ID

43065

Description

ODM derived from http://clinicaltrials.gov/show/NCT01295307

Link

http://clinicaltrials.gov/show/NCT01295307

Keywords

Versions (3)
  1. 3/19/13 3/19/13 - Martin Dugas
  2. 4/19/14 4/19/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01295307 Acute Myeloid Leukemia

German English

Eligibility

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

Inclusion Criteria

age at least 40 Years
Description

age at least 40 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Diagnosis of AML according to WHO criteria.
Description

Diagnosis of AML according to WHO criteria.

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
Untreated relapse or refractory disease after a minimum of one standard induction therapy. Treatment of relapse with leukocyte-apheresis or up to 5 days with low dose cytarabine or hydroxyurea is allowed.
Description

Untreated relapse or refractory disease after a minimum of one standard induction therapy. Treatment of relapse with leukocyte-apheresis or up to 5 days with low dose cytarabine or hydroxyurea is allowed.

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0277556
SNOMED CT 2011_0131
58184002
UMLS CUI 2011AA
C1514815
UMLS CUI 2011AA
C1524031
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0600558
UMLS CUI 2011AA
C1524004
UMLS CUI 2011AA
C0023416
SNOMED CT 2011_0131
77257005
MedDRA 14.1
10051524
ICD-9-CM Version 2011
99.72
UMLS CUI 2011AA
C0445550
SNOMED CT 2011_0131
262459003
UMLS CUI 2011AA
C0010711
SNOMED CT 2011_0131
89265009
UMLS CUI 2011AA
C0020402
SNOMED CT 2011_0131
56602009
Refractory disease is defined as >=5% blasts after the second cycle of induction therapy or no reduction in marrow blasts at early treatment assessment (day +15) after the first cycle of induction therapy.
Description

Refractory disease is defined as >=5% blasts after the second cycle of induction therapy or no reduction in marrow blasts at early treatment assessment (day +15) after the first cycle of induction therapy.

Data type

boolean

Alias
UMLS CUI 2011AA
C1514815
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205451
SNOMED CT 2011_0131
34001005
UMLS CUI 2011AA
C0439165
SNOMED CT 2011_0131
118582008
UMLS CUI 2011AA
C0368761
SNOMED CT 2011_0131
312256009
LOINC Version 232
MTHU005201
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0392756
SNOMED CT 2011_0131
260400001
UMLS CUI 2011AA
C0005953
SNOMED CT 2011_0131
14016003
LOINC Version 232
MTHU016536
UMLS CUI 2011AA
C0368761
SNOMED CT 2011_0131
312256009
LOINC Version 232
MTHU005201
Relapse is defined as an increase in bone marrow blast count >=5%, re-appearance of blasts in the peripheral blood or extramedullary disease.
Description

Relapse is defined as an increase in bone marrow blast count >=5%, re-appearance of blasts in the peripheral blood or extramedullary disease.

Data type

boolean

Alias
UMLS CUI 2011AA
C0277556
SNOMED CT 2011_0131
58184002
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C0442805
SNOMED CT 2011_0131
260366006
UMLS CUI 2011AA
C0005953
SNOMED CT 2011_0131
14016003
LOINC Version 232
MTHU016536
UMLS CUI 2011AA
C0523113
SNOMED CT 2011_0131
104102000
MedDRA 14.1
10061700
UMLS CUI 2011AA
C0205341
SNOMED CT 2011_0131
27582007
UMLS CUI 2011AA
C0243132
UMLS CUI 2011AA
C0368761
SNOMED CT 2011_0131
312256009
LOINC Version 232
MTHU005201
UMLS CUI 2011AA
C0229664
SNOMED CT 2011_0131
119273009
LOINC Version 232
MTHU003709
UMLS CUI 2011AA
C1517060
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
Have adequate renal and hepatic functions as indicated by the following laboratory values:
Description

Have adequate renal and hepatic functions as indicated by the following laboratory values:

Data type

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0232804
SNOMED CT 2011_0131
11953005
UMLS CUI 2011AA
C0232741
SNOMED CT 2011_0131
79036002
Serum creatinine <=1.0 mg/dL. If serum creatinine >1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be >60 mL/min/1.73 m2 (see reference below*)
Description

