ID

44600

Description

ODM derived from http://clinicaltrials.gov/show/NCT01035502

Link

http://clinicaltrials.gov/show/NCT01035502

Keywords

Versions (3)
  1. 12/7/13 12/7/13 - Martin Dugas
  2. 4/17/14 4/17/14 - Julian Varghese
  3. 9/27/21 9/27/21 -
Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01035502 Acute Myeloid Leukemia

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Patients with a confirmed diagnosis of AML according to WHO classification (excluding acute promyelocytic leukaemia)
Description

Patients with a confirmed diagnosis of AML according to WHO classification (excluding acute promyelocytic leukaemia)

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0023467
SNOMED CT 2011_0131
91861009
MedDRA 14.1
10000880
ICD-10-CM Version 2010
C92.0
ICD-9-CM Version 2011
205.0
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C0451584
SNOMED CT 2011_0131
273931002
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0023487
SNOMED CT 2011_0131
110004001
MedDRA 14.1
10001019
ICD-10-CM Version 2010
C92.4
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).
Description

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).

Data type

boolean

Alias
UMLS CUI 2011AA
C2828392
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0010711
SNOMED CT 2011_0131
89265009
UMLS CUI 2011AA
C0205263
SNOMED CT 2011_0131
16404004
UMLS CUI 2011AA
C0677874
SNOMED CT 2011_0131
103338009
UMLS CUI 2011AA
C0543478
SNOMED CT 2011_0131
17964000
UMLS CUI 2011AA
C0175630
SNOMED CT 2011_0131
65929005
UMLS CUI 2011AA
C0368761
SNOMED CT 2011_0131
312256009
LOINC Version 232
MTHU005201
UMLS CUI 2011AA
C0205322
UMLS CUI 2011AA
CL414320
SNOMED CT 2011_0131
188737002, 94719007
MedDRA 14.1
10008583
ICD-9-CM Version 2011
205.3
Patients from whom samples for determination of hENT1 status on leukemic blast cells can be taken and prepared at diagnosis and/or at baseline
Description

Patients from whom samples for determination of hENT1 status on leukemic blast cells can be taken and prepared at diagnosis and/or at baseline

Data type

boolean

Alias
UMLS CUI 2011AA
CL423120
UMLS CUI 2011AA
C1148554
UMLS CUI 2011AA
C1130454
UMLS CUI 2011AA
C0449438
SNOMED CT 2011_0131
263490005
LOINC Version 232
MTHU015827
UMLS CUI 2011AA
C2697913
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1442488
Patients must have ECOG performance status (PS) of 0 - 2
Description

Patients must have ECOG performance status (PS) of 0 - 2

Data type

boolean

Alias
UMLS CUI 2011AA
C1520224
Left ventricular ejection fraction (LVEF) must be >= 45 % as measured by MUGA scan or 2D ECHO within 14 days prior to start of therapy.
Description

Left ventricular ejection fraction (LVEF) must be >= 45 % as measured by MUGA scan or 2D ECHO within 14 days prior to start of therapy.

Data type

boolean

Alias
UMLS CUI 2011AA
C0428772
SNOMED CT 2011_0131
250908004
MedDRA 14.1
10069170
UMLS CUI 2011AA
C0521317
SNOMED CT 2011_0131
404221001
MedDRA 14.1
10028211
UMLS CUI 2011AA
C0013524
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
Description

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

Data type

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0279752
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0543467
SNOMED CT 2011_0131
83578000
MedDRA 14.1
10051332
LOINC Version 232
MTHU000079
UMLS CUI 2011AA
C0021359
SNOMED CT 2011_0131
8619003
MedDRA 14.1
10021926
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C0430061
SNOMED CT 2011_0131
166435006
UMLS CUI 2011AA
C0430057
SNOMED CT 2011_0131
167254001
MedDRA 14.1
10036577
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
Description

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

Data type

boolean

Alias
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C1707141
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
Description

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

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Patients must have the following clinical laboratory values:
Description

