ID

43472

Description

ODM derived from http://clinicaltrials.gov/show/NCT00822393

Link

http://clinicaltrials.gov/show/NCT00822393

Keywords

Versions (3)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/16/14 4/16/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility DRKS00006115 NCT00822393 Acute Myeloid Leukemia

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 18 Years to 70 Years
Description

age 18 Years to 70 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Patients with acute myeloid leukaemia acc. to WHO, 2001 (AML in complete remission at transplant, i.e. blast counts < 5 % in bone marrow) or myelodysplastic syndrome acc. to WHO, 2001 (MDS with blast counts < 20 % in bone marrow during disease history) indicated for allogeneic haematopoietic progenitor cell transplantation but considered to be at increased risk for standard conditioning therapies according to the following criteria:
Description

Patients with acute myeloid leukaemia acc. to WHO, 2001 (AML in complete remission at transplant, i.e. blast counts < 5 % in bone marrow) or myelodysplastic syndrome acc. to WHO, 2001 (MDS with blast counts < 20 % in bone marrow during disease history) indicated for allogeneic haematopoietic progenitor cell transplantation but considered to be at increased risk for standard conditioning therapies according to the following criteria:

Data type

boolean

Alias
UMLS CUI 2011AA
C0023467
SNOMED CT 2011_0131
91861009
MedDRA 14.1
10000880
ICD-10-CM Version 2010
C92.0
ICD-9-CM Version 2011
205.0
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C0451584
SNOMED CT 2011_0131
273931002
UMLS CUI 2011AA
C0677874
SNOMED CT 2011_0131
103338009
UMLS CUI 2011AA
C0040732
SNOMED CT 2011_0131
77465005
MedDRA 14.1
10057677
UMLS CUI 2011AA
C0523113
SNOMED CT 2011_0131
104102000
MedDRA 14.1
10061700
UMLS CUI 2011AA
C0005953
SNOMED CT 2011_0131
14016003
LOINC Version 232
MTHU016536
UMLS CUI 2011AA
C3463824
SNOMED CT 2011_0131
128623006
MedDRA 14.1
10028533
ICD-10-CM Version 2010
D46
ICD-9-CM Version 2011
238.75
CTCAE 1105E
E12552
UMLS CUI 2011AA
C1444656
SNOMED CT 2011_0131
410535002
UMLS CUI 2011AA
C2242529
MedDRA 14.1
10067862
UMLS CUI 2011AA
C1830377
LOINC Version 232
MTHU021331
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
patients aged >= 50 years at transplant and / or
Description

patients aged >= 50 years at transplant and / or

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C0040732
SNOMED CT 2011_0131
77465005
MedDRA 14.1
10057677
patients with a HCT-CI score > 2 [acc. to Sorror et al., 2005]
Description

patients with a HCT-CI score > 2 [acc. to Sorror et al., 2005]

Data type

boolean

Alias
UMLS CUI 2011AA
C0472699
SNOMED CT 2011_0131
234336002
UMLS CUI 2011AA
C1516737
UMLS CUI 2011AA
C0449820
SNOMED CT 2011_0131
246262008
LOINC Version 232
MTHU024701
Availability of an HLA-identical sibling donor (MRD) or HLA-identical unrelated donor (MUD). Donor selection is based on molecular high resolution typing (4 digits) of class II alleles of the DRB1 and DQB1 gene loci and molecular (at least) low resolution typing (2 digits) of class I alleles (i.e., antigens) of the HLA-A, B, and C gene loci. In case, no class I and class II completely identical donor (10 out of 10 gene loci) can be identified, one antigen disparity (class I) and/or one allele disparity (class II) between patient and donor are acceptable. Conversely, disparity of two antigens (irrespective of the involved gene loci) cannot be accepted. These definitions for the required degree of histocompatibility apply to the selection of related as well as of unrelated donors.
Description

