ID

5122

Descrição

ODM derived from http://clinicaltrials.gov/show/NCT01195480

Link

http://clinicaltrials.gov/show/NCT01195480

Palavras-chave

Versões (3)
  1. 19/03/2013 19/03/2013 - Martin Dugas
  2. 19/04/2014 19/04/2014 - Julian Varghese
  3. 20/09/2021 20/09/2021 -
Transferido a

19 de abril de 2014

DOI

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Licença

Creative Commons BY 4.0
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Eligibility NCT01195480 Acute Lymphoblastic Leukemia

Alemão Inglês

Eligibility

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Descrição

Einschlusskriterien

Alter bis 18 Jahre
Descrição

age up to 18 Years

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Pre-emptive arm
Descrição

Pre-emptive arm

Tipo de dados

boolean

Children (18 years or younger) with CD19+ precursor B cell ALL fulfilling one of the following criteria who are undergoing an allogeneic stem cell transplant from an EBV-seropositive donor:
Descrição

Children (18 years or younger) with CD19+ precursor B cell ALL fulfilling one of the following criteria who are undergoing an allogeneic stem cell transplant from an EBV-seropositive donor:

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0279584
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C2242529
MedDRA 14.1
10067862
UMLS CUI 2011AA
C0014644
SNOMED CT 2011_0131
40168006
UMLS CUI 2011AA
C0521143
SNOMED CT 2011_0131
4879001
UMLS CUI 2011AA
CL414920
In first remission, if at least one of the following criteria are met:
Descrição

In first remission, if at least one of the following criteria are met:

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0205435
SNOMED CT 2011_0131
255216001
UMLS CUI 2011AA
C0544452
SNOMED CT 2011_0131
277022003
UMLS CUI 2011AA
C1550543
HL7 V3 2006_05
FLFS
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
CL414621
t(9;22) and prednisone poor response or not in molecular remission (BCR-ABL/ABL ratio > 0.02%) pre-HSCT or
Descrição

t(9;22) and prednisone poor response or not in molecular remission (BCR-ABL/ABL ratio > 0.02%) pre-HSCT or

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C1515809
UMLS CUI 2011AA
C0032952
SNOMED CT 2011_0131
116602009
LOINC Version 232
MTHU003245
UMLS CUI 2011AA
C1320680
SNOMED CT 2011_0131
405786003
UMLS CUI 2011AA
C0004891
SNOMED CT 2011_0131
56564003
LOINC Version 232
MTHU021298
UMLS CUI 2011AA
C1412097
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2242529
MedDRA 14.1
10067862
Infant ALL age < 6 months at diagnosis with MLL gene rearrangement and either presenting wcc >300 x 109/L or poor steroid early response (i.e circulating blast count >1x109/L following 7 day steroid pre-phase of Interfant 06) or
Descrição

Infant ALL age < 6 months at diagnosis with MLL gene rearrangement and either presenting wcc >300 x 109/L or poor steroid early response (i.e circulating blast count >1x109/L following 7 day steroid pre-phase of Interfant 06) or

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0021270
SNOMED CT 2011_0131
133931009
MedDRA 14.1
10021731
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
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1506987
LOINC Version 232
MTHU016470
UMLS CUI 2011AA
C0023508
SNOMED CT 2011_0131
767002
MedDRA 14.1
10047939
UMLS CUI 2011AA
C0523113
SNOMED CT 2011_0131
104102000
MedDRA 14.1
10061700
Resistant disease (> 30% blasts at end of induction treatment day 28-33) in subsequent morphological CR or
Descrição

Resistant disease (> 30% blasts at end of induction treatment day 28-33) in subsequent morphological CR or

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0332325
SNOMED CT 2011_0131
30714006
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0600558
UMLS CUI 2011AA
C0332437
SNOMED CT 2011_0131
116676008
LOINC Version 232
MTHU008051
UMLS CUI 2011AA
C0677874
SNOMED CT 2011_0131
103338009
High level bone marrow MRD (> 1 in 1000) at week 12 ALL-BFM 2000/AIEOP BFM ALL 2009/EORTC 58951 protocols, week 12-15 of FRALLE A or at week 14 of UKALL2010
Descrição

High level bone marrow MRD (> 1 in 1000) at week 12 ALL-BFM 2000/AIEOP BFM ALL 2009/EORTC 58951 protocols, week 12-15 of FRALLE A or at week 14 of UKALL2010

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0205250
SNOMED CT 2011_0131
75540009
UMLS CUI 2011AA
C0456079
SNOMED CT 2011_0131
276625007
UMLS CUI 2011AA
C0005953
SNOMED CT 2011_0131
14016003
LOINC Version 232
MTHU016536
UMLS CUI 2011AA
C0242596
Relapsed patients if at least one of the following criteria are met:
Descrição