Patients must have the following clinical laboratory values:

Data type

boolean

Alias
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C0022877
SNOMED CT 2011_0131
261904005
LOINC Version 232
MTHU029808
UMLS CUI 2011AA
C1522609
Serum creatinine <= 1.5 x the institutional upper limit of normal (ULN)
Description

Serum creatinine <= 1.5 x the institutional upper limit of normal (ULN)

Data type

boolean

Alias
UMLS CUI 2011AA
C0201976
Total bilirubin <= 1.5 x the ULN according to national prescribing information unless considered due to Gilbert's syndrome
Description

Total bilirubin <= 1.5 x the ULN according to national prescribing information unless considered due to Gilbert's syndrome

Data type

boolean

Alias
UMLS CUI 2011AA
C0201913
SNOMED CT 2011_0131
359986008
MedDRA 14.1
10004696
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
CL415062
UMLS CUI 2011AA
C0033080
SNOMED CT 2011_0131
16076005
UMLS CUI 2011AA
CL414911
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0017551
SNOMED CT 2011_0131
27503000
MedDRA 14.1
10018267
ICD-10-CM Version 2010
E80.4
Alanine aminotransferase (ALT) (SGPT), or aspartate aminotransferase (AST) (SGOT) <= 2.5 x the ULN unless considered due to organ leukemic involvement
Description

Alanine aminotransferase (ALT) (SGPT), or aspartate aminotransferase (AST) (SGOT) <= 2.5 x the ULN unless considered due to organ leukemic involvement

Data type

boolean

Alias
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C0004002
SNOMED CT 2011_0131
26091008
LOINC Version 232
MTHU004883
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0178784
LOINC Version 232
MTHU020170
UMLS CUI 2011AA
C0023418
SNOMED CT 2011_0131
93143009
MedDRA 14.1
10024288
ICD-10-CM Version 2010
C95.9
ICD-9-CM Version 2011
208.9
UMLS CUI 2011AA
C1314939
SNOMED CT 2011_0131
248448006
Patients must be eligible for administration of idarubicin according to current national prescribing information for idarubicin
Description

Patients must be eligible for administration of idarubicin according to current national prescribing information for idarubicin

Data type

boolean

Alias
UMLS CUI 2011AA
C1548635
HL7 V3 2006_05
ELG
UMLS CUI 2011AA
C1533734
SNOMED CT 2011_0131
416118004
UMLS CUI 2011AA
C0020789
SNOMED CT 2011_0131
372539000
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
CL415062
UMLS CUI 2011AA
C0033080
SNOMED CT 2011_0131
16076005
UMLS CUI 2011AA
CL414911
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
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
Description

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

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C1527304
SNOMED CT 2011_0131
421668005
MedDRA 14.1
10001718
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0013710
SNOMED CT 2011_0131
102263004
UMLS CUI 2011AA
C0020789
SNOMED CT 2011_0131
372539000
UMLS CUI 2011AA
C0282564
SNOMED CT 2011_0131
372540003
UMLS CUI 2011AA
C0010711
SNOMED CT 2011_0131
89265009
UMLS CUI 2011AA
C1519275
UMLS CUI 2011AA
CL427997
Persistent clinically significant and relevant toxicities from the previous course of chemotherapy
Description

Persistent clinically significant and relevant toxicities from the previous course of chemotherapy

Data type

boolean

Alias
UMLS CUI 2011AA
C0205322
UMLS CUI 2011AA
C0040539
UMLS CUI 2011AA
C1314792
SNOMED CT 2011_0131
134198009
UMLS CUI 2011AA
C1514457
A cancer history, that according to the investigator might confound the assessment of the study endpoints
Description

A cancer history, that according to the investigator might confound the assessment of the study endpoints

Data type

boolean

Alias
UMLS CUI 2011AA
C2735088
LOINC Version 232
MTHU034770
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C1516048
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C2349179
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
Description

