Age | Leukemia, Myeloid, Chronic-Phase First | Cytogenetic Complete Response failed | Molecular Complete Response failed | Disease Progression Post Imatinib | Intolerance to Tyrosine kinase inhibitor
Item
1. patients with age <= 75 years with cml in first chronic phase, which has failed to achieve a cytogenetic or molecular complete remission or has progressed after imatinib treatment. criteria for failure are the international consensus criteria (appendix h). patients intolerant to tyrosine kinase inhibitor therapy are also eligible.
boolean
C0001779 (UMLS CUI [1])
C0023474 (UMLS CUI [2,1])
C0205435 (UMLS CUI [2,2])
C4050364 (UMLS CUI [3,1])
C0231175 (UMLS CUI [3,2])
C4050308 (UMLS CUI [4,1])
C0231175 (UMLS CUI [4,2])
C0242656 (UMLS CUI [5,1])
C0687676 (UMLS CUI [5,2])
C0935989 (UMLS CUI [5,3])
C1744706 (UMLS CUI [6,1])
C1268567 (UMLS CUI [6,2])
Age | Leukemia, Myeloid, Accelerated Phase | Blast Phase Blasts Percentage Blood | Blast Phase Blasts Percentage Bone Marrow
Item
2. patients with age <= 75 with cml in accelerated phase or blast crisis that have <= 15% blasts in the blood and bone marrow at study entry.
boolean
C0001779 (UMLS CUI [1])
C0023472 (UMLS CUI [2])
C0005699 (UMLS CUI [3,1])
C0368761 (UMLS CUI [3,2])
C0439165 (UMLS CUI [3,3])
C0005767 (UMLS CUI [3,4])
C0005699 (UMLS CUI [4,1])
C0368761 (UMLS CUI [4,2])
C0439165 (UMLS CUI [4,3])
C0005953 (UMLS CUI [4,4])
Donor | Relative HLA-A Antigen Match | Relative HLA-B Antigen Match | Relative HLA-C Antigen Match | Relative HLA-DRB1 antigen Match | Relative Antigen Quantity Mismatch | Unrelated HLA-A Antigen Match | Unrelated HLA-B Antigen Match | Unrelated HLA-C Antigen Match | Unrelated HLA-DRB1 antigen Match | Unrelated Antigen Quantity Mismatch
Item
3. donor: hla-compatible related (hla-a, -b, -drb1 matched or with one-antigen mismatch) or hla-compatible unrelated (hla-a, -b, -c and -drb1 matched or with one-antigen mismatch).
boolean
C0013018 (UMLS CUI [1])
C0080103 (UMLS CUI [2,1])
C0019728 (UMLS CUI [2,2])
C1708943 (UMLS CUI [2,3])
C0080103 (UMLS CUI [3,1])
C0019737 (UMLS CUI [3,2])
C1708943 (UMLS CUI [3,3])
C0080103 (UMLS CUI [4,1])
C0019751 (UMLS CUI [4,2])
C1708943 (UMLS CUI [4,3])
C0080103 (UMLS CUI [5,1])
C0122040 (UMLS CUI [5,2])
C1708943 (UMLS CUI [5,3])
C0080103 (UMLS CUI [6,1])
C0003320 (UMLS CUI [6,2])
C1265611 (UMLS CUI [6,3])
C1881865 (UMLS CUI [6,4])
C0445356 (UMLS CUI [7,1])
C0019728 (UMLS CUI [7,2])
C1708943 (UMLS CUI [7,3])
C0445356 (UMLS CUI [8,1])
C0019737 (UMLS CUI [8,2])
C1708943 (UMLS CUI [8,3])
C0445356 (UMLS CUI [9,1])
C0019751 (UMLS CUI [9,2])
C1708943 (UMLS CUI [9,3])
C0445356 (UMLS CUI [10,1])
C0122040 (UMLS CUI [10,2])
C1708943 (UMLS CUI [10,3])
C0445356 (UMLS CUI [11,1])
C0003320 (UMLS CUI [11,2])
C1265611 (UMLS CUI [11,3])
C1881865 (UMLS CUI [11,4])
Age
Item
4. age 18 to 75 years.