Relapsed patients if at least one of the following criteria are met:

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0277556
SNOMED CT 2011_0131
58184002
UMLS CUI 2011AA
C1550543
HL7 V3 2006_05
FLFS
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
CL414621
Very early (< 18 months from diagnosis) bone marrow or extramedullary relapse in second CR or
Descrição

Very early (< 18 months from diagnosis) bone marrow or extramedullary relapse in second CR or

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0442824
SNOMED CT 2011_0131
260358002
UMLS CUI 2011AA
C1279919
SNOMED CT 2011_0131
264499004
UMLS CUI 2011AA
C0005953
SNOMED CT 2011_0131
14016003
LOINC Version 232
MTHU016536
UMLS CUI 2011AA
C1517060
UMLS CUI 2011AA
C0277556
SNOMED CT 2011_0131
58184002
UMLS CUI 2011AA
C0205436
SNOMED CT 2011_0131
81170007
UMLS CUI 2011AA
C0677874
SNOMED CT 2011_0131
103338009
Early (within 6 months of finishing therapy) isolated bone marrow relapse with bone marrow MRD > 1 in 100 at day 35 of reinduction in second CR or
Descrição

Early (within 6 months of finishing therapy) isolated bone marrow relapse with bone marrow MRD > 1 in 100 at day 35 of reinduction in second CR or

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C1279919
SNOMED CT 2011_0131
264499004
UMLS CUI 2011AA
C0205409
SNOMED CT 2011_0131
46651001
UMLS CUI 2011AA
C0005953
SNOMED CT 2011_0131
14016003
LOINC Version 232
MTHU016536
UMLS CUI 2011AA
C0277556
SNOMED CT 2011_0131
58184002
UMLS CUI 2011AA
C0242596
UMLS CUI 2011AA
C0205341
SNOMED CT 2011_0131
27582007
UMLS CUI 2011AA
C0600558
UMLS CUI 2011AA
C0205436
SNOMED CT 2011_0131
81170007
UMLS CUI 2011AA
C0677874
SNOMED CT 2011_0131
103338009
Early (within 6 months of finishing therapy) bone marrow or combined relapse with high level bone marrow MRD (> 1 in 1000) at the end of consolidation therapy (week 12-13 UKALL R3/INTREALL and COOPRALL protocols, prior to protocol M in BFM relapse protocol (ALL-REZ BFM 2002) and after Protocol II-IDA in AIEOP LLA Rec 2003) These patients have a high (> 50%) risk of relapse and will be monitored for evidence of MRD in bone marrow aspirates (monthly for months 1-6, 6 weekly months 7.5-12 post HSCT) for the first year post-transplant. Patients who become MRD +ve in the marrow at a level minimum 5 x 10-4 but are in morphological remission (<5% blasts in BM) will be eligible to be treated pre-emptively with CD19zeta transduced CTL
Descrição

Early (within 6 months of finishing therapy) bone marrow or combined relapse with high level bone marrow MRD (> 1 in 1000) at the end of consolidation therapy (week 12-13 UKALL R3/INTREALL and COOPRALL protocols, prior to protocol M in BFM relapse protocol (ALL-REZ BFM 2002) and after Protocol II-IDA in AIEOP LLA Rec 2003) These patients have a high (> 50%) risk of relapse and will be monitored for evidence of MRD in bone marrow aspirates (monthly for months 1-6, 6 weekly months 7.5-12 post HSCT) for the first year post-transplant. Patients who become MRD +ve in the marrow at a level minimum 5 x 10-4 but are in morphological remission (<5% blasts in BM) will be eligible to be treated pre-emptively with CD19zeta transduced CTL

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C1279919
SNOMED CT 2011_0131
264499004
UMLS CUI 2011AA
C0005953
SNOMED CT 2011_0131
14016003
LOINC Version 232
MTHU016536
UMLS CUI 2011AA
C0205195
SNOMED CT 2011_0131
89780004
UMLS CUI 2011AA
C0277556
SNOMED CT 2011_0131
58184002
UMLS CUI 2011AA
C0205250
SNOMED CT 2011_0131
75540009
UMLS CUI 2011AA
C0456079
SNOMED CT 2011_0131
276625007
UMLS CUI 2011AA
C0005953
SNOMED CT 2011_0131
14016003
LOINC Version 232
MTHU016536
UMLS CUI 2011AA
C0242596
UMLS CUI 2011AA
C1511484
UMLS CUI 2011AA
C0332167
SNOMED CT 2011_0131
15508007
UMLS CUI 2011AA
C0277556
SNOMED CT 2011_0131
58184002
UMLS CUI 2011AA
CL415337
Prophylaxis arm
Descrição