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

Data type

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
CL426125
UMLS CUI 2011AA
C0013089
SNOMED CT 2011_0131
68444001
LOINC Version 232
MTHU004184
UMLS CUI 2011AA
CL415123
UMLS CUI 2011AA
C1441506
UMLS CUI 2011AA
C0918012
UMLS CUI 2011AA
C0026259
SNOMED CT 2011_0131
386913001
UMLS CUI 2011AA
C0220845
UMLS CUI 2011AA
C1709515
UMLS CUI 2011AA
C0020789
SNOMED CT 2011_0131
372539000
UMLS CUI 2011AA
C0556895
SNOMED CT 2011_0131
229554006
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
Description

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

Data type

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0018799
SNOMED CT 2011_0131
56265001
MedDRA 14.1
10061024
ICD-10-CM Version 2010
I51.9
ICD-9-CM Version 2011
429.9
UMLS CUI 2011AA
C0027051
SNOMED CT 2011_0131
22298006
MedDRA 14.1
10028596
LOINC Version 232
MTHU035551
ICD-10-CM Version 2010
I21-I22
ICD-9-CM Version 2011
410
CTCAE 1105E
E10152
UMLS CUI 2011AA
C0231220
SNOMED CT 2011_0131
264931009
UMLS CUI 2011AA
C0010068
SNOMED CT 2011_0131
53741008
MedDRA 14.1
10068617
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0003811
SNOMED CT 2011_0131
44808001
MedDRA 14.1
10003119
ICD-9-CM Version 2011
427.9
UMLS CUI 2011AA
C0018802
SNOMED CT 2011_0131
42343007
MedDRA 14.1
10007559
LOINC Version 232
MTHU020787
ICD-10-CM Version 2010
I50.9
ICD-9-CM Version 2011
428.0
UMLS CUI 2011AA
C1319795
SNOMED CT 2011_0131
420913000
MedDRA 14.1
10064081
UMLS CUI 2011AA
C1319796
SNOMED CT 2011_0131
422293003
MedDRA 14.1
10064082
HIV Seropositivity
Description

Known positive status for human immunodeficiency virus (HIV)

Data type

boolean

Alias
UMLS CUI 2011AA
C0019699
SNOMED CT 2011_0131
165816005
MedDRA 14.1
10020188
ICD-10-CM Version 2010
Z21
Pregnant and nursing patients are excluded because the effects of elacytarabine on a fetus or a nursing child are unknown
Description

Pregnant and nursing patients are excluded because the effects of elacytarabine on a fetus or a nursing child are unknown

Data type

boolean

Alias
UMLS CUI 1
C0549206
MedDRA 1
10036586
UMLS CUI 2
C0006147
MedDRA 2
10006247
Uncontrolled intercurrent illness including, but not limited to uncontrolled infection, or psychiatric illness/social situations that may reduce compliance with study requirements
Description

Uncontrolled intercurrent illness including, but not limited to uncontrolled infection, or psychiatric illness/social situations that may reduce compliance with study requirements

Data type

boolean

Alias
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0277557
SNOMED CT 2011_0131
88472004
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0004936
SNOMED CT 2011_0131
74732009
MedDRA 14.1
10037174
ICD-10-CM Version 2010
F99
ICD-9-CM Version 2011
290-319.99
UMLS CUI 2011AA
C0851364
MedDRA 14.1
10041244
UMLS CUI 2011AA
C0392756
SNOMED CT 2011_0131
260400001
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1514873
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
Description

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

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0020402
SNOMED CT 2011_0131
56602009
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0677881
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C1514832
Any medical condition, which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities
Description

Any medical condition, which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities

Data type

boolean

Alias
UMLS CUI 2011AA
C1699700
HL7 V3 2006_05
MEDCCAT
UMLS CUI 2011AA
C0332167
SNOMED CT 2011_0131
15508007
UMLS CUI 2011AA
C0040539
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
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
C1520224 (UMLS CUI 2011AA)
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
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0086287 (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
C0021430 (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)
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)
Item Group
Exclusion Criteria
CL425201 (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 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 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)
C0009450 (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)
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