Serum creatinine <=1.0 mg/dL. If serum creatinine >1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be >60 mL/min/1.73 m2 (see reference below*)

Data type

boolean

Alias
UMLS CUI 2011AA
C0201976
SNOMED CT 2011_0131
113075003
MedDRA 14.1
10040230
UMLS CUI 2011AA
C0750572
SNOMED CT 2011_0131
414135002
UMLS CUI 2011AA
C0017654
SNOMED CT 2011_0131
80274001
MedDRA 14.1
10018355
Serum bilirubin <=1.5 x upper limit of normal (ULN)
Description

Serum bilirubin <=1.5 x upper limit of normal (ULN)

Data type

boolean

Alias
UMLS CUI 2011AA
C1278039
SNOMED CT 2011_0131
166610007
MedDRA 14.1
10040157
Aspartate transaminase (AST)/alanine transaminase (ALT) <=2.5 x ULN
Description

Aspartate transaminase (AST)/alanine transaminase (ALT) <=2.5 x ULN

Data type

boolean

Alias
UMLS CUI 2011AA
C0004002
SNOMED CT 2011_0131
26091008
LOINC Version 232
MTHU004883
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C1519815
Alkaline phosphatase <=2.5 x ULN
Description

Alkaline phosphatase <=2.5 x ULN

Data type

boolean

Alias
UMLS CUI 2011AA
C0002059
SNOMED CT 2011_0131
57056007
LOINC Version 232
MTHU005195
UMLS CUI 2011AA
C1519815
Eligibility for intensive chemotherapy
Description

Eligibility for intensive chemotherapy

Data type

boolean

Alias
UMLS CUI 2011AA
C1548635
HL7 V3 2006_05
ELG
UMLS CUI 2011AA
C0522510
SNOMED CT 2011_0131
103370009
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
Patient needs to be capable to understand the clinical trial as an investigational approach to bridge the time to potential allogeneic HCT, potential risks and benefits of the study.
Description

Patient needs to be capable to understand the clinical trial as an investigational approach to bridge the time to potential allogeneic HCT, potential risks and benefits of the study.

Data type

boolean

Alias
UMLS CUI 2011AA
C1273101
SNOMED CT 2011_0131
395659009
UMLS CUI 2011AA
C0681832
UMLS CUI 2011AA
C0332149
SNOMED CT 2011_0131
371930009
UMLS CUI 2011AA
C2242529
MedDRA 14.1
10067862
UMLS CUI 2011AA
C0524785
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Signed written informed consent.
Description

Signed written informed consent.

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Female patients of childbearing potential must have a negative serum
Description

Female patients of childbearing potential must have a negative serum

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
CL415098
UMLS CUI 2011AA
C0229671
SNOMED CT 2011_0131
67922002
LOINC Version 232
MTHU001009
Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
Description

Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.

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
Exclusion Criteria
Description

Exclusion Criteria

For refractory disease, more than two prior induction chemotherapies or more than one prior salvage chemotherapy containing high-dose cytarabine (cumulative dose of cytarabine >= 5 g/m2).
Description

For refractory disease, more than two prior induction chemotherapies or more than one prior salvage chemotherapy containing high-dose cytarabine (cumulative dose of cytarabine >= 5 g/m2).

Data type

boolean

Alias
UMLS CUI 2011AA
C1514815
UMLS CUI 2011AA
C0439093
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C3179010
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0085405
MedDRA 14.1
10068833
UMLS CUI 2011AA
C0444956
SNOMED CT 2011_0131
261829003
UMLS CUI 2011AA
C0010711
SNOMED CT 2011_0131
89265009
Second or higher relapse. Patients who received hypomethylating agents like azacytidine or decitabine as a treatment of first relapse, respond and relapse later on may be included.
Description

Second or higher relapse. Patients who received hypomethylating agents like azacytidine or decitabine as a treatment of first relapse, respond and relapse later on may be included.

Data type

boolean

Alias
UMLS CUI 2011AA
C0439093
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0277556
SNOMED CT 2011_0131
58184002
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C1254351
UMLS CUI 2011AA
CL414898
UMLS CUI 2011AA
C2613367
UMLS CUI 2011AA
C0004475
SNOMED CT 2011_0131
412329008
UMLS CUI 2011AA
C0049065
SNOMED CT 2011_0131
420517007
UMLS CUI 2011AA
C0332149
SNOMED CT 2011_0131
371930009
UMLS CUI 2011AA
C1302261
SNOMED CT 2011_0131
399223003
Acute promyelocytic leukemia with t(15;17)(q22;q12) molecular detection or (PML/RARalpha).
Description

Acute promyelocytic leukemia with t(15;17)(q22;q12) molecular detection or (PML/RARalpha).

