age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Patients with a confirmed diagnosis of AML according to WHO classification (excluding acute promyelocytic leukaemia)
Item
Patients with a confirmed diagnosis of AML according to WHO classification (excluding acute promyelocytic leukaemia)
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0023467 (UMLS CUI 2011AA)
91861009 (SNOMED CT 2011_0131)
10000880 (MedDRA 14.1)
C92.0 (ICD-10-CM Version 2010)
205.0 (ICD-9-CM Version 2011)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C0451584 (UMLS CUI 2011AA)
273931002 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0023487 (UMLS CUI 2011AA)
110004001 (SNOMED CT 2011_0131)
10001019 (MedDRA 14.1)
C92.4 (ICD-10-CM Version 2010)
Patients who have received one previous standard dose ara-C-containing regimen aiming at induction of complete remission (CR) and who have > 5 % remaining blast cells in bone marrow following the first course of remission-induction or by other means documented residual disease (i.e. circulating blasts, persistent chloromas, other evident disease from day 12 on).
Item
Patients who have received one previous standard dose ara-C-containing regimen aiming at induction of complete remission (CR) and who have > 5 % remaining blast cells in bone marrow following the first course of remission-induction or by other means documented residual disease (i.e. circulating blasts, persistent chloromas, other evident disease from day 12 on).
boolean
C2828392 (UMLS CUI 2011AA)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0010711 (UMLS CUI 2011AA)
89265009 (SNOMED CT 2011_0131)
C0205263 (UMLS CUI 2011AA)
16404004 (SNOMED CT 2011_0131)
C0677874 (UMLS CUI 2011AA)
103338009 (SNOMED CT 2011_0131)
C0543478 (UMLS CUI 2011AA)
17964000 (SNOMED CT 2011_0131)
C0175630 (UMLS CUI 2011AA)
65929005 (SNOMED CT 2011_0131)
C0368761 (UMLS CUI 2011AA)
312256009 (SNOMED CT 2011_0131)
MTHU005201 (LOINC Version 232)
C0205322 (UMLS CUI 2011AA)
CL414320 (UMLS CUI 2011AA)
188737002, 94719007 (SNOMED CT 2011_0131)
10008583 (MedDRA 14.1)
205.3 (ICD-9-CM Version 2011)
Patients from whom samples for determination of hENT1 status on leukemic blast cells can be taken and prepared at diagnosis and/or at baseline
Item
Patients from whom samples for determination of hENT1 status on leukemic blast cells can be taken and prepared at diagnosis and/or at baseline
boolean
CL423120 (UMLS CUI 2011AA)
C1148554 (UMLS CUI 2011AA)
C1130454 (UMLS CUI 2011AA)
C0449438 (UMLS CUI 2011AA)
263490005 (SNOMED CT 2011_0131)
MTHU015827 (LOINC Version 232)
C2697913 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1442488 (UMLS CUI 2011AA)
Patients must have ECOG performance status (PS) of 0 - 2
Item
Patients must have ECOG performance status (PS) of 0 - 2
boolean
C1828078 (UMLS CUI 2011AA)
425389002 (SNOMED CT 2011_0131)
C1827388 (UMLS CUI 2011AA)
422512005 (SNOMED CT 2011_0131)
C1828242 (UMLS CUI 2011AA)
422894000 (SNOMED CT 2011_0131)
Left ventricular ejection fraction (LVEF) must be >= 45 % as measured by MUGA scan or 2D ECHO within 14 days prior to start of therapy.
Item
Left ventricular ejection fraction (LVEF) must be >= 45 % as measured by MUGA scan or 2D ECHO within 14 days prior to start of therapy.
