AML Untreated | Blasts Percentage | High risk MYELODYSPLASTIC SYNDROME IPSS | hydroxyurea | Biological treatment | Targeted Therapy | FLT3 Inhibitor | kinase inhibitor | Azacitidine | Hematopoietic Cell Growth Factors | Cytarabine Dose U/day
Item
1. previously untreated aml (>/= 20% blasts). patients with high-risk (intermediate-2 or high by ipss or ≥10% blasts) mds will also be eligible. prior therapy with hydroxyurea, biological or targeted therapy (e.g. flt3 inhibitors, other kinase inhibitors, azacitidine), or hematopoietic growth factors is allowed. a single or a two day dose of cytarabine (up to 3 g/m2) for emergency use is also allowed as prior therapy.
boolean
C0023467 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0368761 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C4319571 (UMLS CUI [3,1])
C3463824 (UMLS CUI [3,2])
C2827405 (UMLS CUI [3,3])
C0020402 (UMLS CUI [4])
C1531518 (UMLS CUI [5])
C2985566 (UMLS CUI [6])
C4086297 (UMLS CUI [7])
C3537035 (UMLS CUI [8])
C0004475 (UMLS CUI [9])
C0079490 (UMLS CUI [10])
C0010711 (UMLS CUI [11,1])
C0178602 (UMLS CUI [11,2])
C0456683 (UMLS CUI [11,3])
Age
Item
2. age >/= 60 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
3. ecog performance status </= 2.
boolean
C1520224 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Renal function | Creatinine measurement, serum
Item
4. adequate hepatic (serum total bilirubin </= 1.5 x uln, sgpt and/or sgot </= 2.5 x uln) and renal function (creatinine </= 2.0 mg/dl).
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0232804 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
Informed Consent
Item
5. patients must be willing and able to review, understand, and provide written consent before starting therapy.
boolean
C0021430 (UMLS CUI [1])
Heart Diseases New York Heart Association Classification | Ischemia | Condition cardiac Uncontrolled | Angina Pectoris | Cardiac Arrhythmia Treatment required for | Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Independent of Antihypertensive Agents | Diabetes Mellitus | Congestive heart failure
Item
1. nyha class iii or iv heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia and requiring therapy, uncontrolled hypertension (blood pressure >/= 160 systolic and >/= 110 diastolic not responsive to antihypertensive medication), diabetes mellitus, or congestive heart failure.
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0022116 (UMLS CUI [2])
C0348080 (UMLS CUI [3,1])
C0018787 (UMLS CUI [3,2])
C0205318 (UMLS CUI [3,3])
C0002962 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C0332121 (UMLS CUI [5,2])
C1868885 (UMLS CUI [6])
C0871470 (UMLS CUI [7])
C0428883 (UMLS CUI [8])
C0332291 (UMLS CUI [9,1])
C0003364 (UMLS CUI [9,2])
C0011849 (UMLS CUI [10])
C0018802 (UMLS CUI [11])
Myocardial Infarction
Item
2. myocardial infarction in the previous 12 weeks (from the start of treatment).
boolean
C0027051 (UMLS CUI [1])
Disease Uncontrolled | Communicable Disease Uncontrolled
Item
3. active and uncontrolled disease/infection as judged by the treating physician.
boolean
C0012634 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Pregnancy
Item
4. pregnancy.
boolean
C0032961 (UMLS CUI [1])
Acute Promyelocytic Leukemia
Item
5. acute promyelocytic leukemia (apl).
boolean
C0023487 (UMLS CUI [1])
Childbearing Potential Contraceptive methods Absent | Gender Contraceptive methods Absent
Item
6. women of childbearing potential and men who do not practice contraception. non-childbearing is defined as >/= 1 year postmenopausal or surgically sterilized.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Childbearing Potential Contraceptive methods Willing | Gender Contraceptive methods Willing
Item
7. women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])