age at least 40 Years
Item
age at least 40 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Diagnosis of AML according to WHO criteria.
Item
Diagnosis of AML according to WHO criteria.
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
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)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C0451584 (UMLS CUI 2011AA)
273931002 (SNOMED CT 2011_0131)
Untreated relapse or refractory disease after a minimum of one standard induction therapy. Treatment of relapse with leukocyte-apheresis or up to 5 days with low dose cytarabine or hydroxyurea is allowed.
Item
Untreated relapse or refractory disease after a minimum of one standard induction therapy. Treatment of relapse with leukocyte-apheresis or up to 5 days with low dose cytarabine or hydroxyurea is allowed.
boolean
C1518422 (UMLS CUI 2011AA)
CL415147 (UMLS CUI 2011AA)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C1514815 (UMLS CUI 2011AA)
C1524031 (UMLS CUI 2011AA)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0600558 (UMLS CUI 2011AA)
C1524004 (UMLS CUI 2011AA)
C0023416 (UMLS CUI 2011AA)
77257005 (SNOMED CT 2011_0131)
10051524 (MedDRA 14.1)
99.72 (ICD-9-CM Version 2011)
C0445550 (UMLS CUI 2011AA)
262459003 (SNOMED CT 2011_0131)
C0010711 (UMLS CUI 2011AA)
89265009 (SNOMED CT 2011_0131)
C0020402 (UMLS CUI 2011AA)
56602009 (SNOMED CT 2011_0131)
Refractory disease is defined as >=5% blasts after the second cycle of induction therapy or no reduction in marrow blasts at early treatment assessment (day +15) after the first cycle of induction therapy.
Item
Refractory disease is defined as >=5% blasts after the second cycle of induction therapy or no reduction in marrow blasts at early treatment assessment (day +15) after the first cycle of induction therapy.
boolean
C1514815 (UMLS CUI 2011AA)
C1704788 (UMLS CUI 2011AA)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205451 (UMLS CUI 2011AA)
34001005 (SNOMED CT 2011_0131)
C0439165 (UMLS CUI 2011AA)
118582008 (SNOMED CT 2011_0131)
C0368761 (UMLS CUI 2011AA)
312256009 (SNOMED CT 2011_0131)
MTHU005201 (LOINC Version 232)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0392756 (UMLS CUI 2011AA)
260400001 (SNOMED CT 2011_0131)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C0368761 (UMLS CUI 2011AA)
312256009 (SNOMED CT 2011_0131)
MTHU005201 (LOINC Version 232)
Relapse is defined as an increase in bone marrow blast count >=5%, re-appearance of blasts in the peripheral blood or extramedullary disease.
Item
Relapse is defined as an increase in bone marrow blast count >=5%, re-appearance of blasts in the peripheral blood or extramedullary disease.
boolean
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C1704788 (UMLS CUI 2011AA)
C0442805 (UMLS CUI 2011AA)
260366006 (SNOMED CT 2011_0131)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C0523113 (UMLS CUI 2011AA)
104102000 (SNOMED CT 2011_0131)
10061700 (MedDRA 14.1)
C0205341 (UMLS CUI 2011AA)
27582007 (SNOMED CT 2011_0131)
C0243132 (UMLS CUI 2011AA)
C0368761 (UMLS CUI 2011AA)
312256009 (SNOMED CT 2011_0131)
MTHU005201 (LOINC Version 232)
C0229664 (UMLS CUI 2011AA)
119273009 (SNOMED CT 2011_0131)
MTHU003709 (LOINC Version 232)
C1517060 (UMLS CUI 2011AA)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
Have adequate renal and hepatic functions as indicated by the following laboratory values:
Item
Have adequate renal and hepatic functions as indicated by the following laboratory values:
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
C0232741 (UMLS CUI 2011AA)
79036002 (SNOMED CT 2011_0131)
Serum creatinine <=1.0 mg/dL. If serum creatinine >1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be >60 mL/min/1.73 m2 (see reference below*)
Item
Serum creatinine <=1.0 mg/dL. If serum creatinine >1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be >60 mL/min/1.73 m2 (see reference below*)
