age up to 18 Years
Item
age up to 18 Years
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)
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)