ID
43377
Descripción
ODM derived from http://clinicaltrials.gov/show/NCT00560794
Link
http://clinicaltrials.gov/show/NCT00560794
Palabras clave
Versiones (3)
- 10/12/13 10/12/13 - Martin Dugas
- 14/4/14 14/4/14 - Julian Varghese
- 20/9/21 20/9/21 -
Subido en
20 de septiembre de 2021
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY 4.0
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Eligibility NCT00560794 Acute Lymphoblastic Leukemia
Eligibility
- StudyEvent: Eligibility
Descripción
Exclusion Criteria
Alias
- UMLS CUI 2011AA
- CL425201
Descripción
Current extra medullar involvement
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0521116
- SNOMED CT 2011_0131
- 15240007
- UMLS CUI 2011AA
- C1517060
- UMLS CUI 2011AA
- C1314939
- SNOMED CT 2011_0131
- 248448006
Descripción
History of or current relevant CNS pathology (except migraine/headache and/or previous infiltration of cerebrospinal fluid (CSF) by ALL)
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0521116
- SNOMED CT 2011_0131
- 15240007
- UMLS CUI 2011AA
- C2347946
- UMLS CUI 2011AA
- C0007682
- SNOMED CT 2011_0131
- 23853001
- MedDRA 14.1
- 10007943
- ICD-10-CM Version 2010
- G96.9
- UMLS CUI 2011AA
- C1554961
- HL7 V3 2006_05
- E
- UMLS CUI 2011AA
- C0149931
- SNOMED CT 2011_0131
- 37796009
- MedDRA 14.1
- 10027599
- ICD-10-CM Version 2010
- G43
- ICD-9-CM Version 2011
- 346
- UMLS CUI 2011AA
- C0018681
- SNOMED CT 2011_0131
- 25064002
- MedDRA 14.1
- 10019211
- LOINC Version 232
- MTHU020860
- ICD-10-CM Version 2010
- R51
- ICD-9-CM Version 2011
- 784.0
- CTCAE 1105E
- E12678
- UMLS CUI 2011AA
- C0205156
- SNOMED CT 2011_0131
- 9130008
- UMLS CUI 2011AA
- C0332448
- SNOMED CT 2011_0131
- 47351003
- UMLS CUI 2011AA
- C0007806
- SNOMED CT 2011_0131
- 65216001
- LOINC Version 232
- MTHU001311
- HL7 V3 2006_05
- CSF
- UMLS CUI 2011AA
- C0023449
- SNOMED CT 2011_0131
- 91857003, 128822004
- MedDRA 14.1
- 10060390
- ICD-10-CM Version 2010
- C91.0
- ICD-9-CM Version 2011
- 204.0
Descripción
Current infiltration of cerebrospinal fluid by ALL
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0521116
- SNOMED CT 2011_0131
- 15240007
- UMLS CUI 2011AA
- C0332448
- SNOMED CT 2011_0131
- 47351003
- UMLS CUI 2011AA
- C0007806
- SNOMED CT 2011_0131
- 65216001
- LOINC Version 232
- MTHU001311
- HL7 V3 2006_05
- CSF
- UMLS CUI 2011AA
- C0023449
- SNOMED CT 2011_0131
- 91857003, 128822004
- MedDRA 14.1
- 10060390
- ICD-10-CM Version 2010
- C91.0
- ICD-9-CM Version 2011
- 204.0
Descripción
History of or current autoimmune disease
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0521116
- SNOMED CT 2011_0131
- 15240007
- UMLS CUI 2011AA
- C0004364
- SNOMED CT 2011_0131
- 85828009
- MedDRA 14.1
- 10061664
- ICD-10-CM Version 2010
- M30-M36
- CTCAE 1105E
- E11258
Descripción
Autologous stem cell transplantation within 6 weeks prior to study entry
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1831743
- UMLS CUI 2011AA
- C0439230
- SNOMED CT 2011_0131
- 258705008
- HL7 V3 2006_05
- WK
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C2348558
Descripción
Any prior allogeneic stem cell transplantation
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C2242529
Descripción
Cancer chemotherapy within 4 weeks prior to study treatment (except for intrathecal prophylaxis and/or low dose maintenance therapy such as vincalkaloids, mercaptopurine, methotrexate, steroids)
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0392920
- SNOMED CT 2011_0131
- 150415003
- UMLS CUI 2011AA
- C0439230
- SNOMED CT 2011_0131
- 258705008
- HL7 V3 2006_05
- WK
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C1554961
- HL7 V3 2006_05
- E
- UMLS CUI 2011AA
- C0205527
- SNOMED CT 2011_0131
- 72607000
- UMLS CUI 2011AA
- C0199176
- SNOMED CT 2011_0131
- 360271000
- MedDRA 14.1
- 10036898
- UMLS CUI 2011AA
- C1708745
- UMLS CUI 2011AA
- C0677908
- SNOMED CT 2011_0131
- 314122007
- UMLS CUI 2011AA
- C0042672
- SNOMED CT 2011_0131
- 61864009
- UMLS CUI 2011AA
- C0000618
- SNOMED CT 2011_0131
- 386835005
- LOINC Version 232
- MTHU002562