Data type

boolean

Alias
UMLS CUI 2011AA
C0023487
SNOMED CT 2011_0131
110004001
MedDRA 14.1
10001019
ICD-10-CM Version 2010
C92.4
UMLS CUI 2011AA
C1515724
UMLS CUI 2011AA
CL414625
UMLS CUI 2011AA
C1511790
UMLS CUI 2011AA
C0279625
Central nervous system involvement (i.e. WBC >= 5/microL in cerebrospinal fluid with blasts present on cytospin).
Description

Central nervous system involvement (i.e. WBC >= 5/microL in cerebrospinal fluid with blasts present on cytospin).

Data type

boolean

Alias
UMLS CUI 2011AA
C0449389
SNOMED CT 2011_0131
260766009
UMLS CUI 2011AA
C0023508
SNOMED CT 2011_0131
767002
MedDRA 14.1
10047939
UMLS CUI 2011AA
C1271796
SNOMED CT 2011_0131
391308009
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0368761
SNOMED CT 2011_0131
312256009
LOINC Version 232
MTHU005201
Prior allogeneic HCT
Description

Prior allogeneic HCT

Data type

boolean

Alias
UMLS CUI 2011AA
C2242529
SNOMED CT 2011_0131
288556008
MedDRA 14.1
10067862
Autologous transplantation within 100 days prior to start of study treatment
Description

Autologous transplantation within 100 days prior to start of study treatment

Data type

boolean

Alias
UMLS CUI 2011AA
C0040736
SNOMED CT 2011_0131
53088000
MedDRA 14.1
10064285
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C1704407
SNOMED CT 2011_0131
420528006
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2348558
Use of investigational agents or anticancer therapy within 10 days before study entry with the exception of hydroxyurea or low-dose cytarabine.
Description

Use of investigational agents or anticancer therapy within 10 days before study entry with the exception of hydroxyurea or low-dose cytarabine.

Data type

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C0920425
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0020402
SNOMED CT 2011_0131
56602009
UMLS CUI 2011AA
C0445550
SNOMED CT 2011_0131
262459003
UMLS CUI 2011AA
C0010711
SNOMED CT 2011_0131
89265009
Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo transplantation.
Description

Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo transplantation.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205420
SNOMED CT 2011_0131
68405009
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0349410
SNOMED CT 2011_0131
251526004
UMLS CUI 2011AA
C0018799
SNOMED CT 2011_0131
56265001
MedDRA 14.1
10061024
UMLS CUI 2011AA
C0022658
SNOMED CT 2011_0131
90708001
MedDRA 14.1
10029151
ICD-10-CM Version 2010
N18.9
UMLS CUI 2011AA
C0023895
SNOMED CT 2011_0131
235856003
MedDRA 14.1
10024670
ICD-10-CM Version 2010
K76.9
ICD-9-CM Version 2011
573.9
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0460002
SNOMED CT 2011_0131
91689009
Patients with known refractoriness to platelet support.
Description

Patients with known refractoriness to platelet support.

Data type

boolean

Alias
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C0205269
SNOMED CT 2011_0131
20646008
UMLS CUI 2011AA
C0005821
SNOMED CT 2011_0131
16378004
LOINC Version 232
MTHU002432
UMLS CUI 2011AA
C1521721
Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
Description

Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).

Data type

boolean

Alias
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C0026946
SNOMED CT 2011_0131
3218000
MedDRA 14.1
10017533
ICD-10-CM Version 2010
B35-B49
ICD-9-CM Version 2011
110-118.99
UMLS CUI 2011AA
C0004623
SNOMED CT 2011_0131
87628006
MedDRA 14.1
10060945
ICD-10-CM Version 2010
A49.9
UMLS CUI 2011AA
C0042769
SNOMED CT 2011_0131
34014006
MedDRA 14.1
10047461
ICD-10-CM Version 2010
B34.9
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
Pregnant or lactating patients.
Description

Pregnant or lactating patients.