boolean
C0001779 (UMLS CUI [1])
Zubrod Performance Status
Item
5. zubrod performance status <= 2.
boolean
C3714786 (UMLS CUI [1])
Left ventricular ejection fraction
Item
6. left ventricular ejection fraction => 40%.
boolean
C0428772 (UMLS CUI [1])
Pulmonary function tests | FEV1 | Forced Vital Capacity | Hemoglobin Corrected Diffusion Capacity of the Lung for Carbon Monoxide
Item
7. pulmonary function test within the following parameters: forced expiratory volume at one second (fev1), forced vital capacity (fvc) and diffusing capacity of lung for carbon monoxide (dlco) => 50% of expected, corrected for hemoglobin.
boolean
C0024119 (UMLS CUI [1])
C0849974 (UMLS CUI [2])
C3714541 (UMLS CUI [3])
C4054790 (UMLS CUI [4])
Creatinine measurement, serum | Creatinine clearance measurement
Item
8. serum creatinine < 1.5 mg/dl or creatinine clearance greater or equal than 40 cc/min.
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Serum direct bilirubin measurement | Exception Gilbert syndrome
Item
9. serum direct bilirubin < 1.5 mg/dl (unless gilbert's syndrome)
boolean
C1883011 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0017551 (UMLS CUI [2,2])
Alanine aminotransferase measurement | Exception Relationship Malignant Neoplasms
Item
10. serum glutamate pyruvate transaminase (sgpt) <= 200 iu/l unless related to patient's malignancy.
boolean
C0201836 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0006826 (UMLS CUI [2,3])
Tyrosine kinase inhibitor | Interferon | Therapies, Investigational
Item
11. patients treated with any tyrosine kinase inhibitor, interferon or any experimental therapy are eligible.
boolean
C1268567 (UMLS CUI [1])
C3652465 (UMLS CUI [2])
C0949266 (UMLS CUI [3])
Age | Leukemia, Myeloid, Chronic-Phase second
Item
12. patients with age <75 years with cml in second or subsequent chronic phase.
boolean
C0001779 (UMLS CUI [1])
C0023474 (UMLS CUI [2,1])
C0205436 (UMLS CUI [2,2])
Communicable Disease Uncontrolled | Antimicrobial agents Unresponsive to Treatment
Item
1. uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1136254 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
Pleural effusion | Pericardial effusion | Ascites
Item
2. pleural/pericardial effusion or ascites estimated to be >1l.
boolean
C0032227 (UMLS CUI [1])
C0031039 (UMLS CUI [2])
C0003962 (UMLS CUI [3])
HIV Seropositivity
Item
3. hiv-positive.
boolean
C0019699 (UMLS CUI [1])
Breast Feeding | Pregnancy | Childbearing Potential Serum pregnancy test (B-HCG) Positive | Postmenopausal state Absent | Female Sterilization Absent
Item
4. breast feeding or pregnancy. pregnancy means a positive beta human chorionic gonadotropin (hcg) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0430060 (UMLS CUI [3,2])
C1514241 (UMLS CUI [3,3])
C0232970 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0015787 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Hypersensitivity Azacitidine | Mannitol allergy | Hypersensitivity Suspected Azacitidine | Mannitol allergy Suspected
Item
5. known or suspected hypersensitivity to azacitidine or mannitol.
boolean
C0020517 (UMLS CUI [1,1])
C0004475 (UMLS CUI [1,2])
C0571922 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0004475 (UMLS CUI [3,3])
C0571922 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
Malignant neoplasm of liver Advanced
Item
6. patients with advanced malignant hepatic tumors.
boolean
C0345904 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])