- UMLS CUI 2011AA
- C0025677
- SNOMED CT 2011_0131
- 387381009
- LOINC Version 232
- MTHU005020
- UMLS CUI 2011AA
- C0038317
- SNOMED CT 2011_0131
- 116566001
Descripción
Radiotherapy within 4 weeks prior to study treatment
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0034619
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- HL7 V3 2006_05
- MO
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0039798
Descripción
Therapy with monoclonal antibodies (Rituximab, MabCampath) within 6 weeks prior to study treatment
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0003250
- SNOMED CT 2011_0131
- 49616005
- UMLS CUI 2011AA
- C0732355
- SNOMED CT 2011_0131
- 386919002
- UMLS CUI 2011AA
- C0383429
- SNOMED CT 2011_0131
- 391864003
- UMLS CUI 2011AA
- C0439230
- SNOMED CT 2011_0131
- 258705008
- HL7 V3 2006_05
- WK
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0039798
Descripción
Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0205309
- SNOMED CT 2011_0131
- 36692007
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 418634005
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C0021027
- SNOMED CT 2011_0131
- 399771004
- HL7 V3 2006_05
- 14
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C1705248
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C1705957
Descripción
Presence of human anti-murine antibodies (HAMA)
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0150312
- SNOMED CT 2011_0131
- 52101004
- UMLS CUI 2011AA
- C1291910
- SNOMED CT 2011_0131
- 115628002
- LOINC Version 232
- MTHU003865
Descripción
Abnormal bone marrow, renal or hepatic function
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0205161
- SNOMED CT 2011_0131
- 263654008
- UMLS CUI 2011AA
- C0005953
- SNOMED CT 2011_0131
- 14016003
- LOINC Version 232
- MTHU016536
- UMLS CUI 2011AA
- C0151746
- SNOMED CT 2011_0131
- 39539005
- MedDRA 14.1
- 10013902
- UMLS CUI 2011AA
- C0086565
- SNOMED CT 2011_0131
- 75183008
- MedDRA 14.1
- 10019670
Descripción
Indication for a hypercoagulative state
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- CL335836
- UMLS CUI 2011AA
- C0398623
- MedDRA 14.1
- 10020608
Descripción
History of malignancy other than ALL within 5 years prior to study entry, with the exception of basal cell carcinoma of the skin or cervix carcinoma in situ
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0006826
- SNOMED CT 2011_0131
- 363346000
- MedDRA 14.1
- 10028997
- LOINC Version 232
- MTHU010328
- ICD-10-CM Version 2010
- C00-C96
- UMLS CUI 2011AA
- CL411789
- UMLS CUI 2011AA
- C0023449
- SNOMED CT 2011_0131
- 91857003, 128822004
- MedDRA 14.1
- 10060390
- ICD-10-CM Version 2010
- C91.0
- ICD-9-CM Version 2011
- 204.0
- UMLS CUI 2011AA
- C0439234
- SNOMED CT 2011_0131
- 258707000
- HL7 V3 2006_05
- Y
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C2348558
- UMLS CUI 2011AA
- C1554961
- HL7 V3 2006_05
- E
- UMLS CUI 2011AA
- C0007117
- SNOMED CT 2011_0131
- 1338007
- MedDRA 14.1
- 10004146
- UMLS CUI 2011AA
- C0851140
- SNOMED CT 2011_0131
- 92564006
- MedDRA 14.1
- 10061809
- ICD-10-CM Version 2010
- D06.9
- ICD-9-CM Version 2011
- 233.1
Descripción
Active severe infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0205082
- SNOMED CT 2011_0131
- 24484000
- UMLS CUI 2011AA
- C0009450
- SNOMED CT 2011_0131
- 257551009
- MedDRA 14.1
- 10021789
- UMLS CUI 2011AA
- C0205420
- SNOMED CT 2011_0131
- 68405009
- UMLS CUI 2011AA
- C0012634
- SNOMED CT 2011_0131
- 64572001
- UMLS CUI 2011AA
- C1699700
- HL7 V3 2006_05
- MEDCCAT
- UMLS CUI 2011AA
- C0521102
- SNOMED CT 2011_0131
- 78235001
- UMLS CUI 2011AA
- C0750729
- SNOMED CT 2011_0131
- 288524001
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0022423
- SNOMED CT 2011_0131
- 61254005
- UMLS CUI 2011AA
- CL102947
Descripción
Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti-HCV positive
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0205309
- SNOMED CT 2011_0131
- 36692007
- UMLS CUI 2011AA
- C0019693
- SNOMED CT 2011_0131
- 86406008
- MedDRA 14.1
- 10020161
- LOINC Version 232
