Informed Consent
Item
1. sign an irb-approved informed consent document.
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. age 18 to 60. patients above the age of 60 only with principal investigator (pi) approval
boolean
C0001779 (UMLS CUI [1])
Leukemia, Myelocytic, Acute | Exception Acute Promyelocytic Leukemia | High risk MYELODYSPLASTIC SYNDROME IPSS | Blasts Percentage | Leukemia, Myelomonocytic, Chronic | Hydrea | Cytarabine Dose U/day
Item
3. diagnosis of newly diagnosed aml [other than acute promyelocytic leukemia (apl)] or high-risk (intermediate-2 or high by ipss or > 10% blasts, including cmml) mds. prior therapy with hydrea and the use of a single or a two day dose of cytarabine (up to 3 g/m2) for emergency use up to 24 hours prior to start of study therapy is allowed. prior therapy for mds or other ahd is not allowed.
boolean
C0023467 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0023487 (UMLS CUI [2,2])
C4319571 (UMLS CUI [3,1])
C3463824 (UMLS CUI [3,2])
C2827405 (UMLS CUI [3,3])
C0368761 (UMLS CUI [4,1])
C0439165 (UMLS CUI [4,2])
C0023480 (UMLS CUI [5])
C0591617 (UMLS CUI [6])
C0010711 (UMLS CUI [7,1])
C0178602 (UMLS CUI [7,2])
C0456683 (UMLS CUI [7,3])
ECOG performance status
Item
4. ecog performance status of </= 3 at study entry.
boolean
C1520224 (UMLS CUI [1])
Organ function | Exception Due to Leukemia | Creatinine measurement, serum | Serum total bilirubin measurement | Alanine aminotransferase measurement | Relationship Disease
Item
5. organ function as defined below (unless due to leukemia): serum creatinine </= 3 mg/dl total bilirubin </= 2.5 mg/dl , alt (sgpt) </= 3 * uln or </= 5 * uln if related to disease.
boolean
C0678852 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0023418 (UMLS CUI [2,3])
C0201976 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0439849 (UMLS CUI [6,1])
C0012634 (UMLS CUI [6,2])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Contraceptive methods | Gender Preventing Reproduction | Gender Use of Condom | Partner Childbearing Potential
Item
6. women of childbearing potential must have a negative serum or urine pregnancy test within 7 days and must agree to practice acceptable contraceptive methods. men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C1292733 (UMLS CUI [4,2])
C0035150 (UMLS CUI [4,3])
C0079399 (UMLS CUI [5,1])
C1524063 (UMLS CUI [5,2])
C0009653 (UMLS CUI [5,3])
C0682323 (UMLS CUI [6,1])
C3831118 (UMLS CUI [6,2])
Cardiac ejection fraction Echocardiography | Cardiac ejection fraction MUGA scan
Item
7. cardiac ejection fraction >/= 40% (by either cardiac echo or muga scan). documentation of recent (</= 6 months from screening) outside reports is acceptable.
boolean
C0232174 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0232174 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
Breast Feeding
Item
1. breast feeding females
boolean
C0006147 (UMLS CUI [1])
Communicable Diseases Uncontrolled | Virus Diseases | Bacterial Infections | Mycoses
Item
2. patients with uncontrolled active infections (viral, bacterial, and fungal are not eligible).
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0042769 (UMLS CUI [2])
C0004623 (UMLS CUI [3])
C0026946 (UMLS CUI [4])
Secondary Malignant Neoplasm
Item
3. patients with active secondary malignancy will not be eligible.
boolean
C3266877 (UMLS CUI [1])