Prophylaxis arm

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0199176
SNOMED CT 2011_0131
360271000
MedDRA 14.1
10036898
UMLS CUI 2011AA
C1522541
Additionally, any patient (≤ 18 years) with ALL relapsing in the bone marrow (isolated or combined) after myeloablative allogeneic HSCT who achieves morphological remission after re-induction and who is a candidate for second HSCT at one of the participating centres is eligible to receive CD19zeta transduced CTL prophylactically
Descrição

Additionally, any patient (≤ 18 years) with ALL relapsing in the bone marrow (isolated or combined) after myeloablative allogeneic HSCT who achieves morphological remission after re-induction and who is a candidate for second HSCT at one of the participating centres is eligible to receive CD19zeta transduced CTL prophylactically

Tipo de dados

boolean

Alias
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
C0277556
SNOMED CT 2011_0131
58184002
UMLS CUI 2011AA
C0005953
SNOMED CT 2011_0131
14016003
LOINC Version 232
MTHU016536
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
C0085079
SNOMED CT 2011_0131
118490006
UMLS CUI 2011AA
C2242529
MedDRA 14.1
10067862
UMLS CUI 2011AA
C0332437
SNOMED CT 2011_0131
116676008
LOINC Version 232
MTHU008051
UMLS CUI 2011AA
C0544452
SNOMED CT 2011_0131
277022003
UMLS CUI 2011AA
C0205341
SNOMED CT 2011_0131
27582007
UMLS CUI 2011AA
C0600558
Stem cell donors must be EBV sero-positive and HLA-matched (10/10) or a single antigenic/allelic (9/10) mismatch with the recipient
Descrição

Stem cell donors must be EBV sero-positive and HLA-matched (10/10) or a single antigenic/allelic (9/10) mismatch with the recipient

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0375877
SNOMED CT 2011_0131
430792005
MedDRA 14.1
10072068
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C0014644
SNOMED CT 2011_0131
40168006
UMLS CUI 2011AA
C0521143
SNOMED CT 2011_0131
4879001
UMLS CUI 2011AA
C1315037
LOINC Version 232
MTHU000083
UMLS CUI 2011AA
C1708943
UMLS CUI 2011AA
C0205171
SNOMED CT 2011_0131
50607009
UMLS CUI 2011AA
C0003320
SNOMED CT 2011_0131
7120007
LOINC Version 232
MTHU007668
UMLS CUI 2011AA
C0002085
SNOMED CT 2011_0131
9109004
UMLS CUI 2011AA
C1881865
UMLS CUI 2011AA
C1709854
A life expectancy of at least 8 weeks
Descrição

A life expectancy of at least 8 weeks

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0023671
Karnofsky score of >60% if >10 years old or Lansky performance score of > 60 if <= 10 years old
Descrição

Karnofsky score of >60% if >10 years old or Lansky performance score of > 60 if <= 10 years old

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0206065
SNOMED CT 2011_0131
273546003
UMLS CUI 2011AA
C1522275
Patients must have transduced donor-derived EBV-specific CTLs with 15% or higher expression of CD19zeta determined by flow-cytometry which meet the specified release criteria
Descrição

Patients must have transduced donor-derived EBV-specific CTLs with 15% or higher expression of CD19zeta determined by flow-cytometry which meet the specified release criteria

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C0040667
SNOMED CT 2011_0131
2351004
UMLS CUI 2011AA
CL414920
UMLS CUI 2011AA
C1441547
UMLS CUI 2011AA
C0014644
SNOMED CT 2011_0131
40168006
UMLS CUI 2011AA
C1552740
HL7 V3 2006_05
INSTANCE
UMLS CUI 2011AA
C0039195
SNOMED CT 2011_0131
420638008
UMLS CUI 2011AA
C1413206
LOINC Version 232
MTHU018355
UMLS CUI 2011AA
C1719914
SNOMED CT 2011_0131
420605004
UMLS CUI 2011AA
C0017262
SNOMED CT 2011_0131
89551006
UMLS CUI 2011AA
C0016263
SNOMED CT 2011_0131
64444005
MedDRA 14.1
10065440
HL7 V3 2006_05
0251
Informed written consent indicating that patients are aware this is a research study and have been told of its possible benefits and toxic side effects
Descrição

Informed written consent indicating that patients are aware this is a research study and have been told of its possible benefits and toxic side effects

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C1576874
HL7 V3 2006_05
WRITTEN
UMLS CUI 2011AA
C0021430
UMLS CUI 2011AA
C0332149
SNOMED CT 2011_0131
371930009
UMLS CUI 2011AA
C0814225
UMLS CUI 2011AA
CL034921
UMLS CUI 2011AA
CL330043
Ausschlusskriterien
Descrição

