AML Untreated | Blasts Percentage | Biological treatment MYELODYSPLASTIC SYNDROME | Growth Factor | Targeted Therapy MYELODYSPLASTIC SYNDROME | Exception Hypomethylation Therapy | Exception Azacitidine | Exception Decitabine | Therapeutic procedure Discontinued | Toxicity Due to Therapeutic procedure | Patient recovered | Exception Rapid disease progression | Hydroxyurea allowed | Cytarabine Dose allowed
Item
1. patients with previously untreated aml (by the who criteria, i.e. >/= 20% blasts) prior biologic therapies (such as growth factors) and targeted therapies administered for the treatment of prior myelodysplastic syndrome are allowed, with the exception of hypomethylating agents 5-azacytidine or decitabine. patients must have been off such therapy for 1 week prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease. hydroxyurea, and a single dose of cytarabine up to 3 g/m2, is permitted for control of counts prior to treatment.
boolean
C0023467 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0368761 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C1531518 (UMLS CUI [3,1])
C3463824 (UMLS CUI [3,2])
C0018284 (UMLS CUI [4])
C2985566 (UMLS CUI [5,1])
C3463824 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C4054751 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0004475 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C0049065 (UMLS CUI [8,2])
C0087111 (UMLS CUI [9,1])
C1444662 (UMLS CUI [9,2])
C0600688 (UMLS CUI [10,1])
C0678226 (UMLS CUI [10,2])
C0087111 (UMLS CUI [10,3])
C1115804 (UMLS CUI [11])
C1705847 (UMLS CUI [12,1])
C1834700 (UMLS CUI [12,2])
C0020402 (UMLS CUI [13,1])
C0683607 (UMLS CUI [13,2])
C0010711 (UMLS CUI [14,1])
C0178602 (UMLS CUI [14,2])
C0683607 (UMLS CUI [14,3])
Age
Item
2. patients >/= 60 are eligible if not a candidate for standard cytarabine plus anthracycline chemotherapy as determined by kantarjian's score (appendix d) patients younger than 60 may also be included if felt not to be a candidate for intensive anthracycline plus cytarabine based chemotherapy.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
3. performance 0-3 (ecog).
boolean
C1520224 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Exception Due to Hemolysis | Exception Due to Leukemia | Exception Due to Gilbert Disease | Renal function | Creatinine measurement, serum
Item
4. adequate liver function (total bilirubin of < 2 mg/dl) unless due to hemolysis, leukemia organ infiltration or gilbert's syndrome and renal function (creatinine < 2.5 mg/dl).
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0019054 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0023418 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C0017551 (UMLS CUI [5,3])
C0232804 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
Informed Consent
Item
5. signed informed consent
boolean
C0021430 (UMLS CUI [1])
Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Barrier Contraception Double | Childbearing Potential Urine pregnancy test negative
Item
1. nursing and pregnant females. female patients of childbearing potential and male patients should practice effective methods of contraception such as double barrier method. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. negative urine pregnancy test (women of childbearing potential)
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0004764 (UMLS CUI [5,1])
C0205173 (UMLS CUI [5,2])
C3831118 (UMLS CUI [6,1])
C0430057 (UMLS CUI [6,2])
Communicable Disease Uncontrolled
Item
2. active and uncontrolled infections.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Comorbidity Uncontrolled | Symptomatic congestive heart failure | Angina, Unstable | Cancer Other Requirement Chemotherapy | Cancer Other Requirement Therapeutic radiology procedure | Exception Skin carcinoma | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
3. uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, active significant other cancers requiring chemotherapy and/or radiation therapy within past 6 months (excluding non-melanoma skin cancer) or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0742758 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C1707251 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0392920 (UMLS CUI [4,3])
C1707251 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C1522449 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0699893 (UMLS CUI [6,2])
C0004936 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
C0748872 (UMLS CUI [8,1])
C0439801 (UMLS CUI [8,2])
C0525058 (UMLS CUI [8,3])