AML Untreated | Exception Prior Therapy | Exception Hydroxyurea | Exception Decitabine | Exception Hematopoietic Growth Factors | Exception Biological treatment | Exception Targeted Therapy
Item
1. previously untreated aml patients, except those who have received prior therapy with hydroxyurea, single agent chemotherapy (e.g. decitabine), hematopoietic growth factors, biological or targeted therapies are allowed.
boolean
C0023467 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0020402 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0049065 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0079490 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C1531518 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C2985566 (UMLS CUI [7,2])
Age
Item
2. age >/= 70 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
3. ecog performance status </= 2.
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
4. sign a written informed consent form.
boolean
C0021430 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Renal function | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
5. adequate liver function (total bilirubin </= 2mg/dl, sgpt or sgot </= x 4 uln) and renal function creatinine clearance of >/= 50 ml/min (estimated by the cockcroft-gault [c-g] formula).
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0232804 (UMLS CUI [5])
C2711451 (UMLS CUI [6])
Gender Contraceptive methods
Item
6. male patients must use an effective contraceptive method during the study and for a minimum of 8 weeks after study treatment.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
7. baseline lvef >/= 40%.
boolean
C0428772 (UMLS CUI [1])
Heart Disease New York Heart Association Classification
Item
1. patients with >/= nyha grade 3 heart disease as assessed by history and/or physical examination.
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Hypomethylation Therapy Course Quantity | azacitidine | decitabine
Item
2. patients who received more than one full course of prior hypomethylating agents azacitidine or decitabine
boolean
C4054751 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0004475 (UMLS CUI [2])
C0049065 (UMLS CUI [3])
Comorbidity Severe | Organ dysfunction Serious | Cardiac dysfunction | Heart Disease | Abnormal renal function | Kidney Disease | Liver Dysfunction | Liver disease
Item
3. have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0349410 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C3277906 (UMLS CUI [3])
C0018799 (UMLS CUI [4])
C0151746 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0086565 (UMLS CUI [7])
C0023895 (UMLS CUI [8])
Systemic mycosis Uncontrolled | Systemic bacterial infection Uncontrolled | Systemic viral infection Uncontrolled | Communicable Disease Uncontrolled
Item
4. patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
boolean
C0553576 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C4285778 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C4285789 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0009450 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
Pregnancy | Breast Feeding
Item
5. pregnant or lactating patients.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Comorbidity At risk Patient safety | Mental disorders At risk Patient safety | Comorbidity At risk Compliance | Mental disorder At risk Compliance | Comorbidity Interferes with Informed Consent | Mental disorder Interferes with Informed Consent | Comorbidity Interferes with Study Subject Participation Status | Mental disorder Interferes with Study Subject Participation Status | Comorbidity Interferes with Follow-up | Mental disorder Interferes with Follow-up | Comorbidity Interferes with Interpretation Research results | Mental disorder Interferes with Interpretation Research results
Item
6. any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results
boolean
C0009488 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C1321605 (UMLS CUI [3,3])
C0004936 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C1321605 (UMLS CUI [4,3])
C0009488 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0021430 (UMLS CUI [5,3])
C0004936 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0021430 (UMLS CUI [6,3])
C0009488 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C2348568 (UMLS CUI [7,3])
C0004936 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C2348568 (UMLS CUI [8,3])
C0009488 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C3274571 (UMLS CUI [9,3])
C0004936 (UMLS CUI [10,1])
C0521102 (UMLS CUI [10,2])
C3274571 (UMLS CUI [10,3])
C0009488 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C0459471 (UMLS CUI [11,3])
C0683954 (UMLS CUI [11,4])
C0004936 (UMLS CUI [12,1])
C0521102 (UMLS CUI [12,2])
C0459471 (UMLS CUI [12,3])
C0683954 (UMLS CUI [12,4])
Cancer Other
Item
7. any concurrent malignancy (with the exception of exclusion # 8)
boolean
C1707251 (UMLS CUI [1])
Exception | Skin carcinoma Treated | Carcinoma in Situ Treated | Cervical Intraepithelial Neoplasia Treated | Prostate carcinoma Prostate specific antigen measurement | Recurrence Absent | Progressive Disease Absent | Hormone Therapy Initiation | Radical prostatectomy Performed
Item
8. exceptions to # 7: a) patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed; b) patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (psa) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed
boolean
C1705847 (UMLS CUI [1])
C0699893 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0007099 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0206708 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C0600139 (UMLS CUI [5,1])
C0201544 (UMLS CUI [5,2])
C0034897 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C1335499 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C0279025 (UMLS CUI [8,1])
C1704686 (UMLS CUI [8,2])
C0194810 (UMLS CUI [9,1])
C0884358 (UMLS CUI [9,2])