age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
confirmed diagnosis of AML according to WHO classification (excluding acute promyelocytic leukaemia) who have received two or three previous induction/re-induction regimens or patients of age >= 65 with adverse cytogenetics who have received 1-3 previous induction/re-induction regimens. One of the (re-)induction regimens could be stem cell transplantation (SCT) for achievement of remission. Maintenance and consolidation (including SCT) may have been given, but are not counted as previous regimens.
Item
confirmed diagnosis of AML according to WHO classification (excluding acute promyelocytic leukaemia) who have received two or three previous induction/re-induction regimens or patients of age >= 65 with adverse cytogenetics who have received 1-3 previous induction/re-induction regimens. One of the (re-)induction regimens could be stem cell transplantation (SCT) for achievement of remission. Maintenance and consolidation (including SCT) may have been given, but are not counted as previous regimens.
boolean
C0750484 (UMLS CUI 2011AA)
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)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0600558 (UMLS CUI 2011AA)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0008625 (UMLS CUI 2011AA)
C1504389 (UMLS CUI 2011AA)
10063581 (MedDRA 14.1)
bone marrow aspirates and/or biopsies must contain > 5 % leukaemic blast cells or patient must have biopsy-proven extramedullary AML, or patient's peripheral blood shows occurrence of leukaemic blast cells
Item
bone marrow aspirates and/or biopsies must contain > 5 % leukaemic blast cells or patient must have biopsy-proven extramedullary AML, or patient's peripheral blood shows occurrence of leukaemic blast cells
boolean
C0857285 (UMLS CUI 2011AA)
10005981 (MedDRA 14.1)
C0005954 (UMLS CUI 2011AA)
234326005 (SNOMED CT 2011_0131)
10004737 (MedDRA 14.1)
41.31 (ICD-9-CM Version 2011)
C2697913 (UMLS CUI 2011AA)
C0229664 (UMLS CUI 2011AA)
119273009 (SNOMED CT 2011_0131)
MTHU003709 (LOINC Version 232)
C0456369 (UMLS CUI 2011AA)
277025001 (SNOMED CT 2011_0131)
C1517060 (UMLS CUI 2011AA)
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)
Patients must
Item
Needed (qualifier value), Needs
boolean
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
have never attained CR or CRi (primary refractory), or
Item
have never attained CR or CRi (primary refractory), or
boolean
C2003901 (UMLS CUI 2011AA)
C0680378 (UMLS CUI 2011AA)
C0677874 (UMLS CUI 2011AA)
103338009 (SNOMED CT 2011_0131)
CL414906 (UMLS CUI 2011AA)
C2347678 (UMLS CUI 2011AA)
have failed initial induction therapy, and have attained CR or CRi after salvage therapy(ies), and then relapsed within < 6 months, or
Item
have failed initial induction therapy, and have attained CR or CRi after salvage therapy(ies), and then relapsed within < 6 months, or
boolean
C0231175 (UMLS CUI 2011AA)
C0205265 (UMLS CUI 2011AA)
884001 (SNOMED CT 2011_0131)
C0600558 (UMLS CUI 2011AA)
C0680378 (UMLS CUI 2011AA)
C0677874 (UMLS CUI 2011AA)
103338009 (SNOMED CT 2011_0131)
CL414906 (UMLS CUI 2011AA)
C2347678 (UMLS CUI 2011AA)
C0085405 (UMLS CUI 2011AA)
10068833 (MedDRA 14.1)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
have attained CR or CRi after initial induction therapy and relapsed within <12 months, and failed to respond to salvage therapy(ies), or
Item
have attained CR or CRi after initial induction therapy and relapsed within <12 months, and failed to respond to salvage therapy(ies), or
boolean
C0680378 (UMLS CUI 2011AA)
C0677874 (UMLS CUI 2011AA)
103338009 (SNOMED CT 2011_0131)
CL414906 (UMLS CUI 2011AA)
C2347678 (UMLS CUI 2011AA)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C0205265 (UMLS CUI 2011AA)
884001 (SNOMED CT 2011_0131)
C0600558 (UMLS CUI 2011AA)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C0438286 (UMLS CUI 2011AA)
266721009 (SNOMED CT 2011_0131)
10063670 (MedDRA 14.1)
C0085405 (UMLS CUI 2011AA)
10068833 (MedDRA 14.1)
have relapsed after the latest CR or CRi within < 6 months
Item
have relapsed after the latest CR or CRi within < 6 months
boolean
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C1517741 (UMLS CUI 2011AA)
C0677874 (UMLS CUI 2011AA)
103338009 (SNOMED CT 2011_0131)
CL414906 (UMLS CUI 2011AA)
C2347678 (UMLS CUI 2011AA)
Patients younger than 65 years should have received previous treatment with cytarabine
Item
Patients younger than 65 years should have received previous treatment with cytarabine
boolean
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C1514463 (UMLS CUI 2011AA)
C0010711 (UMLS CUI 2011AA)
89265009 (SNOMED CT 2011_0131)
Patients must have recovered from previous bone marrow and/or stem cell transplantation to a stage that the patient can tolerate the study treatment. There is no restriction on number of regimens or type of treatment administered for maintenance or consolidation during previous stages of the disease
Item
Patients must have recovered from previous bone marrow and/or stem cell transplantation to a stage that the patient can tolerate the study treatment. There is no restriction on number of regimens or type of treatment administered for maintenance or consolidation during previous stages of the disease
boolean
C1115804 (UMLS CUI 2011AA)
MTHU014522 (LOINC Version 232)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0005961 (UMLS CUI 2011AA)
23719005 (SNOMED CT 2011_0131)
10061730 (MedDRA 14.1)
41.00 (ICD-9-CM Version 2011)
C1504389 (UMLS CUI 2011AA)
10063581 (MedDRA 14.1)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
