Recurrent Acute Myeloid Leukemia | AML Unresponsive to Standard therapy | AML Elderly | Age | Patient unfit for Chemotherapy | MYELODYSPLASTIC SYNDROME de novo IPSS | MYELODYSPLASTIC SYNDROME Treated IPSS | CMML IPSS | Exposure to azacitidine | decitabine | Toxicity Due to Therapy | Patient recovered | hydroxyurea | Erythropoiesis-stimulating Agent | Granulocyte Colony-Stimulating Factor | Growth Factor
Item
1. patients with aml, relapsed or refractory to standard therapy or elderly patients with aml (age 65 or over). patients who have aml and are younger than age 65 but considered unfit for conventional chemotherapy are eligible. patients with de novo or treated mds or cmml int-1 or above are eligible. patients may have had prior exposure to azacitidine but no more than one cycle of decitabine. patients must have been off chemotherapy for 2 weeks prior to entering this study and have recovered from the toxicities of that therapy; a caveat to this is in the case of rapidly progressive disease. hydroxyurea is permitted for control of elevated wbc prior to treatment and can be continued for the first 4 weeks of therapy. erythropoiesis stimulating agents (esas) and gcsf are allowed before therapy. esas, gcsf or other growth factors are permitted on therapy.
boolean
C1142169 (UMLS CUI [1])
C0023467 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C2936643 (UMLS CUI [2,3])
C0023467 (UMLS CUI [3,1])
C0001792 (UMLS CUI [3,2])
C0001779 (UMLS CUI [4])
C3839996 (UMLS CUI [5,1])
C0392920 (UMLS CUI [5,2])
C3463824 (UMLS CUI [6,1])
C1515568 (UMLS CUI [6,2])
C2827405 (UMLS CUI [6,3])
C3463824 (UMLS CUI [7,1])
C1522326 (UMLS CUI [7,2])
C2827405 (UMLS CUI [7,3])
C0023480 (UMLS CUI [8,1])
C2827405 (UMLS CUI [8,2])
C0332157 (UMLS CUI [9,1])
C0004475 (UMLS CUI [9,2])
C0049065 (UMLS CUI [10])
C0600688 (UMLS CUI [11,1])
C0678226 (UMLS CUI [11,2])
C0087111 (UMLS CUI [11,3])
C1115804 (UMLS CUI [12])
C0020402 (UMLS CUI [13])
C2917382 (UMLS CUI [14])
C0079459 (UMLS CUI [15])
C0018284 (UMLS CUI [16])
ECOG performance status
Item
2. performance 0-2 (ecog).
boolean
C1520224 (UMLS CUI [1])
Cardiac function Echocardiography second | New York Heart Association Classification
Item
3. adequate cardiac functions assessed by 2d echo (nyha cardiac iii-iv excluded).
boolean
C0232164 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0205436 (UMLS CUI [1,3])
C1275491 (UMLS CUI [2])
ECG pre treatment
Item
4. pre-treatment ekg
boolean
C0013798 (UMLS CUI [1,1])
C2709094 (UMLS CUI [1,2])
Organ function | Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
5. adequate end organ function with creatinine </= 2mg/dl and total bilirubin </= 2mg/dl, ast and alt </= or = 2.5 x institutional uln.
boolean
C0678852 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
Comorbidity Significant;Absent | Absence Heart failure Uncontrolled | Unstable Angina Absent | Cardiac Arrhythmia Absent | Mental disorders Absent | Mental disorders Exclude Informed Consent
Item
6. absence of significant intercurrent illness such as uncontrolled heart failure, unstable angina, cardiac arrhythmia and psychiatric illness which precludes the giving of informed consent.
boolean
C0009488 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C0018801 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
C0002965 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0003811 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0004936 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0004936 (UMLS CUI [6,1])
C0332196 (UMLS CUI [6,2])
C0021430 (UMLS CUI [6,3])
Informed Consent
Item
7. signed informed consent
boolean
C0021430 (UMLS CUI [1])
Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods
Item
1. nursing and pregnant females. patients of childbearing potential should practice effective methods of contraception. should a woman become preg-nant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Communicable Disease Uncontrolled
Item
2. current uncontrolled infections.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Comorbidity Uncontrolled | Symptomatic congestive heart failure | Angina, Unstable | 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, 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])
C0004936 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C0748872 (UMLS CUI [5,1])
C0439801 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
Chronic Kidney Disease Stage
Item
4. chronic kidney disease > stage 3.
boolean
C1561643 (UMLS CUI [1,1])
C2074731 (UMLS CUI [1,2])
HIV Infection
Item
5. hiv infection.
boolean
C0019693 (UMLS CUI [1])