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C2828358
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
Description

Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205420
SNOMED CT 2011_0131
68405009
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
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
C0221099
SNOMED CT 2011_0131
260379002
UMLS CUI 2011AA
C1113679
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C0525058
UMLS CUI 2011AA
C0459471
SNOMED CT 2011_0131
280452008
LOINC Version 232
MTHU003869
UMLS CUI 2011AA
C0683954
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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
age at least 40 Years
Item
age at least 40 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Diagnosis of AML according to WHO criteria.
Item
Diagnosis of AML according to WHO criteria.
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)
Untreated relapse or refractory disease after a minimum of one standard induction therapy. Treatment of relapse with leukocyte-apheresis or up to 5 days with low dose cytarabine or hydroxyurea is allowed.
Item
Untreated relapse or refractory disease after a minimum of one standard induction therapy. Treatment of relapse with leukocyte-apheresis or up to 5 days with low dose cytarabine or hydroxyurea is allowed.
boolean
C1518422 (UMLS CUI 2011AA)
CL415147 (UMLS CUI 2011AA)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C1514815 (UMLS CUI 2011AA)
C1524031 (UMLS CUI 2011AA)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0600558 (UMLS CUI 2011AA)
C1524004 (UMLS CUI 2011AA)
C0023416 (UMLS CUI 2011AA)
77257005 (SNOMED CT 2011_0131)
10051524 (MedDRA 14.1)
99.72 (ICD-9-CM Version 2011)
C0445550 (UMLS CUI 2011AA)
262459003 (SNOMED CT 2011_0131)
C0010711 (UMLS CUI 2011AA)
89265009 (SNOMED CT 2011_0131)
C0020402 (UMLS CUI 2011AA)
56602009 (SNOMED CT 2011_0131)
Refractory disease is defined as >=5% blasts after the second cycle of induction therapy or no reduction in marrow blasts at early treatment assessment (day +15) after the first cycle of induction therapy.
Item
Refractory disease is defined as >=5% blasts after the second cycle of induction therapy or no reduction in marrow blasts at early treatment assessment (day +15) after the first cycle of induction therapy.
boolean
C1514815 (UMLS CUI 2011AA)
C1704788 (UMLS CUI 2011AA)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205451 (UMLS CUI 2011AA)
34001005 (SNOMED CT 2011_0131)
C0439165 (UMLS CUI 2011AA)
118582008 (SNOMED CT 2011_0131)
C0368761 (UMLS CUI 2011AA)
312256009 (SNOMED CT 2011_0131)
MTHU005201 (LOINC Version 232)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0392756 (UMLS CUI 2011AA)
260400001 (SNOMED CT 2011_0131)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C0368761 (UMLS CUI 2011AA)
312256009 (SNOMED CT 2011_0131)
MTHU005201 (LOINC Version 232)
Relapse is defined as an increase in bone marrow blast count >=5%, re-appearance of blasts in the peripheral blood or extramedullary disease.
Item
Relapse is defined as an increase in bone marrow blast count >=5%, re-appearance of blasts in the peripheral blood or extramedullary disease.
boolean
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C1704788 (UMLS CUI 2011AA)
C0442805 (UMLS CUI 2011AA)
260366006 (SNOMED CT 2011_0131)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C0523113 (UMLS CUI 2011AA)
104102000 (SNOMED CT 2011_0131)
10061700 (MedDRA 14.1)
C0205341 (UMLS CUI 2011AA)
27582007 (SNOMED CT 2011_0131)
C0243132 (UMLS CUI 2011AA)
C0368761 (UMLS CUI 2011AA)
312256009 (SNOMED CT 2011_0131)
MTHU005201 (LOINC Version 232)
C0229664 (UMLS CUI 2011AA)
119273009 (SNOMED CT 2011_0131)
MTHU003709 (LOINC Version 232)
C1517060 (UMLS CUI 2011AA)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
Have adequate renal and hepatic functions as indicated by the following laboratory values:
Item
Have adequate renal and hepatic functions as indicated by the following laboratory values:
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
C0232741 (UMLS CUI 2011AA)
79036002 (SNOMED CT 2011_0131)
