age 18 Years to 85 Years
Item
Alter 18 bis 85 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Males and females age ≥18 years in second relapse or refractory.
Item
Males and females age ≥18 years in second relapse or refractory.
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)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0205436 (UMLS CUI 2011AA)
81170007 (SNOMED CT 2011_0131)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C0205269 (UMLS CUI 2011AA)
20646008 (SNOMED CT 2011_0131)
Males and females age ≥60 years in first relapse or refractory.
Item
Males and females age ≥60 years in first relapse or refractory.
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)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0205435 (UMLS CUI 2011AA)
255216001 (SNOMED CT 2011_0131)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C0205269 (UMLS CUI 2011AA)
20646008 (SNOMED CT 2011_0131)
Must have baseline bone marrow sample taken.
Item
Must have baseline bone marrow sample taken.
boolean
C1442488 (UMLS CUI 2011AA)
C0438737 (UMLS CUI 2011AA)
119359002 (SNOMED CT 2011_0131)
Morphologically documented primary AML or AML secondary to myelodysplastic syndrome (MDS with ≥20% bone marrow or peripheral blasts), as defined by the World Health Organization (WHO) criteria, confirmed by pathology review at treating institution.
Item
Morphologically documented primary AML or AML secondary to myelodysplastic syndrome (MDS with ≥20% bone marrow or peripheral blasts), as defined by the World Health Organization (WHO) criteria, confirmed by pathology review at treating institution.
boolean
C0332437 (UMLS CUI 2011AA)
116676008 (SNOMED CT 2011_0131)
MTHU008051 (LOINC Version 232)
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
CL414904 (UMLS CUI 2011AA)
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)
C0280449 (UMLS CUI 2011AA)
C0026986 (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)
C1704788 (UMLS CUI 2011AA)
C0451584 (UMLS CUI 2011AA)
273931002 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
C1521733 (UMLS CUI 2011AA)
29458008 (SNOMED CT 2011_0131)
C1552617 (UMLS CUI 2011AA)
REV (HL7 V3 2006_05)
Able to swallow the liquid study drug.
Item
Able to swallow the liquid study drug.
boolean
C0566356 (UMLS CUI 2011AA)
288936000 (SNOMED CT 2011_0131)
C0302908 (UMLS CUI 2011AA)
33463005 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
ECOG performance status of 0 to 2
Item
ECOG performance status of 0 to 2
boolean
C1828078 (UMLS CUI 2011AA)
425389002 (SNOMED CT 2011_0131)
C1827388 (UMLS CUI 2011AA)
422512005 (SNOMED CT 2011_0131)
C1828242 (UMLS CUI 2011AA)
422894000 (SNOMED CT 2011_0131)
In the absence of rapidly progressing disease, the interval from prior treatment to time of AC220 administration will be at least 2 weeks for cytotoxic agents or at least 5 half-lives for noncytotoxic agents. The use of chemotherapeutic or antileukemic agents other than hydroxyurea is not permitted during the study with the possible exception of intrathecal (IT) therapy at the discretion of the Investigator and with the agreement of the Sponsor.
Item
In the absence of rapidly progressing disease, the interval from prior treatment to time of AC220 administration will be at least 2 weeks for cytotoxic agents or at least 5 half-lives for noncytotoxic agents. The use of chemotherapeutic or antileukemic agents other than hydroxyurea is not permitted during the study with the possible exception of intrathecal (IT) therapy at the discretion of the Investigator and with the agreement of the Sponsor.
boolean
C1272706 (UMLS CUI 2011AA)
385673002 (SNOMED CT 2011_0131)
C1514463 (UMLS CUI 2011AA)
C1533734 (UMLS CUI 2011AA)
416118004 (SNOMED CT 2011_0131)
CL374311 (UMLS CUI 2011AA)
C0304497 (UMLS CUI 2011AA)
373526007 (SNOMED CT 2011_0131)
C2827065 (UMLS CUI 2011AA)
C1554075 (UMLS CUI 2011AA)
NP (HL7 V3 2006_05)
C0729502 (UMLS CUI 2011AA)
312059006 (SNOMED CT 2011_0131)
C0596112 (UMLS CUI 2011AA)
CL411789 (UMLS CUI 2011AA)
C0020402 (UMLS CUI 2011AA)
56602009 (SNOMED CT 2011_0131)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0205527 (UMLS CUI 2011AA)
72607000 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
Persistent chronic clinically significant non-hematological toxicities from prior treatment must be ≤ Grade 1.