boolean
C0428772 (UMLS CUI 2011AA)
250908004 (SNOMED CT 2011_0131)
10069170 (MedDRA 14.1)
C0521317 (UMLS CUI 2011AA)
404221001 (SNOMED CT 2011_0131)
10028211 (MedDRA 14.1)
C0013524 (UMLS CUI 2011AA)
Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this study
Item
Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this study
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0279752 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0543467 (UMLS CUI 2011AA)
83578000 (SNOMED CT 2011_0131)
10051332 (MedDRA 14.1)
MTHU000079 (LOINC Version 232)
C0021359 (UMLS CUI 2011AA)
8619003 (SNOMED CT 2011_0131)
10021926 (MedDRA 14.1)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0430061 (UMLS CUI 2011AA)
166435006 (SNOMED CT 2011_0131)
C0430057 (UMLS CUI 2011AA)
167254001 (SNOMED CT 2011_0131)
10036577 (MedDRA 14.1)
Male and female patients must use acceptable contraceptive methods for the duration of time on study, and males also for 3 months after the last elacytarabine dose
Item
Male and female patients must use acceptable contraceptive methods for the duration of time on study, and males also for 3 months after the last elacytarabine dose
boolean
C0024554 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C1707141 (UMLS CUI 2011AA)
Patients must be capable of understanding and complying with parameters as outlined in the protocol, and able and willing to sign a written informed consent form
Item
Patients must be capable of understanding and complying with parameters as outlined in the protocol, and able and willing to sign a written informed consent form
boolean
C1273101 (UMLS CUI 2011AA)
395659009 (SNOMED CT 2011_0131)
C0525058 (UMLS CUI 2011AA)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C2348583 (UMLS CUI 2011AA)
Patients must have the following clinical laboratory values:
Item
Patients must have the following clinical laboratory values:
boolean
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
C1522609 (UMLS CUI 2011AA)
Serum creatinine <= 1.5 x the institutional upper limit of normal (ULN)
Item
Serum creatinine <= 1.5 x the institutional upper limit of normal (ULN)
boolean
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
Total bilirubin <= 1.5 x the ULN according to national prescribing information unless considered due to Gilbert's syndrome
Item
Total bilirubin <= 1.5 x the ULN according to national prescribing information unless considered due to Gilbert's syndrome
boolean
C0201913 (UMLS CUI 2011AA)
359986008 (SNOMED CT 2011_0131)
10004696 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
CL415062 (UMLS CUI 2011AA)
C0033080 (UMLS CUI 2011AA)
16076005 (SNOMED CT 2011_0131)
CL414911 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0017551 (UMLS CUI 2011AA)
27503000 (SNOMED CT 2011_0131)
10018267 (MedDRA 14.1)
E80.4 (ICD-10-CM Version 2010)
Alanine aminotransferase (ALT) (SGPT), or aspartate aminotransferase (AST) (SGOT) <= 2.5 x the ULN unless considered due to organ leukemic involvement
Item
Alanine aminotransferase (ALT) (SGPT), or aspartate aminotransferase (AST) (SGOT) <= 2.5 x the ULN unless considered due to organ leukemic involvement
boolean
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0178784 (UMLS CUI 2011AA)
MTHU020170 (LOINC Version 232)
C0023418 (UMLS CUI 2011AA)
93143009 (SNOMED CT 2011_0131)
10024288 (MedDRA 14.1)
C95.9 (ICD-10-CM Version 2010)
208.9 (ICD-9-CM Version 2011)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
Patients must be eligible for administration of idarubicin according to current national prescribing information for idarubicin
Item
Patients must be eligible for administration of idarubicin according to current national prescribing information for idarubicin
boolean
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
C1533734 (UMLS CUI 2011AA)
416118004 (SNOMED CT 2011_0131)
C0020789 (UMLS CUI 2011AA)
372539000 (SNOMED CT 2011_0131)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
CL415062 (UMLS CUI 2011AA)
C0033080 (UMLS CUI 2011AA)
16076005 (SNOMED CT 2011_0131)
CL414911 (UMLS CUI 2011AA)
A history of allergic reactions to egg, idarubicin and/or other anthracyclines or other components of the products. A history of allergic reactions to ara-C of CTCAE grade 3 or 4
Item
A history of allergic reactions to egg, idarubicin and/or other anthracyclines or other components of the products. A history of allergic reactions to ara-C of CTCAE grade 3 or 4
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C1527304 (UMLS CUI 2011AA)
421668005 (SNOMED CT 2011_0131)
10001718 (MedDRA 14.1)
T78.40 (ICD-10-CM Version 2010)
C0013710 (UMLS CUI 2011AA)
102263004 (SNOMED CT 2011_0131)
C0020789 (UMLS CUI 2011AA)
372539000 (SNOMED CT 2011_0131)
C0282564 (UMLS CUI 2011AA)
372540003 (SNOMED CT 2011_0131)
C0010711 (UMLS CUI 2011AA)
89265009 (SNOMED CT 2011_0131)
C1519275 (UMLS CUI 2011AA)
CL427997 (UMLS CUI 2011AA)
Persistent clinically significant and relevant toxicities from the previous course of chemotherapy
Item
Persistent clinically significant and relevant toxicities from the previous course of chemotherapy
boolean
C0205322 (UMLS CUI 2011AA)
C0040539 (UMLS CUI 2011AA)