boolean
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C0750572 (UMLS CUI 2011AA)
414135002 (SNOMED CT 2011_0131)
C0017654 (UMLS CUI 2011AA)
80274001 (SNOMED CT 2011_0131)
10018355 (MedDRA 14.1)
Serum bilirubin <=1.5 x upper limit of normal (ULN)
Item
Serum bilirubin <=1.5 x upper limit of normal (ULN)
boolean
C1278039 (UMLS CUI 2011AA)
166610007 (SNOMED CT 2011_0131)
10040157 (MedDRA 14.1)
Aspartate transaminase (AST)/alanine transaminase (ALT) <=2.5 x ULN
Item
Aspartate transaminase (AST)/alanine transaminase (ALT) <=2.5 x ULN
boolean
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)
Alkaline phosphatase <=2.5 x ULN
Item
Alkaline phosphatase <=2.5 x ULN
boolean
C0002059 (UMLS CUI 2011AA)
57056007 (SNOMED CT 2011_0131)
MTHU005195 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
Eligibility for intensive chemotherapy
Item
Eligibility for intensive chemotherapy
boolean
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
C0522510 (UMLS CUI 2011AA)
103370009 (SNOMED CT 2011_0131)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
Patient needs to be capable to understand the clinical trial as an investigational approach to bridge the time to potential allogeneic HCT, potential risks and benefits of the study.
Item
Patient needs to be capable to understand the clinical trial as an investigational approach to bridge the time to potential allogeneic HCT, potential risks and benefits of the study.
boolean
C1273101 (UMLS CUI 2011AA)
395659009 (SNOMED CT 2011_0131)
C0681832 (UMLS CUI 2011AA)
C0332149 (UMLS CUI 2011AA)
371930009 (SNOMED CT 2011_0131)
C2242529 (UMLS CUI 2011AA)
10067862 (MedDRA 14.1)
C0524785 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Signed written informed consent.
Item
Signed written informed consent.
boolean
C0021430 (UMLS CUI 2011AA)
Female patients of childbearing potential must have a negative serum
Item
Female patients of childbearing potential must have a negative serum
boolean
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
CL415098 (UMLS CUI 2011AA)
C0229671 (UMLS CUI 2011AA)
67922002 (SNOMED CT 2011_0131)
MTHU001009 (LOINC Version 232)
Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
Item
Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
boolean
C0024554 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
For refractory disease, more than two prior induction chemotherapies or more than one prior salvage chemotherapy containing high-dose cytarabine (cumulative dose of cytarabine >= 5 g/m2).
Item
For refractory disease, more than two prior induction chemotherapies or more than one prior salvage chemotherapy containing high-dose cytarabine (cumulative dose of cytarabine >= 5 g/m2).
boolean
C1514815 (UMLS CUI 2011AA)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C3179010 (UMLS CUI 2011AA)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0085405 (UMLS CUI 2011AA)
10068833 (MedDRA 14.1)
C0444956 (UMLS CUI 2011AA)
261829003 (SNOMED CT 2011_0131)
C0010711 (UMLS CUI 2011AA)
89265009 (SNOMED CT 2011_0131)
Second or higher relapse. Patients who received hypomethylating agents like azacytidine or decitabine as a treatment of first relapse, respond and relapse later on may be included.
Item
Second or higher relapse. Patients who received hypomethylating agents like azacytidine or decitabine as a treatment of first relapse, respond and relapse later on may be included.
boolean
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C1254351 (UMLS CUI 2011AA)
CL414898 (UMLS CUI 2011AA)
C2613367 (UMLS CUI 2011AA)
C0004475 (UMLS CUI 2011AA)
412329008 (SNOMED CT 2011_0131)
C0049065 (UMLS CUI 2011AA)
420517007 (SNOMED CT 2011_0131)
C0332149 (UMLS CUI 2011AA)
371930009 (SNOMED CT 2011_0131)
C1302261 (UMLS CUI 2011AA)
399223003 (SNOMED CT 2011_0131)
Acute promyelocytic leukemia with t(15;17)(q22;q12) molecular detection or (PML/RARalpha).