Ausschlusskriterien

EBV seronegative or > single antigenic/allelic HLA-mismatched donor
Descrição

EBV seronegative or > single antigenic/allelic HLA-mismatched donor

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0014644
SNOMED CT 2011_0131
40168006
UMLS CUI 2011AA
C0521144
SNOMED CT 2011_0131
81321002
UMLS CUI 2011AA
C0439093
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
UMLS CUI 2011AA
C0205171
SNOMED CT 2011_0131
50607009
UMLS CUI 2011AA
C0003320
SNOMED CT 2011_0131
7120007
LOINC Version 232
MTHU007668
UMLS CUI 2011AA
C0002085
SNOMED CT 2011_0131
9109004
UMLS CUI 2011AA
C0019721
SNOMED CT 2011_0131
47038001
LOINC Version 232
MTHU018438
UMLS CUI 2011AA
C1881865
UMLS CUI 2011AA
CL414920
Active acute GVHD overall Grade 2 or higher or significant chronic GVHD requiring systemic steroids at the time of scheduled infusion of transduced CTL will be excluded until the patient is GVHD-free and off steroids
Descrição

Active acute GVHD overall Grade 2 or higher or significant chronic GVHD requiring systemic steroids at the time of scheduled infusion of transduced CTL will be excluded until the patient is GVHD-free and off steroids

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0205178
SNOMED CT 2011_0131
272118002
UMLS CUI 2011AA
C0018133
SNOMED CT 2011_0131
234646005
MedDRA 14.1
10018651
ICD-10-CM Version 2010
D89.813
ICD-9-CM Version 2011
279.50
UMLS CUI 2011AA
C0441800
SNOMED CT 2011_0131
258349007
LOINC Version 232
MTHU003112
UMLS CUI 2011AA
C0867389
SNOMED CT 2011_0131
402356004
MedDRA 14.1
10066261
ICD-10-CM Version 2010
D89.811
ICD-9-CM Version 2011
279.52
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C2911187
ICD-10-CM Version 2010
Z79.52
Pre-existing severe lung disease (FEV1 or FVC < 50% predicted) pre-HSCT or an oxygen requirement of >28% O2 supplementation or active pulmonary infiltrates on chest X-ray at the time scheduled for transduced CTL infusion
Descrição

Pre-existing severe lung disease (FEV1 or FVC < 50% predicted) pre-HSCT or an oxygen requirement of >28% O2 supplementation or active pulmonary infiltrates on chest X-ray at the time scheduled for transduced CTL infusion

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C2347662
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0024115
SNOMED CT 2011_0131
19829001
MedDRA 14.1
10025082
ICD-10-CM Version 2010
J98.4
UMLS CUI 2011AA
CL414841
UMLS CUI 2011AA
C0802685
LOINC Version 232
19870-5
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0919655
MedDRA 14.1
10050322
UMLS CUI 2011AA
C0235896
MedDRA 14.1
10025102
UMLS CUI 2011AA
C0039985
SNOMED CT 2011_0131
399208008
MedDRA 14.1
10008498
Serum bilirubin >3 times the upper limit of normal or an AST or ALT > 5 times the upper limit of normal
Descrição

Serum bilirubin >3 times the upper limit of normal or an AST or ALT > 5 times the upper limit of normal

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0428441
SNOMED CT 2011_0131
166610007
MedDRA 14.1
10040157
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
Serum creatinine >3 times upper limit of normal
Descrição

Serum creatinine >3 times upper limit of normal

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0201976
Active severe intercurrent infection at the time of transduced CTL infusion (if present consult with Chief investigator).
Descrição

Active severe intercurrent infection at the time of transduced CTL infusion (if present consult with Chief investigator).

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0240021
Patients in whom transduced donor-derived EBV-specific CTLs don't meet release criteria
Descrição

Patients in whom transduced donor-derived EBV-specific CTLs don't meet release criteria

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0040667
SNOMED CT 2011_0131
2351004
UMLS CUI 2011AA
CL414920
UMLS CUI 2011AA
C1441547
UMLS CUI 2011AA
C0014644
SNOMED CT 2011_0131
40168006
UMLS CUI 2011AA
C1552740
HL7 V3 2006_05
INSTANCE
UMLS CUI 2011AA
C0039195
SNOMED CT 2011_0131
420638008
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1550543
HL7 V3 2006_05
FLFS
UMLS CUI 2011AA
C1283071
SNOMED CT 2011_0131
129299003
UMLS CUI 2011AA
CL414621
Serologically positive for Hepatitis B, C or HIV pre-HSCT
Descrição

Serologically positive for Hepatitis B, C or HIV pre-HSCT

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0856706
MedDRA 14.1
10019738
UMLS CUI 2011AA
C1112419
MedDRA 14.1
10057394
UMLS CUI 2011AA
C0019699
SNOMED CT 2011_0131
165816005
MedDRA 14.1
10020188
ICD-10-CM Version 2010
Z21
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2242529
MedDRA 14.1
10067862
Females of childbearing age with a positive pregnancy test
Descrição