Item
Persistent chronic clinically significant non-hematological toxicities from prior treatment must be ≤ Grade 1.
boolean
C1514463 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0205488 (UMLS CUI 2011AA)
57407000 (SNOMED CT 2011_0131)
C2826262 (UMLS CUI 2011AA)
Prior therapy with FLT3 inhibitors is permitted, except previous treatment with AC220.
Item
Prior therapy with FLT3 inhibitors is permitted, except previous treatment with AC220.
boolean
C0521104 (UMLS CUI 2011AA)
75554001 (SNOMED CT 2011_0131)
C1514463 (UMLS CUI 2011AA)
C1333568 (UMLS CUI 2011AA)
C0243077 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
CL374311 (UMLS CUI 2011AA)
Serum creatinine ≤1.5 × ULN and glomerular filtration rate (GFR) > 30 mL/min
Item
Serum creatinine ≤1.5 × ULN and glomerular filtration rate (GFR) > 30 mL/min
boolean
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
C0017654 (UMLS CUI 2011AA)
80274001 (SNOMED CT 2011_0131)
10018355 (MedDRA 14.1)
Serum potassium, magnesium, and calcium levels should be at least within institutional normal limits.
Item
Serum potassium, magnesium, and calcium levels should be at least within institutional normal limits.
boolean
C0580477 (UMLS CUI 2011AA)
166688007 (SNOMED CT 2011_0131)
C0858145 (UMLS CUI 2011AA)
10040338 (MedDRA 14.1)
C0580486 (UMLS CUI 2011AA)
166701009 (SNOMED CT 2011_0131)
Total serum bilirubin ≤1.5 × ULN
Item
Total serum bilirubin ≤1.5 × ULN
boolean
C0428441 (UMLS CUI 2011AA)
166610007 (SNOMED CT 2011_0131)
10040157 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤2.5 × ULN
Item
Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤2.5 × 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)
Females of childbearing potential must have a negative pregnancy test (urine β-hCG).
Item
Females of childbearing potential must have a negative pregnancy test (urine β-hCG).
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)
C0430057 (UMLS CUI 2011AA)
167254001 (SNOMED CT 2011_0131)
10036577 (MedDRA 14.1)
C0106132 (UMLS CUI 2011AA)
40940006 (SNOMED CT 2011_0131)
Females of childbearing potential and sexually mature males must agree to use a medically accepted method of contraception throughout the study.
Item
Females of childbearing potential and sexually mature males must agree to use a medically accepted method of contraception throughout the study.
boolean
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0024554 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0233891 (UMLS CUI 2011AA)
86571001 (SNOMED CT 2011_0131)
C0680240 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Written informed consent must be provided.
Item
Procurement of patient informed consent, investigational study
boolean
C0184704 (UMLS CUI 2011AA)
55149002 (SNOMED CT 2011_0131)
Patients over the age of 85 years except at the discretion of the Investigator and with agreement of the Sponsor.