Availability of an HLA-identical sibling donor (MRD) or HLA-identical unrelated donor (MUD). Donor selection is based on molecular high resolution typing (4 digits) of class II alleles of the DRB1 and DQB1 gene loci and molecular (at least) low resolution typing (2 digits) of class I alleles (i.e., antigens) of the HLA-A, B, and C gene loci. In case, no class I and class II completely identical donor (10 out of 10 gene loci) can be identified, one antigen disparity (class I) and/or one allele disparity (class II) between patient and donor are acceptable. Conversely, disparity of two antigens (irrespective of the involved gene loci) cannot be accepted. These definitions for the required degree of histocompatibility apply to the selection of related as well as of unrelated donors.

Data type

boolean

Alias
UMLS CUI 2011AA
C0470187
SNOMED CT 2011_0131
103328004
UMLS CUI 2011AA
C1315037
LOINC Version 232
MTHU000083
UMLS CUI 2011AA
C0205280
SNOMED CT 2011_0131
20323000
UMLS CUI 2011AA
C0037047
SNOMED CT 2011_0131
375005
LOINC Version 232
MTHU016169
HL7 V3 2006_05
SIB
UMLS CUI 2011AA
CL414920
UMLS CUI 2011AA
CL414700
UMLS CUI 2011AA
CL414920
UMLS CUI 2011AA
C1449559
UMLS CUI 2011AA
C0555911
SNOMED CT 2011_0131
260075000
UMLS CUI 2011AA
C0555916
SNOMED CT 2011_0131
260082001
UMLS CUI 2011AA
C0019728
SNOMED CT 2011_0131
49495002
LOINC Version 232
MTHU033943
UMLS CUI 2011AA
C0019737
SNOMED CT 2011_0131
54481006
LOINC Version 232
MTHU027937
UMLS CUI 2011AA
C0019751
SNOMED CT 2011_0131
80188006
LOINC Version 232
MTHU033946
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0449286
SNOMED CT 2011_0131
246173007
UMLS CUI 2011AA
C0019627
Adult patients of both gender, age 18 - 70 years
Description

Adult patients of both gender, age 18 - 70 years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001675
SNOMED CT 2011_0131
133936004
UMLS CUI 2011AA
C1706086
UMLS CUI 2011AA
C0079399
SNOMED CT 2011_0131
263495000
LOINC Version 232
MTHU002975
Karnofsky performance status (assessment scale)
Description

Karnofsky Index >= 60 %

Data type

boolean

Alias
UMLS CUI 2011AA
C0206065
SNOMED CT 2011_0131
273546003
Written informed consent
Description

Written informed consent

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Men capable of reproduction and women of childbearing potential must be willing to consent to using a highly effective method of birth control such as condoms, implants, injectables, combined oral contraceptives, IUDs, sexual abstinence or vasectomised partner while on treatment and for at least 6 months thereafter
Description

Men capable of reproduction and women of childbearing potential must be willing to consent to using a highly effective method of birth control such as condoms, implants, injectables, combined oral contraceptives, IUDs, sexual abstinence or vasectomised partner while on treatment and for at least 6 months thereafter

Data type

boolean

Alias
UMLS CUI 2011AA
C0025266
SNOMED CT 2011_0131
339947000
UMLS CUI 2011AA
C2698977
UMLS CUI 2011AA
C0035150
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0677582
UMLS CUI 2011AA
CL424925
UMLS CUI 2011AA
C1262153
MedDRA 14.1
10062577
UMLS CUI 2011AA
C0457572
SNOMED CT 2011_0131
268458002
UMLS CUI 2011AA
C0021900
SNOMED CT 2011_0131
268460000
MedDRA 14.1
10022745
UMLS CUI 2011AA
C0036899
SNOMED CT 2011_0131
47037006
MedDRA 14.1
10029805
UMLS CUI 2011AA
C0420842
SNOMED CT 2011_0131
268457007
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Patients with acute promyelocytic leukaemia with t(15,17)(q22,q12) and in CR1
Description

