informed consent
Item
1. written signed informed consent.
boolean
C0021430 (UMLS CUI [1])
age
Item
2. ≥18 years of age.
boolean
C0001779 (UMLS CUI [1])
MDS, CMML, AML
Item
3. diagnosed mds with 5% or more marrow blasts and ipss risk intermediate 2 or high risk; or chronic myelomonocytic leukemia (cmml-2); or aml with 20-30% bone marrow blasts.
boolean
C3463824 (UMLS CUI [1])
C0023480 (UMLS CUI [2])
C0023467 (UMLS CUI [3])
C1982687 (UMLS CUI [4])
failed therapy with azacitidine
Item
4. patients who have failed therapy with azacitidine.
boolean
C0004475 (UMLS CUI [1,1])
C0438286 (UMLS CUI [1,2])
ECOG
Item
5. performance status 0-2 (ecog scale).
boolean
C1520224 (UMLS CUI [1])
hepatic and renal function
Item
6. adequate hepatic (bilirubin < 1.5 x uln or ast< 2.5 x uln) and renal functions (creatinine <1.5 x uln).
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
nursing and pregnant females
Item
1. nursing and pregnant females.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
childbearing potential, contraception
Item
2. females of childbearing potential and males not willing to practice an effective method of contraception whilst receiving decitabine and for 2 months after the last infusion.
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
malignancy
Item
3. patients with previous malignancy or concurrent malignancy.
boolean
C0006826 (UMLS CUI [1])
comorbidity
Item
4. uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure and unstable angina pectoris.
boolean
C0009488 (UMLS CUI [1])
oral corticosteroids
Item
5. ongoing oral corticosteroids are not permitted. however, use of corticosteroids (topical and inhaled) is permitted and prophylactic steroids are allowed for transfusion reactions.
boolean
C0001617 (UMLS CUI [1])
investigational agent
Item
6. patients who have received any investigational agent within the 30 days preceding the first dose of study drug.
boolean
C1875319 (UMLS CUI [1])
chemotherapy
Item
7. patients who have received prior intensive combination chemotherapy or high-dose cytarabine (>/= 1g/m*2 per dose). (prior biologic therapies, targeted therapies and single agent chemotherapy are allowed).
boolean
C0392920 (UMLS CUI [1])
C0010711 (UMLS CUI [2])
infection
Item
8. patients who have an active viral or bacterial infection. note: no patient is allowed to enter the study unless infections have been fully treated and the patient has remained afebrile for 7 days without antibiotics.
boolean
C0009450 (UMLS CUI [1])
autoimmune hemolytic anemia or immune thrombocytopenia
Item
9. patients who have concurrent autoimmune hemolytic anemia or immune thrombocytopenia.
boolean
C0002880 (UMLS CUI [1])
C0272286 (UMLS CUI [2])
prior therapy with decitabine
Item
10. patients who have previously been treated with decitabine.
boolean
C0049065 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
hiv
Item
11. patients who have known positive serology for hiv.
boolean
C0019682 (UMLS CUI [1])
condition limiting study protocol
Item
12. patients with a condition that may be unable to comply with the treatment and monitoring requirements of the study.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])