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)
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)