Item
Acute promyelocytic leukemia with t(15;17)(q22;q12) molecular detection or (PML/RARalpha).
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)
CL414625 (UMLS CUI 2011AA)
C1511790 (UMLS CUI 2011AA)
C0279625 (UMLS CUI 2011AA)
Central nervous system involvement (i.e. WBC >= 5/microL in cerebrospinal fluid with blasts present on cytospin).
Item
Central nervous system involvement (i.e. WBC >= 5/microL in cerebrospinal fluid with blasts present on cytospin).
boolean
C0449389 (UMLS CUI 2011AA)
260766009 (SNOMED CT 2011_0131)
C0023508 (UMLS CUI 2011AA)
767002 (SNOMED CT 2011_0131)
10047939 (MedDRA 14.1)
C1271796 (UMLS CUI 2011AA)
391308009 (SNOMED CT 2011_0131)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0368761 (UMLS CUI 2011AA)
312256009 (SNOMED CT 2011_0131)
MTHU005201 (LOINC Version 232)
Prior allogeneic HCT
Item
Prior allogeneic HCT
boolean
C2242529 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
10067862 (MedDRA 14.1)
Autologous transplantation within 100 days prior to start of study treatment
Item
Autologous transplantation within 100 days prior to start of study treatment
boolean
C0040736 (UMLS CUI 2011AA)
53088000 (SNOMED CT 2011_0131)
10064285 (MedDRA 14.1)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C1704407 (UMLS CUI 2011AA)
420528006 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
Use of investigational agents or anticancer therapy within 10 days before study entry with the exception of hydroxyurea or low-dose cytarabine.
Item
Use of investigational agents or anticancer therapy within 10 days before study entry with the exception of hydroxyurea or low-dose cytarabine.
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C0920425 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0020402 (UMLS CUI 2011AA)
56602009 (SNOMED CT 2011_0131)
C0445550 (UMLS CUI 2011AA)
262459003 (SNOMED CT 2011_0131)
C0010711 (UMLS CUI 2011AA)
89265009 (SNOMED CT 2011_0131)
Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo transplantation.
Item
Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo transplantation.
boolean
C0205420 (UMLS CUI 2011AA)
68405009 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0349410 (UMLS CUI 2011AA)
251526004 (SNOMED CT 2011_0131)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
C0022658 (UMLS CUI 2011AA)
90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0460002 (UMLS CUI 2011AA)
91689009 (SNOMED CT 2011_0131)
Patients with known refractoriness to platelet support.
Item
Patients with known refractoriness to platelet support.
boolean
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C0205269 (UMLS CUI 2011AA)
20646008 (SNOMED CT 2011_0131)
C0005821 (UMLS CUI 2011AA)
16378004 (SNOMED CT 2011_0131)
MTHU002432 (LOINC Version 232)
C1521721 (UMLS CUI 2011AA)
Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
Item
Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
boolean
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0026946 (UMLS CUI 2011AA)
3218000 (SNOMED CT 2011_0131)
10017533 (MedDRA 14.1)
B35-B49 (ICD-10-CM Version 2010)
110-118.99 (ICD-9-CM Version 2011)
C0004623 (UMLS CUI 2011AA)
87628006 (SNOMED CT 2011_0131)
10060945 (MedDRA 14.1)
A49.9 (ICD-10-CM Version 2010)
C0042769 (UMLS CUI 2011AA)
34014006 (SNOMED CT 2011_0131)
10047461 (MedDRA 14.1)
B34.9 (ICD-10-CM Version 2010)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
Pregnant or lactating patients.
Item
Pregnant or lactating patients.
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C2828358 (UMLS CUI 2011AA)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
Item
Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
boolean
C0205420 (UMLS CUI 2011AA)
68405009 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
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)
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C1113679 (UMLS CUI 2011AA)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0525058 (UMLS CUI 2011AA)
C0459471 (UMLS CUI 2011AA)
280452008 (SNOMED CT 2011_0131)
MTHU003869 (LOINC Version 232)
C0683954 (UMLS CUI 2011AA)