ID

4303

Descrição

ODM derived from http://clinicaltrials.gov/show/NCT01207388

Link

http://clinicaltrials.gov/show/NCT01207388

Palavras-chave

Versões (3)
  1. 06/12/2013 06/12/2013 - Martin Dugas
  2. 19/04/2014 19/04/2014 - Julian Varghese
  3. 27/09/2021 27/09/2021 -
Transferido a

6 de dezembro de 2013

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT01207388 B-ALL

Alemão Inglês

Eligibility

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Descrição

Inclusion Criteria

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

age at least 18 Years

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Patients with B-precursor ALL in complete hematological remission after at least 3 intense chemotherapy blocks
Descrição

Patients with B-precursor ALL in complete hematological remission after at least 3 intense chemotherapy blocks

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C1292769
SNOMED CT 2011_0131
128823009
MedDRA 14.1
10003890
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0205488
SNOMED CT 2011_0131
57407000
UMLS CUI 2011AA
C0677874
SNOMED CT 2011_0131
103338009
UMLS CUI 2011AA
C0522510
SNOMED CT 2011_0131
103370009
UMLS CUI 2011AA
C1302181
SNOMED CT 2011_0131
399042005
Presence of minimal residual disease at a level of >=10-3
Descrição

Presence of minimal residual disease at a level of >=10-3

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0242596
UMLS CUI 2011AA
C0456079
SNOMED CT 2011_0131
276625007
Availability of bone marrow specimen from primary diagnosis for clone-specific MRD assessment
Descrição

Availability of bone marrow specimen from primary diagnosis for clone-specific MRD assessment

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0470187
SNOMED CT 2011_0131
103328004
UMLS CUI 2011AA
C0438737
SNOMED CT 2011_0131
119359002
UMLS CUI 2011AA
C0801658
LOINC Version 232
18630-4
UMLS CUI 2011AA
C1522642
UMLS CUI 2011AA
C1552740
HL7 V3 2006_05
INSTANCE
UMLS CUI 2011AA
C0242596
UMLS CUI 2011AA
C1516048
Negative HIV test, negative hepatitis B (HbsAg) test and hepatitis C virus (anti-HCV) test
Descrição

Negative HIV test, negative hepatitis B (HbsAg) test and hepatitis C virus (anti-HCV) test

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0481430
SNOMED CT 2011_0131
143223008
MedDRA 14.1
10020179
UMLS CUI 2011AA
C1611173
MedDRA 14.1
10065002
UMLS CUI 2011AA
C0919711
SNOMED CT 2011_0131
406010001
MedDRA 14.1
10050542
UMLS CUI 2011AA
C1619717
MedDRA 14.1
10065001
UMLS CUI 2011AA
C0166049
SNOMED CT 2011_0131
72165005
LOINC Version 232
MTHU004551
UMLS CUI 2011AA
C0392366
SNOMED CT 2011_0131
272393004
Negative pregnancy test in women of childbearing potential
Descrição

Negative pregnancy test in women of childbearing potential

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0427780
SNOMED CT 2011_0131
250425007
MedDRA 14.1
10036574
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
ECOG performance status 0 or 1
Descrição

ECOG performance status 0 or 1

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C1828078
SNOMED CT 2011_0131
425389002
UMLS CUI 2011AA
C1827388
SNOMED CT 2011_0131
422512005
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Presence of circulating blasts or current extra-medullary involvement by ALL
Descrição

Presence of circulating blasts or current extra-medullary involvement by ALL

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
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
C1517060
UMLS CUI 2011AA
C1314939
SNOMED CT 2011_0131
248448006
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
History of relevant CNS pathology or current CNS pathology
Descrição

History of relevant CNS pathology or current CNS pathology

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C2347946
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C1269563
SNOMED CT 2011_0131
278199004
UMLS CUI 2011AA
C0677042
Prior allogeneic HSCT
Descrição

Prior allogeneic HSCT

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2242529
MedDRA 14.1
10067862
Eligibility for treatment with TKIs
Descrição

Eligibility for treatment with TKIs

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0013893
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1268567
SNOMED CT 2011_0131
372917005
Systemic cancer chemotherapy within 2 weeks prior to study treatment
Descrição

Systemic cancer chemotherapy within 2 weeks prior to study treatment

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C1883256
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
C0205448
SNOMED CT 2011_0131
19338005
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
Therapy with monoclonal antibodies (rituximab, alemtuzumab) within 4 weeks prior to study treatment
Descrição

Therapy with monoclonal antibodies (rituximab, alemtuzumab) within 4 weeks prior to study treatment

Tipo de dados

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
Previous treatment with blinatumomab
Descrição

Previous treatment with blinatumomab

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C1722284
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Similar models

