ID
4533
Description
ODM derived from http://clinicaltrials.gov/show/NCT00560794
Link
http://clinicaltrials.gov/show/NCT00560794
Keywords
Versions (3)
- 12/10/13 12/10/13 - Martin Dugas
- 4/14/14 4/14/14 - Julian Varghese
- 9/20/21 9/20/21 -
Uploaded on
December 10, 2013
DOI
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License
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00560794 Acute Lymphoblastic Leukemia
Eligibility
- StudyEvent: Eligibility
Description
Exclusion Criteria
Alias
- UMLS CUI 2011AA
- CL425201
Description
Current extra medullar involvement
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0521116
- SNOMED CT 2011_0131
- 15240007
- UMLS CUI 2011AA
- C1517060
- UMLS CUI 2011AA
- C1314939
- SNOMED CT 2011_0131
- 248448006
Description
History of or current relevant CNS pathology (except migraine/headache and/or previous infiltration of cerebrospinal fluid (CSF) by ALL)
Data type
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
Description
Current infiltration of cerebrospinal fluid by ALL
Data type
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
Description
History of or current autoimmune disease
Data type
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
Description
Autologous stem cell transplantation within 6 weeks prior to study entry
Data type
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
Description
Any prior allogeneic stem cell transplantation
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C2242529
- MedDRA 14.1
- 10067862
Description
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)
Data type
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
Description
Radiotherapy within 4 weeks prior to study treatment
Data type
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
Description
Therapy with monoclonal antibodies (Rituximab, MabCampath) within 6 weeks prior to study treatment
Data type
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
Description
Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation
Data type
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
Description
Presence of human anti-murine antibodies (HAMA)
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0150312
- SNOMED CT 2011_0131
- 52101004
- UMLS CUI 2011AA
- C1291910
- SNOMED CT 2011_0131
- 115628002
- LOINC Version 232
- MTHU003865
Description
Abnormal bone marrow, renal or hepatic function
Data type
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
Description
Indication for a hypercoagulative state
Data type
boolean
Alias
- UMLS CUI 2011AA
- CL335836
- UMLS CUI 2011AA
- C0542027
- MedDRA 14.1
- 10020608
Description
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
Data type
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
Description
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
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0205082
- SNOMED CT 2011_0131
- 24484000
- UMLS CUI 2011AA
- C0021311
- 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
Description
Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti-HCV positive
Data type
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
Description
Pregnant or nursing women
Data type
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
Description
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
Data type
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
- C0024554
- 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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418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0021027 (UMLS CUI 2011AA)
399771004 (SNOMED CT 2011_0131)
14 (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C1705248 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
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)
C0542027 (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)
C0021311 (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)
C0024554 (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)