigational New Drugs | Investigational Therapy Adverse effects Patient recovered
Item
5. patients receiving any other investigational agents currently or within the past 4 weeks. patients must have recovered from any adverse effects of investigational therapy.
boolean
C0013230 (UMLS CUI [1])
C0949266 (UMLS CUI [2,1])
C0879626 (UMLS CUI [2,2])
C1115804 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
6. patients who are pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Heart Disease New York Heart Association Classification
Item
7. patients with clinically significant heart disease (new york heart association (nyha) class iii or iv)
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
c-ANCA positive
Item
8. patients with positive canca
boolean
C0238874 (UMLS CUI [1])
HIV Seropositivity | Acquired Immunodeficiency Syndrome
Item
9. history of hiv positivity or aids
boolean
C0019699 (UMLS CUI [1])
C0001175 (UMLS CUI [2])
Chloroma
Item
10. chloroma at time of study screening
boolean
C0152276 (UMLS CUI [1])
Vaccine Therapy Chronic Myeloid Leukemia
Item
11. prior vaccine therapy for chronic myelogenous leukemia (cml)
boolean
C0042209 (UMLS CUI [1,1])
C0023473 (UMLS CUI [1,2])
Hypersensitivity Montanide ISA 51 VG Adjuvant
Item
12. known allergy to montanide isa-51 vg adjuvant
boolean
C0020517 (UMLS CUI [1,1])
C2827521 (UMLS CUI [1,2])
C0001552 (UMLS CUI [1,3])