Patients with acute promyelocytic leukaemia with t(15,17)(q22,q12) and in CR1

Data type

boolean

Alias
UMLS CUI 2011AA
C0023487
SNOMED CT 2011_0131
110004001
MedDRA 14.1
10001019
ICD-10-CM Version 2010
C92.4
UMLS CUI 2011AA
C1515724
UMLS CUI 2011AA
C0205435
SNOMED CT 2011_0131
255216001
UMLS CUI 2011AA
C0544452
SNOMED CT 2011_0131
277022003
Patients considered contra-indicated for allogeneic HSCT due to severe concomitant illness (within three weeks prior to scheduled day -6):
Description

Patients considered contra-indicated for allogeneic HSCT due to severe concomitant illness (within three weeks prior to scheduled day -6):

Data type

boolean

Alias
UMLS CUI 2011AA
C1444657
SNOMED CT 2011_0131
410536001
UMLS CUI 2011AA
C2242529
MedDRA 14.1
10067862
UMLS CUI 2011AA
CL420107
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0243087
patients with severe renal impairment like patients on dialysis or prior renal transplantation or S-creatinine > 3.0 x ULN or calculated creatinine-clearance < 60 ml/min
Description

patients with severe renal impairment like patients on dialysis or prior renal transplantation or S-creatinine > 3.0 x ULN or calculated creatinine-clearance < 60 ml/min

Data type

boolean

Alias
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C1565489
SNOMED CT 2011_0131
236423003
MedDRA 14.1
10062237
UMLS CUI 2011AA
C0011946
SNOMED CT 2011_0131
108241001
MedDRA 14.1
10061105
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0022671
SNOMED CT 2011_0131
70536003
MedDRA 14.1
10038533
ICD-9-CM Version 2011
55.6
UMLS CUI 2011AA
C0201976
SNOMED CT 2011_0131
113075003
MedDRA 14.1
10040230
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C0444686
SNOMED CT 2011_0131
258090004
UMLS CUI 2011AA
C0373595
SNOMED CT 2011_0131
167181009
MedDRA 14.1
10011371
patients with severe pulmonary impairment, DLCO/or FEV1 < 50 % or severe dyspnoea at rest or requiring oxygen supply
Description

patients with severe pulmonary impairment, DLCO/or FEV1 < 50 % or severe dyspnoea at rest or requiring oxygen supply

Data type

boolean

Alias
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
C1516251
UMLS CUI 2011AA
CL414841
UMLS CUI 2011AA
C0743330
SNOMED CT 2011_0131
161941007
MedDRA 14.1
10013969
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0919655
MedDRA 14.1
10050322
patients with severe cardiac impairment diagnosed by echocardiography and LVEF < 40 %
Description

patients with severe cardiac impairment diagnosed by echocardiography and LVEF < 40 %

Data type

boolean

Alias
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0018799
SNOMED CT 2011_0131
56265001
MedDRA 14.1
10061024
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0013516
SNOMED CT 2011_0131
40701008
MedDRA 14.1
10014116
ICD-9-CM Version 2011
88.72
UMLS CUI 2011AA
C0428772
SNOMED CT 2011_0131
250908004
MedDRA 14.1
10069170
patients with severe hepatic impairment indicated by hyperbilirubinaemia > 3 x ULN or ALT / AST > 5 x ULN
Description

patients with severe hepatic impairment indicated by hyperbilirubinaemia > 3 x ULN or ALT / AST > 5 x ULN

Data type

boolean

Alias
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0948807
MedDRA 14.1
10052254
UMLS CUI 2011AA
C1444656
SNOMED CT 2011_0131
410535002
UMLS CUI 2011AA
C0020433
SNOMED CT 2011_0131
14783006
MedDRA 14.1
10020578
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C0004002
SNOMED CT 2011_0131
26091008
LOINC Version 232
MTHU004883
Active malignant involvement of the CNS
Description