Females of childbearing age with a positive pregnancy test

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C0240802
SNOMED CT 2011_0131
250423000
MedDRA 14.1
10036575
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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
Einschlusskriterien
age up to 18 Years
Item
Alter bis 18 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Pre-emptive arm
Item
Pre-emptive arm
boolean
Children (18 years or younger) with CD19+ precursor B cell ALL fulfilling one of the following criteria who are undergoing an allogeneic stem cell transplant from an EBV-seropositive donor:
Item
Children (18 years or younger) with CD19+ precursor B cell ALL fulfilling one of the following criteria who are undergoing an allogeneic stem cell transplant from an EBV-seropositive donor:
boolean
C0279584 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1514756 (UMLS CUI 2011AA)
C2242529 (UMLS CUI 2011AA)
10067862 (MedDRA 14.1)
C0014644 (UMLS CUI 2011AA)
40168006 (SNOMED CT 2011_0131)
C0521143 (UMLS CUI 2011AA)
4879001 (SNOMED CT 2011_0131)
CL414920 (UMLS CUI 2011AA)
In first remission, if at least one of the following criteria are met:
Item
In first remission, if at least one of the following criteria are met:
boolean
C0205435 (UMLS CUI 2011AA)
255216001 (SNOMED CT 2011_0131)
C0544452 (UMLS CUI 2011AA)
277022003 (SNOMED CT 2011_0131)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
t(9;22) and prednisone poor response or not in molecular remission (BCR-ABL/ABL ratio > 0.02%) pre-HSCT or
Item
t(9;22) and prednisone poor response or not in molecular remission (BCR-ABL/ABL ratio > 0.02%) pre-HSCT or
boolean
C1515809 (UMLS CUI 2011AA)
C0032952 (UMLS CUI 2011AA)
116602009 (SNOMED CT 2011_0131)
MTHU003245 (LOINC Version 232)
C1320680 (UMLS CUI 2011AA)
405786003 (SNOMED CT 2011_0131)
C0004891 (UMLS CUI 2011AA)
56564003 (SNOMED CT 2011_0131)
MTHU021298 (LOINC Version 232)
C1412097 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2242529 (UMLS CUI 2011AA)
10067862 (MedDRA 14.1)
Infant ALL age < 6 months at diagnosis with MLL gene rearrangement and either presenting wcc >300 x 109/L or poor steroid early response (i.e circulating blast count >1x109/L following 7 day steroid pre-phase of Interfant 06) or
Item
Infant ALL age < 6 months at diagnosis with MLL gene rearrangement and either presenting wcc >300 x 109/L or poor steroid early response (i.e circulating blast count >1x109/L following 7 day steroid pre-phase of Interfant 06) or
boolean
C0021270 (UMLS CUI 2011AA)
133931009 (SNOMED CT 2011_0131)
10021731 (MedDRA 14.1)
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)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1506987 (UMLS CUI 2011AA)
MTHU016470 (LOINC Version 232)
C0023508 (UMLS CUI 2011AA)
767002 (SNOMED CT 2011_0131)
10047939 (MedDRA 14.1)
C0523113 (UMLS CUI 2011AA)
104102000 (SNOMED CT 2011_0131)
10061700 (MedDRA 14.1)
Resistant disease (> 30% blasts at end of induction treatment day 28-33) in subsequent morphological CR or
Item
Resistant disease (> 30% blasts at end of induction treatment day 28-33) in subsequent morphological CR or
boolean
C0332325 (UMLS CUI 2011AA)
30714006 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0600558 (UMLS CUI 2011AA)
C0332437 (UMLS CUI 2011AA)
116676008 (SNOMED CT 2011_0131)
MTHU008051 (LOINC Version 232)
C0677874 (UMLS CUI 2011AA)
103338009 (SNOMED CT 2011_0131)
High level bone marrow MRD (> 1 in 1000) at week 12 ALL-BFM 2000/AIEOP BFM ALL 2009/EORTC 58951 protocols, week 12-15 of FRALLE A or at week 14 of UKALL2010
Item
High level bone marrow MRD (> 1 in 1000) at week 12 ALL-BFM 2000/AIEOP BFM ALL 2009/EORTC 58951 protocols, week 12-15 of FRALLE A or at week 14 of UKALL2010
boolean
C0205250 (UMLS CUI 2011AA)
75540009 (SNOMED CT 2011_0131)
C0456079 (UMLS CUI 2011AA)
276625007 (SNOMED CT 2011_0131)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C0242596 (UMLS CUI 2011AA)
Relapsed patients if at least one of the following criteria are met:
Item
Relapsed patients if at least one of the following criteria are met:
