written informed consent
Item
1. provision of written informed consent
boolean
C0021430 (UMLS CUI [1])
age, aml, unfit for conventional chemotherapy
Item
2. male or female aged >18 years with newly diagnosed acute myeloid leukemia (aml), de novo or secondary, unfit for conventional chemotherapy
boolean
C0001779 (UMLS CUI [1])
C0023467 (UMLS CUI [2,1])
C1518321 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C3841806 (UMLS CUI [3,2])
aml in first relapse
Item
3. male or female with acute myeloid leukemia in first relapse ( > 60 years)
boolean
C0023467 (UMLS CUI [1,1])
C0035020 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
who performance status
Item
4. who performance status ³ 2, or/and unwillingness to receive conventional chemotherapy
boolean
C1298650 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
negative pregnancy test or evidence of post-menopausal status for female patients.
Item
5. negative pregnancy test or evidence of post-menopausal status for female patients.
boolean
C0032961 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
rasgrp1/aptx gene expression ratio
Item
6. rasgrp1/aptx gene expression ratio calculated at the screening >10 (part b.2 only)
boolean
C1419283 (UMLS CUI [1])
C1423885 (UMLS CUI [2])
serum bilirubin
Item
1. serum bilirubin 2 x> upper limit of normal (uln)
boolean
C1278039 (UMLS CUI [1])
ast and alt
Item
2. aspartate aminotransferase (ast/sgot) or alanine aminotransferase (alt/sgpt) >3.5 x uln
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
creatinine and creatinine clearance
Item
3. serum creatinine ³ 2.5 x uln or 24-hour creatinine clearance £ 60 ml/min (measured or calculated by cockcroft-gault)
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
apl
Item
4. patients with aml of fab m3 classification (apl)
boolean
C0023487 (UMLS CUI [1])
malignancy
Item
5. patients with a history of another primary malignancy within the previous 1 year other than basal cell carcinoma or carcinoma in situ, the patient is in remission
boolean
C0006826 (UMLS CUI [1])
central nervous system aml
Item
6. any clinically defined central nervous system aml.
boolean
C1332884 (UMLS CUI [1])
C0023467 (UMLS CUI [2])
participation status
Item
7. participation in an investigational drug study within the 30 days prior to entry
boolean
C2348568 (UMLS CUI [1])
uncontrolled infection or cns-hemorrhagic
Item
8. evidence of uncontrolled infection or cns-hemorrhagic
boolean
C0009488 (UMLS CUI [1])
hiv
Item
9. patients with documented cases of human immunodeficiency virus (hiv)
boolean
C0019682 (UMLS CUI [1])
peripheral neuropathy or neuropathic pain
Item
10. peripheral neuropathy or neuropathic pain grade > or = 2
boolean
C0031117 (UMLS CUI [1])
C0458960 (UMLS CUI [2])
hypersensitivity or intolerance to boron, mannitol, or heparin, if an indwelling catheter is used
Item
11. has known or suspected hypersensitivity or intolerance to boron, mannitol, or heparin, if an indwelling catheter is used
boolean
C0020517 (UMLS CUI [1,1])
C0006030 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0024730 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0019134 (UMLS CUI [3,2])
cardiac disease
Item
12. uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, new york heart association (nyha) class iii or iv heart failure (attachment 7,nyha classification of cardiac disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
boolean
C0018799 (UMLS CUI [1])
rasgrp1/aptx gene expression ratio
Item
13. rasgrp1/aptx gene expression ratio calculated at the screening <10 (part b.2 only)
boolean
C1419283 (UMLS CUI [1])
C1423885 (UMLS CUI [2])