Active malignant involvement of the CNS

Data type

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
CL364385
UMLS CUI 2011AA
C1314939
SNOMED CT 2011_0131
248448006
UMLS CUI 2011AA
C1269563
SNOMED CT 2011_0131
278199004
HIV-positivity, active non-controlled infectious disease under treatment (no decrease of CRP or PCT) including active viral liver infection
Description

HIV-positivity, active non-controlled infectious disease under treatment (no decrease of CRP or PCT) including active viral liver infection

Data type

boolean

Alias
UMLS CUI 2011AA
C0019699
SNOMED CT 2011_0131
165816005
MedDRA 14.1
10020188
ICD-10-CM Version 2010
Z21
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
40733004
MedDRA 14.1
10021881
LOINC Version 232
MTHU034915
ICD-9-CM Version 2011
136.9
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0547047
SNOMED CT 2011_0131
260370003
UMLS CUI 2011AA
C0006560
SNOMED CT 2011_0131
61425002
LOINC Version 232
MTHU002335
UMLS CUI 2011AA
C0072027
SNOMED CT 2011_0131
418752001
LOINC Version 232
MTHU015794
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C0042721
SNOMED CT 2011_0131
3738000
MedDRA 14.1
10019799
LOINC Version 232
MTHU020837
ICD-10-CM Version 2010
B19
ICD-9-CM Version 2011
070
CTCAE 1105E
E11410
Previous allogeneic HSCT
Description

Previous allogeneic HSCT

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C2242529
MedDRA 14.1
10067862
Pleural effusion or ascites > 1.0 L
Description

Pleural effusion or ascites > 1.0 L

Data type

boolean

Alias
UMLS CUI 2011AA
C0032227
SNOMED CT 2011_0131
60046008
MedDRA 14.1
10035598
ICD-10-CM Version 2010
J90
ICD-9-CM Version 2011
511.9
CTCAE 1105E
E13486
UMLS CUI 2011AA
C0003962
SNOMED CT 2011_0131
389026000
MedDRA 14.1
10003445
ICD-10-CM Version 2010
R18
ICD-9-CM Version 2011
789.5
CTCAE 1105E
E10502
Pregnancy or lactation
Description

Pregnancy or lactation

Data type

boolean

Alias
UMLS CUI 2011AA
C0032961
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
Known hypersensitivity to treosulfan, busulfan and/or related ingredients
Description

Known hypersensitivity to treosulfan, busulfan and/or related ingredients

Data type

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0076959
SNOMED CT 2011_0131
395912000
UMLS CUI 2011AA
C0700015
SNOMED CT 2011_0131
387138002
LOINC Version 232
MTHU004760
UMLS CUI 2011AA
C0699792
SNOMED CT 2011_0131
263498003
UMLS CUI 2011AA
CL414967
Participation in another experimental drug trial within 4 weeks prior to day -6 of the protocol
Description

Participation in another experimental drug trial within 4 weeks prior to day -6 of the protocol

Data type

boolean

Alias
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Non-cooperative behaviour or non-compliance
Description

Non-cooperative behaviour or non-compliance

Data type

boolean

Alias
UMLS CUI 2011AA
C0424350
SNOMED CT 2011_0131
248042003
UMLS CUI 2011AA
C0457432
SNOMED CT 2011_0131
258143003
Psychiatric diseases or conditions that might compromise the ability to give informed consent
Description

Psychiatric diseases or conditions that might compromise the ability to give informed consent