boolean
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
Very early (< 18 months from diagnosis) bone marrow or extramedullary relapse in second CR or
Item
Very early (< 18 months from diagnosis) bone marrow or extramedullary relapse in second CR or
boolean
C0442824 (UMLS CUI 2011AA)
260358002 (SNOMED CT 2011_0131)
C1279919 (UMLS CUI 2011AA)
264499004 (SNOMED CT 2011_0131)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C1517060 (UMLS CUI 2011AA)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C0205436 (UMLS CUI 2011AA)
81170007 (SNOMED CT 2011_0131)
C0677874 (UMLS CUI 2011AA)
103338009 (SNOMED CT 2011_0131)
Early (within 6 months of finishing therapy) isolated bone marrow relapse with bone marrow MRD > 1 in 100 at day 35 of reinduction in second CR or
Item
Early (within 6 months of finishing therapy) isolated bone marrow relapse with bone marrow MRD > 1 in 100 at day 35 of reinduction in second CR or
boolean
C1279919 (UMLS CUI 2011AA)
264499004 (SNOMED CT 2011_0131)
C0205409 (UMLS CUI 2011AA)
46651001 (SNOMED CT 2011_0131)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C0242596 (UMLS CUI 2011AA)
C0205341 (UMLS CUI 2011AA)
27582007 (SNOMED CT 2011_0131)
C0600558 (UMLS CUI 2011AA)
C0205436 (UMLS CUI 2011AA)
81170007 (SNOMED CT 2011_0131)
C0677874 (UMLS CUI 2011AA)
103338009 (SNOMED CT 2011_0131)
Early (within 6 months of finishing therapy) bone marrow or combined relapse with high level bone marrow MRD (> 1 in 1000) at the end of consolidation therapy (week 12-13 UKALL R3/INTREALL and COOPRALL protocols, prior to protocol M in BFM relapse protocol (ALL-REZ BFM 2002) and after Protocol II-IDA in AIEOP LLA Rec 2003) These patients have a high (> 50%) risk of relapse and will be monitored for evidence of MRD in bone marrow aspirates (monthly for months 1-6, 6 weekly months 7.5-12 post HSCT) for the first year post-transplant. Patients who become MRD +ve in the marrow at a level minimum 5 x 10-4 but are in morphological remission (<5% blasts in BM) will be eligible to be treated pre-emptively with CD19zeta transduced CTL
Item
Early (within 6 months of finishing therapy) bone marrow or combined relapse with high level bone marrow MRD (> 1 in 1000) at the end of consolidation therapy (week 12-13 UKALL R3/INTREALL and COOPRALL protocols, prior to protocol M in BFM relapse protocol (ALL-REZ BFM 2002) and after Protocol II-IDA in AIEOP LLA Rec 2003) These patients have a high (> 50%) risk of relapse and will be monitored for evidence of MRD in bone marrow aspirates (monthly for months 1-6, 6 weekly months 7.5-12 post HSCT) for the first year post-transplant. Patients who become MRD +ve in the marrow at a level minimum 5 x 10-4 but are in morphological remission (<5% blasts in BM) will be eligible to be treated pre-emptively with CD19zeta transduced CTL
boolean
C1279919 (UMLS CUI 2011AA)
264499004 (SNOMED CT 2011_0131)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C0205195 (UMLS CUI 2011AA)
89780004 (SNOMED CT 2011_0131)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C0205250 (UMLS CUI 2011AA)
75540009 (SNOMED CT 2011_0131)
C0456079 (UMLS CUI 2011AA)
276625007 (SNOMED CT 2011_0131)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C0242596 (UMLS CUI 2011AA)
C1511484 (UMLS CUI 2011AA)
C0332167 (UMLS CUI 2011AA)
15508007 (SNOMED CT 2011_0131)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
CL415337 (UMLS CUI 2011AA)
Prophylaxis arm
Item
Prophylaxis arm
boolean
C0199176 (UMLS CUI 2011AA)
360271000 (SNOMED CT 2011_0131)
10036898 (MedDRA 14.1)
C1522541 (UMLS CUI 2011AA)
Additionally, any patient (≤ 18 years) with ALL relapsing in the bone marrow (isolated or combined) after myeloablative allogeneic HSCT who achieves morphological remission after re-induction and who is a candidate for second HSCT at one of the participating centres is eligible to receive CD19zeta transduced CTL prophylactically
Item