Serum creatinine <=1.0 mg/dL. If serum creatinine >1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be >60 mL/min/1.73 m2 (see reference below*)
Item
Serum creatinine <=1.0 mg/dL. If serum creatinine >1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be >60 mL/min/1.73 m2 (see reference below*)
boolean
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C0750572 (UMLS CUI 2011AA)
414135002 (SNOMED CT 2011_0131)
C0017654 (UMLS CUI 2011AA)
80274001 (SNOMED CT 2011_0131)
10018355 (MedDRA 14.1)
Serum bilirubin <=1.5 x upper limit of normal (ULN)
Item
Serum bilirubin <=1.5 x upper limit of normal (ULN)
boolean
C1278039 (UMLS CUI 2011AA)
166610007 (SNOMED CT 2011_0131)
10040157 (MedDRA 14.1)
Aspartate transaminase (AST)/alanine transaminase (ALT) <=2.5 x ULN
Item
Aspartate transaminase (AST)/alanine transaminase (ALT) <=2.5 x ULN
boolean
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
Alkaline phosphatase <=2.5 x ULN
Item
Alkaline phosphatase <=2.5 x ULN
boolean
C0002059 (UMLS CUI 2011AA)
57056007 (SNOMED CT 2011_0131)
MTHU005195 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
Eligibility for intensive chemotherapy
Item
Eligibility for intensive chemotherapy
boolean
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
C0522510 (UMLS CUI 2011AA)
103370009 (SNOMED CT 2011_0131)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
Patient needs to be capable to understand the clinical trial as an investigational approach to bridge the time to potential allogeneic HCT, potential risks and benefits of the study.
Item
Patient needs to be capable to understand the clinical trial as an investigational approach to bridge the time to potential allogeneic HCT, potential risks and benefits of the study.
boolean
C1273101 (UMLS CUI 2011AA)
395659009 (SNOMED CT 2011_0131)
C0681832 (UMLS CUI 2011AA)
C0332149 (UMLS CUI 2011AA)
371930009 (SNOMED CT 2011_0131)
C2242529 (UMLS CUI 2011AA)
10067862 (MedDRA 14.1)
C0524785 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Signed written informed consent.
Item
Signed written informed consent.
boolean
C0021430 (UMLS CUI 2011AA)
Female patients of childbearing potential must have a negative serum
Item
Female patients of childbearing potential must have a negative serum
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
CL415098 (UMLS CUI 2011AA)
C0229671 (UMLS CUI 2011AA)
67922002 (SNOMED CT 2011_0131)
MTHU001009 (LOINC Version 232)
Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
Item
Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
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)
Item Group
Exclusion Criteria
For refractory disease, more than two prior induction chemotherapies or more than one prior salvage chemotherapy containing high-dose cytarabine (cumulative dose of cytarabine >= 5 g/m2).
Item
For refractory disease, more than two prior induction chemotherapies or more than one prior salvage chemotherapy containing high-dose cytarabine (cumulative dose of cytarabine >= 5 g/m2).
boolean
C1514815 (UMLS CUI 2011AA)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C3179010 (UMLS CUI 2011AA)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0085405 (UMLS CUI 2011AA)
10068833 (MedDRA 14.1)
C0444956 (UMLS CUI 2011AA)
261829003 (SNOMED CT 2011_0131)
C0010711 (UMLS CUI 2011AA)
89265009 (SNOMED CT 2011_0131)
Second or higher relapse. Patients who received hypomethylating agents like azacytidine or decitabine as a treatment of first relapse, respond and relapse later on may be included.
Item
Second or higher relapse. Patients who received hypomethylating agents like azacytidine or decitabine as a treatment of first relapse, respond and relapse later on may be included.
boolean
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C1254351 (UMLS CUI 2011AA)
CL414898 (UMLS CUI 2011AA)
C2613367 (UMLS CUI 2011AA)
C0004475 (UMLS CUI 2011AA)
412329008 (SNOMED CT 2011_0131)
C0049065 (UMLS CUI 2011AA)
420517007 (SNOMED CT 2011_0131)
C0332149 (UMLS CUI 2011AA)
371930009 (SNOMED CT 2011_0131)
C1302261 (UMLS CUI 2011AA)
399223003 (SNOMED CT 2011_0131)
Acute promyelocytic leukemia with t(15;17)(q22;q12) molecular detection or (PML/RARalpha).
Item
Acute promyelocytic leukemia with t(15;17)(q22;q12) molecular detection or (PML/RARalpha).