Data type

boolean

Alias
UMLS CUI 2011AA
C0004936
SNOMED CT 2011_0131
74732009
MedDRA 14.1
10037174
ICD-10-CM Version 2010
F99
ICD-9-CM Version 2011
290-319.99
UMLS CUI 2011AA
C0809986
UMLS CUI 2011AA
C0221099
SNOMED CT 2011_0131
260379002
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0184704
SNOMED CT 2011_0131
55149002
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age 18 Years to 70 Years
Item
age 18 Years to 70 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Patients with acute myeloid leukaemia acc. to WHO, 2001 (AML in complete remission at transplant, i.e. blast counts < 5 % in bone marrow) or myelodysplastic syndrome acc. to WHO, 2001 (MDS with blast counts < 20 % in bone marrow during disease history) indicated for allogeneic haematopoietic progenitor cell transplantation but considered to be at increased risk for standard conditioning therapies according to the following criteria:
Item
Patients with acute myeloid leukaemia acc. to WHO, 2001 (AML in complete remission at transplant, i.e. blast counts < 5 % in bone marrow) or myelodysplastic syndrome acc. to WHO, 2001 (MDS with blast counts < 20 % in bone marrow during disease history) indicated for allogeneic haematopoietic progenitor cell transplantation but considered to be at increased risk for standard conditioning therapies according to the following criteria:
boolean
C0023467 (UMLS CUI 2011AA)
91861009 (SNOMED CT 2011_0131)
10000880 (MedDRA 14.1)
C92.0 (ICD-10-CM Version 2010)
205.0 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C0451584 (UMLS CUI 2011AA)
273931002 (SNOMED CT 2011_0131)
C0677874 (UMLS CUI 2011AA)
103338009 (SNOMED CT 2011_0131)
C0040732 (UMLS CUI 2011AA)
77465005 (SNOMED CT 2011_0131)
10057677 (MedDRA 14.1)
C0523113 (UMLS CUI 2011AA)
104102000 (SNOMED CT 2011_0131)
10061700 (MedDRA 14.1)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C3463824 (UMLS CUI 2011AA)
128623006 (SNOMED CT 2011_0131)
10028533 (MedDRA 14.1)
D46 (ICD-10-CM Version 2010)
238.75 (ICD-9-CM Version 2011)
E12552 (CTCAE 1105E)
C1444656 (UMLS CUI 2011AA)
410535002 (SNOMED CT 2011_0131)
C2242529 (UMLS CUI 2011AA)
10067862 (MedDRA 14.1)
C1830377 (UMLS CUI 2011AA)
MTHU021331 (LOINC Version 232)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
patients aged >= 50 years at transplant and / or
Item
patients aged >= 50 years at transplant and / or
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0040732 (UMLS CUI 2011AA)
77465005 (SNOMED CT 2011_0131)
10057677 (MedDRA 14.1)
patients with a HCT-CI score > 2 [acc. to Sorror et al., 2005]
Item
patients with a HCT-CI score > 2 [acc. to Sorror et al., 2005]
boolean
C0472699 (UMLS CUI 2011AA)
234336002 (SNOMED CT 2011_0131)
C1516737 (UMLS CUI 2011AA)
C0449820 (UMLS CUI 2011AA)
246262008 (SNOMED CT 2011_0131)
MTHU024701 (LOINC Version 232)
Availability of an HLA-identical sibling donor (MRD) or HLA-identical unrelated donor (MUD). Donor selection is based on molecular high resolution typing (4 digits) of class II alleles of the DRB1 and DQB1 gene loci and molecular (at least) low resolution typing (2 digits) of class I alleles (i.e., antigens) of the HLA-A, B, and C gene loci. In case, no class I and class II completely identical donor (10 out of 10 gene loci) can be identified, one antigen disparity (class I) and/or one allele disparity (class II) between patient and donor are acceptable. Conversely, disparity of two antigens (irrespective of the involved gene loci) cannot be accepted. These definitions for the required degree of histocompatibility apply to the selection of related as well as of unrelated donors.
