Acute Myelocytic Leukemia untreated | MYELODYSPLASTIC SYNDROME High risk | Blast count procedure | Prior Therapy | hydroxyurea | Chemotherapy, single agent | decitabine | Hematopoietic Cell Growth Factors | Biological treatment | Targeted Therapy
Item
previously untreated acute myeloid leukemia (aml) or high-risk myelodysplastic syndrome (mds) (> 10% blasts). 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])
C3463824 (UMLS CUI [2,1])
C0332167 (UMLS CUI [2,2])
C0523113 (UMLS CUI [3])
C1514463 (UMLS CUI [4])
C0020402 (UMLS CUI [5])
C3846440 (UMLS CUI [6])
C0049065 (UMLS CUI [7])
C0079490 (UMLS CUI [8])
C1531518 (UMLS CUI [9])
C2985566 (UMLS CUI [10])
Age | Cytogenetic Analysis Diploidy | Cytogenetic Analysis Abnormal
Item
age > 50 years to < 74 years (diploid cytogenetics) and < 69 years (abnormal cytogenetics).
boolean
C0001779 (UMLS CUI [1])
C0752095 (UMLS CUI [2,1])
C0012568 (UMLS CUI [2,2])
C0752095 (UMLS CUI [3,1])
C0205161 (UMLS CUI [3,2])
ECOG performance status
Item
ecog performance status </= 2.
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
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 | Creatinine measurement, serum
Item
adequate liver function (total bilirubin < 2mg/dl, sgpt or sgot < x 4 uln) and renal function (serum creatinine < 2mg/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])
Fertility Contraceptive methods | Contraception, Barrier | Latex condom | Vaginal contraceptive diaphragm | CERVICAL CAP FOR CONTRACEPTIVE USE | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Postmenopausal state | Female Sterilization
Item
male and female patients who are fertile agree to use an effective barrier method of birth control (ie, latex condom, diaphragm, cervical cap, etc) to avoid pregnancy. female patients need a negative serum or urine pregnancy test within 7 days of study enrollment (applies only if patient is of childbearing potential. non-childbearing is defined as >= 1 year postmenopausal or surgically sterilized).
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0004764 (UMLS CUI [2])
C3873750 (UMLS CUI [3])
C0042241 (UMLS CUI [4])
C0493327 (UMLS CUI [5])
C3831118 (UMLS CUI [6,1])
C0430061 (UMLS CUI [6,2])
C3831118 (UMLS CUI [7,1])
C0430057 (UMLS CUI [7,2])
C0232970 (UMLS CUI [8])
C0015787 (UMLS CUI [9])
Neoadjuvant Therapy Immediate Patient need for | WBC RISING Rapid | organ involvement | Cytogenetic Analysis | Cardiac ejection fraction | Multiple gated acquisition scanning | Echocardiogram | Physical Examination
Item
patients who are considered to require immediate induction (rapidly rising wbc >/= 50,000 and/or organ involvement as per the assessment of the treating physician) can be treated without final cytogenetic results and pretreatment assessment of cardiac ejection fraction (muga or echocardiogram) if by history and physical examination patients have </= nyha class ii disease.
boolean
C0600558 (UMLS CUI [1,1])
C0205253 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
C0750397 (UMLS CUI [2,1])
C0456962 (UMLS CUI [2,2])
C0457576 (UMLS CUI [3])
C0752095 (UMLS CUI [4])
C0232174 (UMLS CUI [5])
C0521317 (UMLS CUI [6])
C2243117 (UMLS CUI [7])
C0031809 (UMLS CUI [8])
Leukemia, Myelocytic, Acute | Chromosome Aberrations | t(15;17)(PML,RARA) | t(8;21) | inv(16)
Item
aml with the following cytogenetic abnormalities: t(15;17), t(8;21), inv(16). cytogenetic results do not need to be available if immediate induction is required (see inclusion #7).
boolean
C0023467 (UMLS CUI [1])
C0008625 (UMLS CUI [2])
C1979990 (UMLS CUI [3])
C3897139 (UMLS CUI [4])
C3897144 (UMLS CUI [5])
Cardiac ejection fraction | Physical Examination
Item
cardiac ejection fraction < 30%. pretreatment assessment of ejection fraction is not necessary if immediate induction is required as long as by history and physical examination patients have </= nyha class ii disease (see inclusion #7).
boolean
C0232174 (UMLS CUI [1])
C0031809 (UMLS CUI [2])
Communicable Disease Uncontrolled | Comorbidity Severe Life Threatening | Comorbidity Severe Study Subject Participation Status Inappropriate
Item
active and uncontrolled infection or any other severe concurrent disease considered life-threatening, or which, in the judgement of the investigator and after discussion with the principal investigator, would make the patient inappropriate for entry into the study.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2826244 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C1548788 (UMLS CUI [3,4])