AML Untreated | High risk MDS | Blasts Percentage | IPSS | hydroxyurea | Hematopoietic Cell Growth Factors | Azacitidine | ATRA | Cytarabine Dose
Item
1. patients with previously untreated aml or high risk mds (>/= 10 % blasts or ipss >/= intermediate-2). prior therapy with hydroxyurea, hematopoietic growth factors, azacytidine, atra, or an isolated dose of cytarabine up to 2g is allowed. patients with history of mds transformed to aml are eligible regardless of their prior therapy for mds provided this will be their first induction therapy for aml.
boolean
C0023467 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C4319571 (UMLS CUI [2,1])
C3463824 (UMLS CUI [2,2])
C0368761 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
C2827405 (UMLS CUI [4])
C0020402 (UMLS CUI [5])
C0079490 (UMLS CUI [6])
C0004475 (UMLS CUI [7])
C0040845 (UMLS CUI [8])
C0010711 (UMLS CUI [9,1])
C0178602 (UMLS CUI [9,2])
Age
Item
2. age >/= 60 years. patients aged < 60 years who are unsuitable for standard induction therapy may be eligible after discussion with pi
boolean
C0001779 (UMLS CUI [1])
Organ function | Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum
Item
3. adequate organ function as defined below: liver function (bilirubin </= 2mg/dl, ast and/or alt </=3 x uln) kidney function (creatinine </= 1.5 x uln ).
boolean
C0678852 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0232804 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
ECOG performance status
Item
4. ecog performance status of </= 2.
boolean
C1520224 (UMLS CUI [1])
Childbearing Potential Urine pregnancy test negative
Item
5. a negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
Informed Consent | Informed Consent Patient Representative
Item
6. patient must have the ability to understand the requirements of the study and signed informed consent. a signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Decitabine allowed | Exception Disease Progression AML
Item
7. prior therapy with decitabine will be allowed unless the patient experienced progression to aml while being treated with decitabine.
boolean
C0049065 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0242656 (UMLS CUI [2,2])
C0023467 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
1. pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Comorbidity Uncontrolled | Communicable Disease Uncontrolled | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
2. uncontrolled intercurrent illness including, but not limited to ongoing or active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
Hypersensitivity Component Chemotherapy Regimen
Item
3. patient with documented hypersensitivity to any of the components of the chemotherapy program.
boolean
C0020517 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
Females & males of reproductive potential Contraceptive methods Absent | Childbearing Potential Contraceptive methods Willing | Gender Contraceptive methods Willing
Item
4. men and women of childbearing potential who do not practice contraception. women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0600109 (UMLS CUI [3,3])