Item
Availability of an HLA-identical sibling donor (MRD) or HLA-identical unrelated donor (MUD). Donor selection is based on molecular high resolution typing (4 digits) of class II alleles of the DRB1 and DQB1 gene loci and molecular (at least) low resolution typing (2 digits) of class I alleles (i.e., antigens) of the HLA-A, B, and C gene loci. In case, no class I and class II completely identical donor (10 out of 10 gene loci) can be identified, one antigen disparity (class I) and/or one allele disparity (class II) between patient and donor are acceptable. Conversely, disparity of two antigens (irrespective of the involved gene loci) cannot be accepted. These definitions for the required degree of histocompatibility apply to the selection of related as well as of unrelated donors.
boolean
C0470187 (UMLS CUI 2011AA)
103328004 (SNOMED CT 2011_0131)
C1315037 (UMLS CUI 2011AA)
MTHU000083 (LOINC Version 232)
C0205280 (UMLS CUI 2011AA)
20323000 (SNOMED CT 2011_0131)
C0037047 (UMLS CUI 2011AA)
375005 (SNOMED CT 2011_0131)
MTHU016169 (LOINC Version 232)
SIB (HL7 V3 2006_05)
CL414920 (UMLS CUI 2011AA)
CL414700 (UMLS CUI 2011AA)
CL414920 (UMLS CUI 2011AA)
C1449559 (UMLS CUI 2011AA)
C0555911 (UMLS CUI 2011AA)
260075000 (SNOMED CT 2011_0131)
C0555916 (UMLS CUI 2011AA)
260082001 (SNOMED CT 2011_0131)
C0019728 (UMLS CUI 2011AA)
49495002 (SNOMED CT 2011_0131)
MTHU033943 (LOINC Version 232)
C0019737 (UMLS CUI 2011AA)
54481006 (SNOMED CT 2011_0131)
MTHU027937 (LOINC Version 232)
C0019751 (UMLS CUI 2011AA)
80188006 (SNOMED CT 2011_0131)
MTHU033946 (LOINC Version 232)
C1514873 (UMLS CUI 2011AA)
C0449286 (UMLS CUI 2011AA)
246173007 (SNOMED CT 2011_0131)
C0019627 (UMLS CUI 2011AA)
Adult patients of both gender, age 18 - 70 years
Item
Adult patients of both gender, age 18 - 70 years
boolean
C0001675 (UMLS CUI 2011AA)
133936004 (SNOMED CT 2011_0131)
C1706086 (UMLS CUI 2011AA)
C0079399 (UMLS CUI 2011AA)
263495000 (SNOMED CT 2011_0131)
MTHU002975 (LOINC Version 232)
Karnofsky Index >= 60 %
Item
Karnofsky performance status (assessment scale)
boolean
C0206065 (UMLS CUI 2011AA)
273546003 (SNOMED CT 2011_0131)
Written informed consent
Item
Written informed consent
boolean
C0021430 (UMLS CUI 2011AA)
Men capable of reproduction and women of childbearing potential must be willing to consent to using a highly effective method of birth control such as condoms, implants, injectables, combined oral contraceptives, IUDs, sexual abstinence or vasectomised partner while on treatment and for at least 6 months thereafter
Item
Men capable of reproduction and women of childbearing potential must be willing to consent to using a highly effective method of birth control such as condoms, implants, injectables, combined oral contraceptives, IUDs, sexual abstinence or vasectomised partner while on treatment and for at least 6 months thereafter
boolean
C0025266 (UMLS CUI 2011AA)
339947000 (SNOMED CT 2011_0131)
C2698977 (UMLS CUI 2011AA)
C0035150 (UMLS CUI 2011AA)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0680240 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0677582 (UMLS CUI 2011AA)
CL424925 (UMLS CUI 2011AA)
C1262153 (UMLS CUI 2011AA)
10062577 (MedDRA 14.1)
C0457572 (UMLS CUI 2011AA)
268458002 (SNOMED CT 2011_0131)