C1314792 (UMLS CUI 2011AA)
134198009 (SNOMED CT 2011_0131)
C1514457 (UMLS CUI 2011AA)
A cancer history, that according to the investigator might confound the assessment of the study endpoints
Item
A cancer history, that according to the investigator might confound the assessment of the study endpoints
boolean
C2735088 (UMLS CUI 2011AA)
MTHU034770 (LOINC Version 232)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C1516048 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C2349179 (UMLS CUI 2011AA)
Patients with prior treatment with a cumulative dose of doxorubicin or equivalent exceeding 300 mg/m2 according to the following calculation index: X/300 + Y/160 < 1 where X is the doxorubicin or equivalent dose in mg/m2 and Y is the mitoxantrone dose in mg/m2. These calculations are to be used as guidance as there is no maximum cumulative dose defined in the summary of product characteristics (SPC) for idarubicin. The patient should tolerate minimum one course of combination therapy
Item
Patients with prior treatment with a cumulative dose of doxorubicin or equivalent exceeding 300 mg/m2 according to the following calculation index: X/300 + Y/160 < 1 where X is the doxorubicin or equivalent dose in mg/m2 and Y is the mitoxantrone dose in mg/m2. These calculations are to be used as guidance as there is no maximum cumulative dose defined in the summary of product characteristics (SPC) for idarubicin. The patient should tolerate minimum one course of combination therapy
boolean
C1514463 (UMLS CUI 2011AA)
CL426125 (UMLS CUI 2011AA)
C0013089 (UMLS CUI 2011AA)
68444001 (SNOMED CT 2011_0131)
MTHU004184 (LOINC Version 232)
CL415123 (UMLS CUI 2011AA)
C1441506 (UMLS CUI 2011AA)
C0918012 (UMLS CUI 2011AA)
C0026259 (UMLS CUI 2011AA)
386913001 (SNOMED CT 2011_0131)
C0220845 (UMLS CUI 2011AA)
C1709515 (UMLS CUI 2011AA)
C0020789 (UMLS CUI 2011AA)
372539000 (SNOMED CT 2011_0131)
C0556895 (UMLS CUI 2011AA)
229554006 (SNOMED CT 2011_0131)
Active heart disease including myocardial infarction within the previous 3 months, symptomatic coronary disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure. Any NYHA grade 3 or 4
Item
Active heart disease including myocardial infarction within the previous 3 months, symptomatic coronary disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure. Any NYHA grade 3 or 4
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
I51.9 (ICD-10-CM Version 2010)
429.9 (ICD-9-CM Version 2011)
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C0010068 (UMLS CUI 2011AA)
53741008 (SNOMED CT 2011_0131)
10068617 (MedDRA 14.1)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
C0018802 (UMLS CUI 2011AA)
42343007 (SNOMED CT 2011_0131)
10007559 (MedDRA 14.1)
MTHU020787 (LOINC Version 232)
I50.9 (ICD-10-CM Version 2010)
428.0 (ICD-9-CM Version 2011)
C1319795 (UMLS CUI 2011AA)
420913000 (SNOMED CT 2011_0131)
10064081 (MedDRA 14.1)
C1319796 (UMLS CUI 2011AA)
422293003 (SNOMED CT 2011_0131)
10064082 (MedDRA 14.1)
Known positive status for human immunodeficiency virus (HIV)
Item
HIV Seropositivity
boolean
C0019699 (UMLS CUI 2011AA)
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
Pregnant and nursing patients are excluded because the effects of elacytarabine on a fetus or a nursing child are unknown
Item
Pregnant and nursing patients are excluded because the effects of elacytarabine on a fetus or a nursing child are unknown
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
Uncontrolled intercurrent illness including, but not limited to uncontrolled infection, or psychiatric illness/social situations that may reduce compliance with study requirements
Item
Uncontrolled intercurrent illness including, but not limited to uncontrolled infection, or psychiatric illness/social situations that may reduce compliance with study requirements
boolean
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0277557 (UMLS CUI 2011AA)
88472004 (SNOMED CT 2011_0131)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
C0851364 (UMLS CUI 2011AA)
10041244 (MedDRA 14.1)
C0392756 (UMLS CUI 2011AA)
260400001 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)
Patients receiving hydroxyurea within the last 12 hours prior to treatment on this protocol or any other investigational or standard cytotoxic treatment within the last 14 days, except the first remission-induction course
Item
Patients receiving hydroxyurea within the last 12 hours prior to treatment on this protocol or any other investigational or standard cytotoxic treatment within the last 14 days, except the first remission-induction course
boolean
C1514756 (UMLS CUI 2011AA)
C0020402 (UMLS CUI 2011AA)
56602009 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0677881 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C1514832 (UMLS CUI 2011AA)
Any medical condition, which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities
Item
Any medical condition, which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities
boolean
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C0332167 (UMLS CUI 2011AA)
15508007 (SNOMED CT 2011_0131)
C0040539 (UMLS CUI 2011AA)