Eligibility

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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 B-precursor ALL in complete hematological remission after at least 3 intense chemotherapy blocks
Item
Patients with B-precursor ALL in complete hematological remission after at least 3 intense chemotherapy blocks
boolean
C1292769 (UMLS CUI 2011AA)
128823009 (SNOMED CT 2011_0131)
10003890 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0205488 (UMLS CUI 2011AA)
57407000 (SNOMED CT 2011_0131)
C0677874 (UMLS CUI 2011AA)
103338009 (SNOMED CT 2011_0131)
C0522510 (UMLS CUI 2011AA)
103370009 (SNOMED CT 2011_0131)
C1302181 (UMLS CUI 2011AA)
399042005 (SNOMED CT 2011_0131)
Presence of minimal residual disease at a level of >=10-3
Item
Presence of minimal residual disease at a level of >=10-3
boolean
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0242596 (UMLS CUI 2011AA)
C0456079 (UMLS CUI 2011AA)
276625007 (SNOMED CT 2011_0131)
Availability of bone marrow specimen from primary diagnosis for clone-specific MRD assessment
Item
Availability of bone marrow specimen from primary diagnosis for clone-specific MRD assessment
boolean
C0470187 (UMLS CUI 2011AA)
103328004 (SNOMED CT 2011_0131)
C0438737 (UMLS CUI 2011AA)
119359002 (SNOMED CT 2011_0131)
C0801658 (UMLS CUI 2011AA)
18630-4 (LOINC Version 232)
C1522642 (UMLS CUI 2011AA)
C1552740 (UMLS CUI 2011AA)
INSTANCE (HL7 V3 2006_05)
C0242596 (UMLS CUI 2011AA)
C1516048 (UMLS CUI 2011AA)
Negative HIV test, negative hepatitis B (HbsAg) test and hepatitis C virus (anti-HCV) test
Item
Negative HIV test, negative hepatitis B (HbsAg) test and hepatitis C virus (anti-HCV) test
boolean
C0481430 (UMLS CUI 2011AA)
143223008 (SNOMED CT 2011_0131)
10020179 (MedDRA 14.1)
C1611173 (UMLS CUI 2011AA)
10065002 (MedDRA 14.1)
C0919711 (UMLS CUI 2011AA)
406010001 (SNOMED CT 2011_0131)
10050542 (MedDRA 14.1)
C1619717 (UMLS CUI 2011AA)
10065001 (MedDRA 14.1)
C0166049 (UMLS CUI 2011AA)
72165005 (SNOMED CT 2011_0131)
MTHU004551 (LOINC Version 232)
C0392366 (UMLS CUI 2011AA)
272393004 (SNOMED CT 2011_0131)
Negative pregnancy test in women of childbearing potential
Item
Negative pregnancy test in women of childbearing potential
boolean
C0427780 (UMLS CUI 2011AA)
250425007 (SNOMED CT 2011_0131)
10036574 (MedDRA 14.1)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
ECOG performance status 0 or 1
Item
ECOG performance status 0 or 1
boolean
C1828078 (UMLS CUI 2011AA)
425389002 (SNOMED CT 2011_0131)
C1827388 (UMLS CUI 2011AA)
422512005 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Presence of circulating blasts or current extra-medullary involvement by ALL
Item
Presence of circulating blasts or current extra-medullary involvement by ALL
boolean
C0150312 (UMLS CUI 2011AA)
52101004 (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)
C1517060 (UMLS CUI 2011AA)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
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)
History of relevant CNS pathology or current CNS pathology
Item
History of relevant CNS pathology or current CNS pathology
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C2347946 (UMLS CUI 2011AA)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C1269563 (UMLS CUI 2011AA)
278199004 (SNOMED CT 2011_0131)
C0677042 (UMLS CUI 2011AA)
Prior allogeneic HSCT
Item
Prior allogeneic HSCT
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2242529 (UMLS CUI 2011AA)
10067862 (MedDRA 14.1)
Eligibility for treatment with TKIs
Item
Eligibility for treatment with TKIs
boolean
C0013893 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C1268567 (UMLS CUI 2011AA)
372917005 (SNOMED CT 2011_0131)
Systemic cancer chemotherapy within 2 weeks prior to study treatment
Item
Systemic cancer chemotherapy within 2 weeks prior to study treatment
boolean
C1883256 (UMLS CUI 2011AA)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
Therapy with monoclonal antibodies (rituximab, alemtuzumab) within 4 weeks prior to study treatment
Item
Therapy with monoclonal antibodies (rituximab, alemtuzumab) within 4 weeks prior to study treatment
boolean
C0039798 (UMLS CUI 2011AA)
C0003250 (UMLS CUI 2011AA)
49616005 (SNOMED CT 2011_0131)
C0732355 (UMLS CUI 2011AA)
386919002 (SNOMED CT 2011_0131)
C0383429 (UMLS CUI 2011AA)
391864003 (SNOMED CT 2011_0131)
Previous treatment with blinatumomab
Item
Previous treatment with blinatumomab
boolean
C1514463 (UMLS CUI 2011AA)
C1722284 (UMLS CUI 2011AA)
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