Additionally, any patient (≤ 18 years) with ALL relapsing in the bone marrow (isolated or combined) after myeloablative allogeneic HSCT who achieves morphological remission after re-induction and who is a candidate for second HSCT at one of the participating centres is eligible to receive CD19zeta transduced CTL prophylactically
boolean
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)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C0085079 (UMLS CUI 2011AA)
118490006 (SNOMED CT 2011_0131)
C2242529 (UMLS CUI 2011AA)
10067862 (MedDRA 14.1)
C0332437 (UMLS CUI 2011AA)
116676008 (SNOMED CT 2011_0131)
MTHU008051 (LOINC Version 232)
C0544452 (UMLS CUI 2011AA)
277022003 (SNOMED CT 2011_0131)
C0205341 (UMLS CUI 2011AA)
27582007 (SNOMED CT 2011_0131)
C0600558 (UMLS CUI 2011AA)
Stem cell donors must be EBV sero-positive and HLA-matched (10/10) or a single antigenic/allelic (9/10) mismatch with the recipient
Item
Stem cell donors must be EBV sero-positive and HLA-matched (10/10) or a single antigenic/allelic (9/10) mismatch with the recipient
boolean
C0375877 (UMLS CUI 2011AA)
430792005 (SNOMED CT 2011_0131)
10072068 (MedDRA 14.1)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0014644 (UMLS CUI 2011AA)
40168006 (SNOMED CT 2011_0131)
C0521143 (UMLS CUI 2011AA)
4879001 (SNOMED CT 2011_0131)
C1315037 (UMLS CUI 2011AA)
MTHU000083 (LOINC Version 232)
C1708943 (UMLS CUI 2011AA)
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C0003320 (UMLS CUI 2011AA)
7120007 (SNOMED CT 2011_0131)
MTHU007668 (LOINC Version 232)
C0002085 (UMLS CUI 2011AA)
9109004 (SNOMED CT 2011_0131)
C1881865 (UMLS CUI 2011AA)
C1709854 (UMLS CUI 2011AA)
A life expectancy of at least 8 weeks
Item
A life expectancy of at least 8 weeks
boolean
C0023671 (UMLS CUI 2011AA)
Karnofsky score of >60% if >10 years old or Lansky performance score of > 60 if <= 10 years old
Item
Karnofsky score of >60% if >10 years old or Lansky performance score of > 60 if <= 10 years old
boolean
C0206065 (UMLS CUI 2011AA)
273546003 (SNOMED CT 2011_0131)
C1522275 (UMLS CUI 2011AA)
Patients must have transduced donor-derived EBV-specific CTLs with 15% or higher expression of CD19zeta determined by flow-cytometry which meet the specified release criteria
Item
Patients must have transduced donor-derived EBV-specific CTLs with 15% or higher expression of CD19zeta determined by flow-cytometry which meet the specified release criteria
boolean
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0040667 (UMLS CUI 2011AA)
2351004 (SNOMED CT 2011_0131)
CL414920 (UMLS CUI 2011AA)
C1441547 (UMLS CUI 2011AA)
C0014644 (UMLS CUI 2011AA)
40168006 (SNOMED CT 2011_0131)
C1552740 (UMLS CUI 2011AA)
INSTANCE (HL7 V3 2006_05)
C0039195 (UMLS CUI 2011AA)
420638008 (SNOMED CT 2011_0131)
C1413206 (UMLS CUI 2011AA)
MTHU018355 (LOINC Version 232)
C1719914 (UMLS CUI 2011AA)
420605004 (SNOMED CT 2011_0131)
C0017262 (UMLS CUI 2011AA)
89551006 (SNOMED CT 2011_0131)
C0016263 (UMLS CUI 2011AA)
64444005 (SNOMED CT 2011_0131)
10065440 (MedDRA 14.1)
0251 (HL7 V3 2006_05)
Informed written consent indicating that patients are aware this is a research study and have been told of its possible benefits and toxic side effects
Item
Informed written consent indicating that patients are aware this is a research study and have been told of its possible benefits and toxic side effects
boolean
C1576874 (UMLS CUI 2011AA)
WRITTEN (HL7 V3 2006_05)
C0021430 (UMLS CUI 2011AA)
C0332149 (UMLS CUI 2011AA)
371930009 (SNOMED CT 2011_0131)
C0814225 (UMLS CUI 2011AA)
CL034921 (UMLS CUI 2011AA)
CL330043 (UMLS CUI 2011AA)
Item Group
Ausschlusskriterien
EBV seronegative or > single antigenic/allelic HLA-mismatched donor
Item
EBV seronegative or > single antigenic/allelic HLA-mismatched donor
boolean
C0014644 (UMLS CUI 2011AA)
40168006 (SNOMED CT 2011_0131)
C0521144 (UMLS CUI 2011AA)
81321002 (SNOMED CT 2011_0131)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C0003320 (UMLS CUI 2011AA)
7120007 (SNOMED CT 2011_0131)
MTHU007668 (LOINC Version 232)
C0002085 (UMLS CUI 2011AA)
9109004 (SNOMED CT 2011_0131)
C0019721 (UMLS CUI 2011AA)
47038001 (SNOMED CT 2011_0131)
MTHU018438 (LOINC Version 232)
