Chronic-Phase Myeloid Leukemia Disease length Molecular Diagnosis
Item
1. molecular diagnosis of cp cml of ≤ 6 months (from initial diagnosis).
boolean
C0023474 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C1513388 (UMLS CUI [1,3])
Liver function | Renal function | Pancreatic function
Item
2. adequate hepatic, renal and pancreatic function.
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232786 (UMLS CUI [3])
Age
Item
3. age ≥ 18 years.
boolean
C0001779 (UMLS CUI [1])
Prior Therapy CML | Protein-tyrosine kinase inhibitor | Exception hydroxyurea | Exception anagrelide
Item
1. any prior medical treatment for cml, including tyrosine kinase inhibitors (tkis), with the exception of hydroxyurea and/or anagrelide treatment, which are permitted for up to 6 months prior to study entry (signature of icf) if suitably approved for use in the subject's region.
boolean
C1514463 (UMLS CUI [1,1])
C0023473 (UMLS CUI [1,2])
C1268567 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0020402 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0051809 (UMLS CUI [4,2])
Central Nervous System Involvement | Leukemia Leptomeningeal
Item
2. any past or current central nervous system (cns) involvement, including leptomeningeal leukemia.
boolean
C4050309 (UMLS CUI [1])
C0023418 (UMLS CUI [2,1])
C0521401 (UMLS CUI [2,2])
Disease Extramedullary
Item
3. extramedullary disease only.
boolean
C0012634 (UMLS CUI [1,1])
C1517060 (UMLS CUI [1,2])
Major surgery | Therapeutic radiology procedure
Item
4. major surgery or radiotherapy within 14 days of randomization.
boolean
C0679637 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Heart Disease Clinical Significance | Heart Disease Uncontrolled
Item
5. history of clinically significant or uncontrolled cardiac disease.
boolean
C0018799 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
HIV Seropositivity | Hepatitis B | Hepatitis B, Chronic | Hepatitis B surface antigen positive | Hepatitis C | Liver Cirrhosis | Decompensated liver disease
Item
6. known seropositivity to human immunodeficiency virus (hiv), current acute or chronic hepatitis b (hepatitis b surface-antigen positive), hepatitis c, cirrhosis or evidence of decompensated liver disease. patients with resolved hepatitis b can be included.
boolean
C0019699 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0524909 (UMLS CUI [3])
C0149709 (UMLS CUI [4])
C0019196 (UMLS CUI [5])
C0023890 (UMLS CUI [6])
C4075847 (UMLS CUI [7])
Gastrointestinal Disease | Crohn Disease | Ulcerative Colitis | Total excision of stomach | Subtotal gastrectomy
Item
7. recent or ongoing clinically significant gi disorder, e.g. crohn's disease, ulcerative colitis, or prior total or partial gastrectomy.
boolean
C0017178 (UMLS CUI [1])
C0010346 (UMLS CUI [2])
C0009324 (UMLS CUI [3])
C0161899 (UMLS CUI [4])
C0030600 (UMLS CUI [5])
Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Malignant Neoplasm TNM clinical staging Treated | Exception Malignant Neoplasm TNM clinical staging In complete remission
Item
8. history of another malignancy within 5 years with the exception of basal cell carcinoma or cervical carcinoma in situ or stage 1 or 2 cancer that is considered adequately treated and currently in complete remission for at least l2 months.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
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])
C3258246 (UMLS CUI [5,3])
C0677874 (UMLS CUI [5,4])
Study Subject Participation Status | Clinical Trial | Investigational New Drugs | Interventional procedure Inconsistent Clinical Trial Current
Item
9. current, or recent (within 30 days, or 5 half-lives of investigational product) participation in other clinical trials of investigational agents and/or containing interventional procedures deemed contrary to the objectives and conduct of this trial.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
C0184661 (UMLS CUI [4,1])
C0442809 (UMLS CUI [4,2])
C0008976 (UMLS CUI [4,3])
C0521116 (UMLS CUI [4,4])