ID
5123
Beskrivning
ODM derived from http://clinicaltrials.gov/show/NCT01295307
Länk
http://clinicaltrials.gov/show/NCT01295307
Nyckelord
Versioner (3)
- 2013-03-19 2013-03-19 - Martin Dugas
- 2014-04-19 2014-04-19 - Julian Varghese
- 2021-09-20 2021-09-20 -
Uppladdad den
19 april 2014
DOI
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Licens
Creative Commons BY 4.0
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Eligibility NCT01295307 Acute Myeloid Leukemia
Eligibility
- StudyEvent: Eligibility
Beskrivning
Ausschlusskriterien
Beskrivning
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).
Datatyp
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
Beskrivning
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.
Datatyp
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
Beskrivning
Acute promyelocytic leukemia with t(15;17)(q22;q12) molecular detection or (PML/RARalpha).
Datatyp
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
Beskrivning
Central nervous system involvement (i.e. WBC >= 5/microL in cerebrospinal fluid with blasts present on cytospin).
Datatyp
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
Beskrivning
Prior allogeneic HCT
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C2242529
- SNOMED CT 2011_0131
- 288556008
- MedDRA 14.1
- 10067862
Beskrivning
Autologous transplantation within 100 days prior to start of study treatment
Datatyp
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
Beskrivning
Use of investigational agents or anticancer therapy within 10 days before study entry with the exception of hydroxyurea or low-dose cytarabine.
Datatyp
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
Beskrivning
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.
Datatyp
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
Beskrivning
Patients with known refractoriness to platelet support.
Datatyp
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
Beskrivning
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).
Datatyp
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
- C0021311
- SNOMED CT 2011_0131
- 257551009
- MedDRA 14.1
- 10021789
Beskrivning
Pregnant or lactating patients.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C2828358
- UMLS CUI 2011AA
- C0030705
- SNOMED CT 2011_0131
- 116154003
Beskrivning
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.
Datatyp
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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Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
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MTHU008876 (LOINC Version 232)
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312256009 (SNOMED CT 2011_0131)
MTHU005201 (LOINC Version 232)
C0229664 (UMLS CUI 2011AA)
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C1517060 (UMLS CUI 2011AA)
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150415003 (SNOMED CT 2011_0131)
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)
248152002 (SNOMED CT 2011_0131)
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260676000 (SNOMED CT 2011_0131)
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89265009 (SNOMED CT 2011_0131)
68405009 (SNOMED CT 2011_0131)
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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)
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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)
116154003 (SNOMED CT 2011_0131)
C0205269 (UMLS CUI 2011AA)
20646008 (SNOMED CT 2011_0131)
C0005821 (UMLS CUI 2011AA)
16378004 (SNOMED CT 2011_0131)
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31099001 (SNOMED CT 2011_0131)
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10017533 (MedDRA 14.1)
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10021789 (MedDRA 14.1)
10036586 (MedDRA 14.1)
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116154003 (SNOMED CT 2011_0131)
68405009 (SNOMED CT 2011_0131)
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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)
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C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
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