- MTHU020829
- ICD-10-CM Version 2010
- B20
- ICD-9-CM Version 2011
- 042
- UMLS CUI 2011AA
- C0151317
- SNOMED CT 2011_0131
- 177010002
- UMLS CUI 2011AA
- C0019169
- SNOMED CT 2011_0131
- 81665004
- UMLS CUI 2011AA
- C0149709
- SNOMED CT 2011_0131
- 165806002
- MedDRA 14.1
- 10019742
- UMLS CUI 2011AA
- C0220847
- SNOMED CT 2011_0131
- 62944002
- MedDRA 14.1
- 10019752
- UMLS CUI 2011AA
- C0281863
- MedDRA 14.1
- 10019747
Descripción
Pregnant or nursing women
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0043210
- SNOMED CT 2011_0131
- 224526002
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C0006147
- MedDRA 14.1
- 10006247
Descripción
Women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter or male patients not willing to ensure effective contraception dur-ing participation in the study and at least three months thereafter
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0043210
- SNOMED CT 2011_0131
- 224526002
- UMLS CUI 2011AA
- C1148523
- UMLS CUI 2011AA
- C0237399
- UMLS CUI 2011AA
- C1518422
- UMLS CUI 2011AA
- C0600109
- SNOMED CT 2011_0131
- 225466006
- UMLS CUI 2011AA
- C0700589
- SNOMED CT 2011_0131
- 146680009
- MedDRA 14.1
- 10010808
- UMLS CUI 2011AA
- C0347984
- SNOMED CT 2011_0131
- 371881003
- UMLS CUI 2011AA
- C0679823
- HL7 V3 2006_05
- PART
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- HL7 V3 2006_05
- MO
- UMLS CUI 2011AA
- C0231290
- SNOMED CT 2011_0131
- 237679004
- UMLS CUI 2011AA
- CL414906
- UMLS CUI 2011AA
- C0086582
- SNOMED CT 2011_0131
- 248153007
- HL7 V3 2006_05
- M
- UMLS CUI 2011AA
- C1518422
- UMLS CUI 2011AA
- C0600109
- SNOMED CT 2011_0131
- 225466006
- UMLS CUI 2011AA
- C0700589
- SNOMED CT 2011_0131
- 146680009
- MedDRA 14.1
- 10010808
- UMLS CUI 2011AA
- C0347984
- SNOMED CT 2011_0131
- 371881003
- UMLS CUI 2011AA
- C0679823
- HL7 V3 2006_05
- PART
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- UMLS CUI 2011AA
- C0231290
- SNOMED CT 2011_0131
- 237679004
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Eligibility
- StudyEvent: Eligibility
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C1705957 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C1291910 (UMLS CUI 2011AA)
115628002 (SNOMED CT 2011_0131)
MTHU003865 (LOINC Version 232)
263654008 (SNOMED CT 2011_0131)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C0151746 (UMLS CUI 2011AA)
39539005 (SNOMED CT 2011_0131)
10013902 (MedDRA 14.1)
C0086565 (UMLS CUI 2011AA)
75183008 (SNOMED CT 2011_0131)
10019670 (MedDRA 14.1)
C0398623 (UMLS CUI 2011AA)
10020608 (MedDRA 14.1)
392521001 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
CL411789 (UMLS CUI 2011AA)
C0023449 (UMLS CUI 2011AA)
91857003, 128822004 (SNOMED CT 2011_0131)
10060390 (MedDRA 14.1)
C91.0 (ICD-10-CM Version 2010)
204.0 (ICD-9-CM Version 2011)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0007117 (UMLS CUI 2011AA)
1338007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0851140 (UMLS CUI 2011AA)
92564006 (SNOMED CT 2011_0131)
10061809 (MedDRA 14.1)
D06.9 (ICD-10-CM Version 2010)
233.1 (ICD-9-CM Version 2011)
55561003 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0205420 (UMLS CUI 2011AA)
68405009 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0750729 (UMLS CUI 2011AA)
288524001 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0019693 (UMLS CUI 2011AA)
86406008 (SNOMED CT 2011_0131)
10020161 (MedDRA 14.1)
MTHU020829 (LOINC Version 232)
B20 (ICD-10-CM Version 2010)
042 (ICD-9-CM Version 2011)
C0151317 (UMLS CUI 2011AA)
177010002 (SNOMED CT 2011_0131)
C0019169 (UMLS CUI 2011AA)
81665004 (SNOMED CT 2011_0131)
C0149709 (UMLS CUI 2011AA)
165806002 (SNOMED CT 2011_0131)
10019742 (MedDRA 14.1)
C0220847 (UMLS CUI 2011AA)
62944002 (SNOMED CT 2011_0131)
10019752 (MedDRA 14.1)
C0281863 (UMLS CUI 2011AA)
10019747 (MedDRA 14.1)
224526002 (SNOMED CT 2011_0131)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
CL414906 (UMLS CUI 2011AA)
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C1518422 (UMLS CUI 2011AA)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)