C0021900 (UMLS CUI 2011AA)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
C0036899 (UMLS CUI 2011AA)
47037006 (SNOMED CT 2011_0131)
10029805 (MedDRA 14.1)
C0420842 (UMLS CUI 2011AA)
268457007 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Patients with acute promyelocytic leukaemia with t(15,17)(q22,q12) and in CR1
Item
Patients with acute promyelocytic leukaemia with t(15,17)(q22,q12) and in CR1
boolean
C0023487 (UMLS CUI 2011AA)
110004001 (SNOMED CT 2011_0131)
10001019 (MedDRA 14.1)
C92.4 (ICD-10-CM Version 2010)
C1515724 (UMLS CUI 2011AA)
C0205435 (UMLS CUI 2011AA)
255216001 (SNOMED CT 2011_0131)
C0544452 (UMLS CUI 2011AA)
277022003 (SNOMED CT 2011_0131)
Patients considered contra-indicated for allogeneic HSCT due to severe concomitant illness (within three weeks prior to scheduled day -6):
Item
Patients considered contra-indicated for allogeneic HSCT due to severe concomitant illness (within three weeks prior to scheduled day -6):
boolean
C1444657 (UMLS CUI 2011AA)
410536001 (SNOMED CT 2011_0131)
C2242529 (UMLS CUI 2011AA)
10067862 (MedDRA 14.1)
CL420107 (UMLS CUI 2011AA)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0243087 (UMLS CUI 2011AA)
patients with severe renal impairment like patients on dialysis or prior renal transplantation or S-creatinine > 3.0 x ULN or calculated creatinine-clearance < 60 ml/min
Item
patients with severe renal impairment like patients on dialysis or prior renal transplantation or S-creatinine > 3.0 x ULN or calculated creatinine-clearance < 60 ml/min
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C1565489 (UMLS CUI 2011AA)
236423003 (SNOMED CT 2011_0131)
10062237 (MedDRA 14.1)
C0011946 (UMLS CUI 2011AA)
108241001 (SNOMED CT 2011_0131)
10061105 (MedDRA 14.1)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0022671 (UMLS CUI 2011AA)
70536003 (SNOMED CT 2011_0131)
10038533 (MedDRA 14.1)
55.6 (ICD-9-CM Version 2011)
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
C0444686 (UMLS CUI 2011AA)
258090004 (SNOMED CT 2011_0131)
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
patients with severe pulmonary impairment, DLCO/or FEV1 < 50 % or severe dyspnoea at rest or requiring oxygen supply
Item
patients with severe pulmonary impairment, DLCO/or FEV1 < 50 % or severe dyspnoea at rest or requiring oxygen supply
boolean
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)
C1516251 (UMLS CUI 2011AA)
CL414841 (UMLS CUI 2011AA)
C0743330 (UMLS CUI 2011AA)
161941007 (SNOMED CT 2011_0131)
10013969 (MedDRA 14.1)
C1514873 (UMLS CUI 2011AA)
C0919655 (UMLS CUI 2011AA)
10050322 (MedDRA 14.1)
patients with severe cardiac impairment diagnosed by echocardiography and LVEF < 40 %
Item
patients with severe cardiac impairment diagnosed by echocardiography and LVEF < 40 %
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0013516 (UMLS CUI 2011AA)
40701008 (SNOMED CT 2011_0131)
10014116 (MedDRA 14.1)
88.72 (ICD-9-CM Version 2011)
C0428772 (UMLS CUI 2011AA)
250908004 (SNOMED CT 2011_0131)
10069170 (MedDRA 14.1)
patients with severe hepatic impairment indicated by hyperbilirubinaemia > 3 x ULN or ALT / AST > 5 x ULN
Item
patients with severe hepatic impairment indicated by hyperbilirubinaemia > 3 x ULN or ALT / AST > 5 x ULN
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0948807 (UMLS CUI 2011AA)
10052254 (MedDRA 14.1)
C1444656 (UMLS CUI 2011AA)
410535002 (SNOMED CT 2011_0131)
C0020433 (UMLS CUI 2011AA)
