AML Untreated | Blasts Percentage | High risk MYELODYSPLASTIC SYNDROME | Blasts Percentage Bone Marrow | Leukemia, Myelomonocytic, Chronic | hydroxyurea | Biological treatment | Targeted Therapy | FLT3 Inhibitor | kinase inhibitor | Hematopoietic Cell Growth Factors | Cytarabine Dose
Item
1. previously untreated aml (>/= 20% blasts). patients with high-risk mds (defined as having >/= 10% blasts in the bone marrow) or patients with chronic myelomonocytic leukemia (cmml) (having >/= 10% blasts in the bone marrow) may also be eligible after discussion with principal investigator (pi). prior therapy with hydroxyurea, biological or targeted therapy (e.g. flt3 inhibitors, other kinase inhibitors), or hematopoietic growth factors is allowed, however prior therapy with chemotherapy agents for the disease under study is not allowed. patients may have received one dose of cytarabine (up to 2 g/m2) administered at presentation for control of hyperleucocytosis. for patients with prior mds or cmml who transformed to aml, therapy received for mds is not considered as prior therapy for aml.
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])
C0368761 (UMLS CUI [4,1])
C0439165 (UMLS CUI [4,2])
C0005953 (UMLS CUI [4,3])
C0023480 (UMLS CUI [5])
C0020402 (UMLS CUI [6])
C1531518 (UMLS CUI [7])
C2985566 (UMLS CUI [8])
C4086297 (UMLS CUI [9])
C3537035 (UMLS CUI [10])
C0079490 (UMLS CUI [11])
C0010711 (UMLS CUI [12,1])
C0178602 (UMLS CUI [12,2])
Age | Patients Inappropriate Cytotoxic Chemotherapy | Cytotoxic Chemotherapy Refused | Patients unfit Chemotherapy | Chemotherapy Receive Unable
Item
2. age >/= 60 years and not candidates for conventional cytotoxic chemotherapy or refuse it; or patients below the age of 60 years who are considered unfit and/or unable to tolerate standard chemotherapy at the discretion of the treating physician or the principal investigator. "
boolean
C0001779 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0677881 (UMLS CUI [2,3])
C0677881 (UMLS CUI [3,1])
C1705116 (UMLS CUI [3,2])
C0030705 (UMLS CUI [4,1])
C0850765 (UMLS CUI [4,2])
C0392920 (UMLS CUI [4,3])
C0392920 (UMLS CUI [5,1])
C1514756 (UMLS CUI [5,2])
C1299582 (UMLS CUI [5,3])
ECOG performance status
Item
3. eastern cooperative oncology group 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 upper limit normal (uln), alanine aminotransferase and/or aspartate transaminase </= 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])
Left ventricular ejection fraction MUGA scan | Left ventricular ejection fraction Echocardiography
Item
5. left ventricular ejection fraction (lvef) at least 40% by multiple gated acquisition (muga) scan or echocardiogram (echo)
boolean
C0428772 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Informed Consent
Item
6. patients must be willing and able to review, understand, and provide written consent before starting therapy.
boolean
C0021430 (UMLS CUI [1])
Female Sterilization | Infertility | Postmenopausal state | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Contraceptive methods | Male sterilization | Gender Infertility | Gender Contraceptive methods
Item
7. females must be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months) or if of childbearing potential, must have a negative serum pregnancy test within 14 days before the start of the treatment. women of childbearing potential may have a urine pregnancy test, instead of a serum pregnancy test. if either the serum or urine pregnancy test is equivocally negative the patient will be eligible for the protocol. women of childbearing potential must agree to use an adequate method of contraception during the study until 30 days after the last treatment. males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 30 days after the last treatment.
boolean
C0015787 (UMLS CUI [1])
C0021359 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0430061 (UMLS CUI [4,2])
C3831118 (UMLS CUI [5,1])
C0430057 (UMLS CUI [5,2])
C3831118 (UMLS CUI [6,1])
C0700589 (UMLS CUI [6,2])
C0024559 (UMLS CUI [7])
C0079399 (UMLS CUI [8,1])
C0021359 (UMLS CUI [8,2])
C0079399 (UMLS CUI [9,1])
C0700589 (UMLS CUI [9,2])
Heart Disease New York Heart Association Classification | Ischemia | Condition cardiac Uncontrolled | Angina Pectoris | Cardiac Arrhythmia Treatment required for | Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Unresponsive to Antihypertensive Agents | Diabetic - poor control | Congestive heart failure Uncontrolled
Item
1. new york heart association class iii or iv heart disease, active ischemia or any other uncontrolled cardiac condition such as active angina pectoris, clinically significant cardiac arrhythmia that requires therapy in the opinion of the treating physician or pi, uncontrolled hypertension (blood pressure > 160 systolic and > 110 diastolic not responsive to antihypertensive medication), uncontrolled diabetes mellitus in the opinion of the treating physician or pi, or uncontrolled congestive heart failure in the opinion of the treating physician or pi.
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])
C0205269 (UMLS CUI [9,1])
C0003364 (UMLS CUI [9,2])
C0421258 (UMLS CUI [10])
C0018802 (UMLS CUI [11,1])
C0205318 (UMLS CUI [11,2])
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 | Breast Feeding
Item
4. pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Seropositivity
Item
5. known human immunodeficiency virus seropositivity
boolean
C0019699 (UMLS CUI [1])
Other medical condition Interferes with Study Subject Participation Status | Mental condition Interferes with Study Subject Participation Status | Social Condition Interferes with Study Subject Participation Status | Other medical condition Interferes with Protocol Compliance | Mental condition Interferes with Protocol Compliance | Social Condition Interferes with Protocol Compliance | Other medical condition At risk Patient safety | Mental condition At risk Patient safety | Social Condition At risk Patient safety
Item
6. any other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the investigator or medical monitor
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0037403 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C3840291 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C0037403 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C3843040 (UMLS CUI [7,1])
C1444641 (UMLS CUI [7,2])
C1113679 (UMLS CUI [7,3])
C3840291 (UMLS CUI [8,1])
C1444641 (UMLS CUI [8,2])
C1113679 (UMLS CUI [8,3])
C0037403 (UMLS CUI [9,1])
C1444641 (UMLS CUI [9,2])
C1113679 (UMLS CUI [9,3])
Acute Promyelocytic Leukemia
Item
7. acute promyelocytic leukemia (apl).
boolean
C0023487 (UMLS CUI [1])