boolean
C0023487 (UMLS CUI 2011AA)
110004001 (SNOMED CT 2011_0131)
10001019 (MedDRA 14.1)
C92.4 (ICD-10-CM Version 2010)
C1515724 (UMLS CUI 2011AA)
CL414625 (UMLS CUI 2011AA)
C1511790 (UMLS CUI 2011AA)
C0279625 (UMLS CUI 2011AA)
Central nervous system involvement (i.e. WBC >= 5/microL in cerebrospinal fluid with blasts present on cytospin).
Item
Central nervous system involvement (i.e. WBC >= 5/microL in cerebrospinal fluid with blasts present on cytospin).
boolean
C0449389 (UMLS CUI 2011AA)
260766009 (SNOMED CT 2011_0131)
C0023508 (UMLS CUI 2011AA)
767002 (SNOMED CT 2011_0131)
10047939 (MedDRA 14.1)
C1271796 (UMLS CUI 2011AA)
391308009 (SNOMED CT 2011_0131)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0368761 (UMLS CUI 2011AA)
312256009 (SNOMED CT 2011_0131)
MTHU005201 (LOINC Version 232)
Prior allogeneic HCT
Item
Prior allogeneic HCT
boolean
C2242529 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
10067862 (MedDRA 14.1)
Autologous transplantation within 100 days prior to start of study treatment
Item
Autologous transplantation within 100 days prior to start of study treatment
boolean
C0040736 (UMLS CUI 2011AA)
53088000 (SNOMED CT 2011_0131)
10064285 (MedDRA 14.1)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C1704407 (UMLS CUI 2011AA)
420528006 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
Use of investigational agents or anticancer therapy within 10 days before study entry with the exception of hydroxyurea or low-dose cytarabine.
Item
Use of investigational agents or anticancer therapy within 10 days before study entry with the exception of hydroxyurea or low-dose cytarabine.
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C0920425 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0020402 (UMLS CUI 2011AA)
56602009 (SNOMED CT 2011_0131)
C0445550 (UMLS CUI 2011AA)
262459003 (SNOMED CT 2011_0131)
C0010711 (UMLS CUI 2011AA)
89265009 (SNOMED CT 2011_0131)
Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo transplantation.
Item
Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo transplantation.
boolean
C0205420 (UMLS CUI 2011AA)
68405009 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0349410 (UMLS CUI 2011AA)
251526004 (SNOMED CT 2011_0131)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
C0022658 (UMLS CUI 2011AA)
90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0460002 (UMLS CUI 2011AA)
91689009 (SNOMED CT 2011_0131)
Patients with known refractoriness to platelet support.
Item
Patients with known refractoriness to platelet support.
boolean
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C0205269 (UMLS CUI 2011AA)
20646008 (SNOMED CT 2011_0131)
C0005821 (UMLS CUI 2011AA)
16378004 (SNOMED CT 2011_0131)
MTHU002432 (LOINC Version 232)
C1521721 (UMLS CUI 2011AA)
Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
Item
Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
boolean
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0026946 (UMLS CUI 2011AA)
3218000 (SNOMED CT 2011_0131)
10017533 (MedDRA 14.1)
B35-B49 (ICD-10-CM Version 2010)
110-118.99 (ICD-9-CM Version 2011)
C0004623 (UMLS CUI 2011AA)
87628006 (SNOMED CT 2011_0131)
10060945 (MedDRA 14.1)
A49.9 (ICD-10-CM Version 2010)
C0042769 (UMLS CUI 2011AA)
34014006 (SNOMED CT 2011_0131)
10047461 (MedDRA 14.1)
B34.9 (ICD-10-CM Version 2010)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
Pregnant or lactating patients.
Item
Pregnant or lactating patients.
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C2828358 (UMLS CUI 2011AA)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
Item
Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
boolean
C0205420 (UMLS CUI 2011AA)
68405009 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
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)
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C1113679 (UMLS CUI 2011AA)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0525058 (UMLS CUI 2011AA)
C0459471 (UMLS CUI 2011AA)
280452008 (SNOMED CT 2011_0131)
MTHU003869 (LOINC Version 232)
C0683954 (UMLS CUI 2011AA)
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