14783006 (SNOMED CT 2011_0131)
10020578 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
Active malignant involvement of the CNS
Item
Active malignant involvement of the CNS
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
CL364385 (UMLS CUI 2011AA)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C1269563 (UMLS CUI 2011AA)
278199004 (SNOMED CT 2011_0131)
HIV-positivity, active non-controlled infectious disease under treatment (no decrease of CRP or PCT) including active viral liver infection
Item
HIV-positivity, active non-controlled infectious disease under treatment (no decrease of CRP or PCT) including active viral liver infection
boolean
C0019699 (UMLS CUI 2011AA)
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
40733004 (SNOMED CT 2011_0131)
10021881 (MedDRA 14.1)
MTHU034915 (LOINC Version 232)
136.9 (ICD-9-CM Version 2011)
C0039798 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0547047 (UMLS CUI 2011AA)
260370003 (SNOMED CT 2011_0131)
C0006560 (UMLS CUI 2011AA)
61425002 (SNOMED CT 2011_0131)
MTHU002335 (LOINC Version 232)
C0072027 (UMLS CUI 2011AA)
418752001 (SNOMED CT 2011_0131)
MTHU015794 (LOINC Version 232)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0042721 (UMLS CUI 2011AA)
3738000 (SNOMED CT 2011_0131)
10019799 (MedDRA 14.1)
MTHU020837 (LOINC Version 232)
B19 (ICD-10-CM Version 2010)
070 (ICD-9-CM Version 2011)
E11410 (CTCAE 1105E)
Previous allogeneic HSCT
Item
Previous allogeneic HSCT
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C2242529 (UMLS CUI 2011AA)
10067862 (MedDRA 14.1)
Pleural effusion or ascites > 1.0 L
Item
Pleural effusion or ascites > 1.0 L
boolean
C0032227 (UMLS CUI 2011AA)
60046008 (SNOMED CT 2011_0131)
10035598 (MedDRA 14.1)
J90 (ICD-10-CM Version 2010)
511.9 (ICD-9-CM Version 2011)
E13486 (CTCAE 1105E)
C0003962 (UMLS CUI 2011AA)
389026000 (SNOMED CT 2011_0131)
10003445 (MedDRA 14.1)
R18 (ICD-10-CM Version 2010)
789.5 (ICD-9-CM Version 2011)
E10502 (CTCAE 1105E)
Pregnancy or lactation
Item
Pregnancy or lactation
boolean
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Known hypersensitivity to treosulfan, busulfan and/or related ingredients
Item
Known hypersensitivity to treosulfan, busulfan and/or related ingredients
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0076959 (UMLS CUI 2011AA)
395912000 (SNOMED CT 2011_0131)
C0700015 (UMLS CUI 2011AA)
387138002 (SNOMED CT 2011_0131)
MTHU004760 (LOINC Version 232)
C0699792 (UMLS CUI 2011AA)
263498003 (SNOMED CT 2011_0131)
CL414967 (UMLS CUI 2011AA)
Participation in another experimental drug trial within 4 weeks prior to day -6 of the protocol
Item
Participation in another experimental drug trial within 4 weeks prior to day -6 of the protocol
boolean
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Non-cooperative behaviour or non-compliance
Item
Non-cooperative behaviour or non-compliance
boolean
C0424350 (UMLS CUI 2011AA)
248042003 (SNOMED CT 2011_0131)
C0457432 (UMLS CUI 2011AA)
258143003 (SNOMED CT 2011_0131)
Psychiatric diseases or conditions that might compromise the ability to give informed consent
Item
Psychiatric diseases or conditions that might compromise the ability to give informed consent
boolean
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
C0809986 (UMLS CUI 2011AA)
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0184704 (UMLS CUI 2011AA)
55149002 (SNOMED CT 2011_0131)
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