ECOG performance status (PS) of 0 - 2
Item
ECOG performance status (PS) of 0 - 2
boolean
C1520224 (UMLS CUI 2011AA)
Women of child-bearing potential must have a negative serum or urine pregnancy test within 2 weeks prior to treatment start
Item
Women of child-bearing potential must have a negative serum or urine pregnancy test within 2 weeks prior to treatment start
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
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)
capable of understanding and complying with protocol requirements, and must be able and willing to sign a written informed consent form
Item
capable of understanding and complying with protocol requirements, and must be able and willing to sign a written informed consent form
boolean
C1273101 (UMLS CUI 2011AA)
395659009 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C1709747 (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)
A history of allergic reactions to egg. A history of allergic reactions of CTCAE grade 3 or 4 to cytarabine
Item
A history of allergic reactions to egg. A history of allergic reactions of CTCAE grade 3 or 4 to cytarabine
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0013710 (UMLS CUI 2011AA)
102263004 (SNOMED CT 2011_0131)
C0010711 (UMLS CUI 2011AA)
89265009 (SNOMED CT 2011_0131)
C1519275 (UMLS CUI 2011AA)
CL427997 (UMLS CUI 2011AA)
Persistent clinically significant toxicities from previous chemotherapy
Item
Persistent clinically significant toxicities from previous chemotherapy
boolean
C0205322 (UMLS CUI 2011AA)
C0040539 (UMLS CUI 2011AA)
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)
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
Item
Pregnant and nursing patients
boolean
C0549206 (UMLS CUI 1)
10036586 (MedDRA 1)
C0006147 (UMLS CUI 2)
10006247 (MedDRA 2)
Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, or psychiatric illness/social situations that would limit compliance with study requirements
Item
Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, or psychiatric illness/social situations that would limit 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)
C0439801 (UMLS CUI 2011AA)
255469002 (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)
Impairment of hepatic or renal function to such an extent that the patient, in the opinion of the investigator, will be exposed to an excessive risk if entered into this clinical study
Item
Impairment of hepatic or renal function to such an extent that the patient, in the opinion of the investigator, will be exposed to an excessive risk if entered into this clinical study
boolean
C0948807 (UMLS CUI 2011AA)
10052254 (MedDRA 14.1)
C0341697 (UMLS CUI 2011AA)
236423003 (SNOMED CT 2011_0131)
10062237 (MedDRA 14.1)
C2348568 (UMLS CUI 2011AA)
C0442802 (UMLS CUI 2011AA)
260378005 (SNOMED CT 2011_0131)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure. Any New York Heart Association (NYHA) functional classification grade 3 or 4
Item
Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure. Any New York Heart Association (NYHA) functional classification grade 3 or 4
boolean
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)
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)
Applicable only for patients for whom an anthracycline is part of the selected control treatment: Left ventricular ejection fraction (LVEF) must be >= 45 % as measured by MUGA scan or 2D ECHO within 14 days prior to start of therapy. Either method is acceptable for measuring LVEF
Item
Applicable only for patients for whom an anthracycline is part of the selected control treatment: Left ventricular ejection fraction (LVEF) must be >= 45 % as measured by MUGA scan or 2D ECHO within 14 days prior to start of therapy. Either method is acceptable for measuring LVEF
boolean
C0750557 (UMLS CUI 2011AA)
C0282564 (UMLS CUI 2011AA)
372540003 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
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)
Applicable only for patients for whom an anthracycline is part of the selected control treatment: The patient should tolerate minimum one course of combination therapy
Item
Applicable only for patients for whom an anthracycline is part of the selected control treatment: The patient should tolerate minimum one course of combination therapy
boolean
C0750557 (UMLS CUI 2011AA)
C0282564 (UMLS CUI 2011AA)
372540003 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C1524031 (UMLS CUI 2011AA)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0750729 (UMLS CUI 2011AA)
288524001 (SNOMED CT 2011_0131)
C0556895 (UMLS CUI 2011AA)
229554006 (SNOMED CT 2011_0131)
any anti-leukaemic agents within the last 3 weeks. Hydroxyurea,however, is allowed for up to 12 hours prior to study treatment
Item
any anti-leukaemic agents within the last 3 weeks. Hydroxyurea,however, is allowed for up to 12 hours prior to study treatment
boolean
C0596112 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0020402 (UMLS CUI 2011AA)
56602009 (SNOMED CT 2011_0131)
CL415096 (UMLS CUI 2011AA)
C0205458 (UMLS CUI 2011AA)
82809009 (SNOMED CT 2011_0131)
C0439227 (UMLS CUI 2011AA)
258702006 (SNOMED CT 2011_0131)
HR, h (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
any investigational treatment within the last 14 days
Item
any investigational treatment within the last 14 days
boolean
C0949266 (UMLS CUI 2011AA)
C1517741 (UMLS CUI 2011AA)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
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)
C1883420 (UMLS CUI 2011AA)
C0332167 (UMLS CUI 2011AA)
15508007 (SNOMED CT 2011_0131)
C0040539 (UMLS CUI 2011AA)