C1881865 (UMLS CUI 2011AA)
CL414920 (UMLS CUI 2011AA)
Active acute GVHD overall Grade 2 or higher or significant chronic GVHD requiring systemic steroids at the time of scheduled infusion of transduced CTL will be excluded until the patient is GVHD-free and off steroids
Item
Active acute GVHD overall Grade 2 or higher or significant chronic GVHD requiring systemic steroids at the time of scheduled infusion of transduced CTL will be excluded until the patient is GVHD-free and off steroids
boolean
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C0018133 (UMLS CUI 2011AA)
234646005 (SNOMED CT 2011_0131)
10018651 (MedDRA 14.1)
D89.813 (ICD-10-CM Version 2010)
279.50 (ICD-9-CM Version 2011)
C0441800 (UMLS CUI 2011AA)
258349007 (SNOMED CT 2011_0131)
MTHU003112 (LOINC Version 232)
C0867389 (UMLS CUI 2011AA)
402356004 (SNOMED CT 2011_0131)
10066261 (MedDRA 14.1)
D89.811 (ICD-10-CM Version 2010)
279.52 (ICD-9-CM Version 2011)
C1514873 (UMLS CUI 2011AA)
C2911187 (UMLS CUI 2011AA)
Z79.52 (ICD-10-CM Version 2010)
Pre-existing severe lung disease (FEV1 or FVC < 50% predicted) pre-HSCT or an oxygen requirement of >28% O2 supplementation or active pulmonary infiltrates on chest X-ray at the time scheduled for transduced CTL infusion
Item
Pre-existing severe lung disease (FEV1 or FVC < 50% predicted) pre-HSCT or an oxygen requirement of >28% O2 supplementation or active pulmonary infiltrates on chest X-ray at the time scheduled for transduced CTL infusion
boolean
C2347662 (UMLS CUI 2011AA)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0024115 (UMLS CUI 2011AA)
19829001 (SNOMED CT 2011_0131)
10025082 (MedDRA 14.1)
J98.4 (ICD-10-CM Version 2010)
CL414841 (UMLS CUI 2011AA)
C0802685 (UMLS CUI 2011AA)
19870-5 (LOINC Version 232)
C1514873 (UMLS CUI 2011AA)
C0919655 (UMLS CUI 2011AA)
10050322 (MedDRA 14.1)
C0235896 (UMLS CUI 2011AA)
10025102 (MedDRA 14.1)
C0039985 (UMLS CUI 2011AA)
399208008 (SNOMED CT 2011_0131)
10008498 (MedDRA 14.1)
Serum bilirubin >3 times the upper limit of normal or an AST or ALT > 5 times the upper limit of normal
Item
Serum bilirubin >3 times the upper limit of normal or an AST or ALT > 5 times the upper limit of normal
boolean
C0428441 (UMLS CUI 2011AA)
166610007 (SNOMED CT 2011_0131)
10040157 (MedDRA 14.1)
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)
Serum creatinine >3 times upper limit of normal
Item
Serum creatinine >3 times upper limit of normal
boolean
C0201976 (UMLS CUI 2011AA)
Active severe intercurrent infection at the time of transduced CTL infusion (if present consult with Chief investigator).
Item
Active severe intercurrent infection at the time of transduced CTL infusion (if present consult with Chief investigator).
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0240021 (UMLS CUI 2011AA)
Patients in whom transduced donor-derived EBV-specific CTLs don't meet release criteria
Item
Patients in whom transduced donor-derived EBV-specific CTLs don't meet release criteria
boolean
C0040667 (UMLS CUI 2011AA)
2351004 (SNOMED CT 2011_0131)
CL414920 (UMLS CUI 2011AA)
C1441547 (UMLS CUI 2011AA)
C0014644 (UMLS CUI 2011AA)
40168006 (SNOMED CT 2011_0131)
C1552740 (UMLS CUI 2011AA)
INSTANCE (HL7 V3 2006_05)
C0039195 (UMLS CUI 2011AA)
420638008 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C1283071 (UMLS CUI 2011AA)
129299003 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
Serologically positive for Hepatitis B, C or HIV pre-HSCT
Item
Serologically positive for Hepatitis B, C or HIV pre-HSCT
boolean
C0856706 (UMLS CUI 2011AA)
10019738 (MedDRA 14.1)
C1112419 (UMLS CUI 2011AA)
10057394 (MedDRA 14.1)
C0019699 (UMLS CUI 2011AA)
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2242529 (UMLS CUI 2011AA)
10067862 (MedDRA 14.1)
Females of childbearing age with a positive pregnancy test
Item
Females of childbearing age with a positive pregnancy test
boolean
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0240802 (UMLS CUI 2011AA)
250423000 (SNOMED CT 2011_0131)
10036575 (MedDRA 14.1)
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