Item
Alter >85 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Diagnosis of acute promyelocytic leukemia
Item
Diagnosis of acute promyelocytic leukemia
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0023487 (UMLS CUI 2011AA)
110004001 (SNOMED CT 2011_0131)
10001019 (MedDRA 14.1)
C92.4 (ICD-10-CM Version 2010)
Diagnosis of chronic myelogenous leukemia (CML) in blast crisis
Item
Diagnosis of chronic myelogenous leukemia (CML) in blast crisis
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0023473 (UMLS CUI 2011AA)
63364005 (SNOMED CT 2011_0131)
10009700 (MedDRA 14.1)
C92.1 (ICD-10-CM Version 2010)
205.1 (ICD-9-CM Version 2011)
C0005699 (UMLS CUI 2011AA)
278180008 (SNOMED CT 2011_0131)
10053747 (MedDRA 14.1)
AML in relapse or refractory after 3 or more previous lines of chemotherapy (and/or HSCT) treatment
Item
AML in relapse or refractory after 3 or more previous lines of chemotherapy (and/or HSCT) treatment
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)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C0205269 (UMLS CUI 2011AA)
20646008 (SNOMED CT 2011_0131)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C2242529 (UMLS CUI 2011AA)
10067862 (MedDRA 14.1)
AML or antecedent MDS secondary to prior chemotherapy
Item
AML or antecedent MDS secondary to prior chemotherapy
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)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0026986 (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)
C0175668 (UMLS CUI 2011AA)
2603003 (SNOMED CT 2011_0131)
C1514457 (UMLS CUI 2011AA)
Persistent clinically significant non-hematological toxicity that is Grade >1 by NCI CTCAE v4 from prior chemotherapy
Item
Persistent clinically significant non-hematological toxicity that is Grade >1 by NCI CTCAE v4 from prior chemotherapy
boolean
C1514457 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0205488 (UMLS CUI 2011AA)
57407000 (SNOMED CT 2011_0131)
C0040539 (UMLS CUI 2011AA)
C1513374 (UMLS CUI 2011AA)
C1519275 (UMLS CUI 2011AA)
Patients who have had HSCT and are within 100 days of transplant and/or are still taking immunosuppressive drugs and/or have clinically significant graft-versus-host disease requiring treatment and/or have >Grade 1 persistent non hematological toxicity related to the transplant
Item
Patients who have had HSCT and are within 100 days of transplant and/or are still taking immunosuppressive drugs and/or have clinically significant graft-versus-host disease requiring treatment and/or have >Grade 1 persistent non hematological toxicity related to the transplant
boolean
C2242529 (UMLS CUI 2011AA)
10067862 (MedDRA 14.1)
C0021081 (UMLS CUI 2011AA)
372823004, 69431002 (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)
C1514873 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0205488 (UMLS CUI 2011AA)
57407000 (SNOMED CT 2011_0131)
C2826262 (UMLS CUI 2011AA)
C0699792 (UMLS CUI 2011AA)
263498003 (SNOMED CT 2011_0131)
C0040732 (UMLS CUI 2011AA)
77465005 (SNOMED CT 2011_0131)
10057677 (MedDRA 14.1)
Clinically active central nervous system (CNS) leukemia. Patients with CNS leukemia, which is controlled, but who are still receiving IT therapy at study entry may be considered eligible and continue receive IT therapy at the discretion of the Investigator and with agreement of the Sponsor.
Item
ZNS-Leukämie
boolean
C1332884 (UMLS CUI 2011AA)
10067299 (SNOMED CT 2011_0131)
Patients who have previously received AC220
Item
Patients who have previously received AC220
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
CL374311 (UMLS CUI 2011AA)
Disseminated intravascular coagulation (DIC) (diagnosis by laboratory or clinical assessment)
Item
Disseminated intravascular coagulation (DIC) (diagnosis by laboratory or clinical assessment)
boolean
C0012739 (UMLS CUI 2011AA)
67406007 (SNOMED CT 2011_0131)
10013442 (MedDRA 14.1)
D65 (ICD-10-CM Version 2010)
286.6 (ICD-9-CM Version 2011)
E10028 (CTCAE 1105E)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
C0582103 (UMLS CUI 2011AA)
225886003 (SNOMED CT 2011_0131)
Major surgery within 4 weeks prior to enrollment in the study
Item
Major surgery within 4 weeks prior to enrollment in the study
boolean
C0679637 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
Radiation therapy within 4 weeks prior to, or concurrent with study
Item
Radiation therapy within 4 weeks prior to, or concurrent with study
boolean
C0034619 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0205420 (UMLS CUI 2011AA)
68405009 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Use of concomitant drugs that prolong QT/QTc interval and/or are CYP3A4 inhibitors are prohibited with the exception of antibiotics, antifungals, and other antimicrobials that are used as standard of care to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the patient.
Item
Use of concomitant drugs that prolong QT/QTc interval and/or are CYP3A4 inhibitors are prohibited with the exception of antibiotics, antifungals, and other antimicrobials that are used as standard of care to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the patient.
boolean
C2347852 (UMLS CUI 2011AA)
C0151878 (UMLS CUI 2011AA)
111975006 (SNOMED CT 2011_0131)
10014387 (MedDRA 14.1)
E12146 (CTCAE 1105E)
C1560305 (UMLS CUI 2011AA)
C0683610 (UMLS CUI 2011AA)
C1142644 (UMLS CUI 2011AA)
422741004 (SNOMED CT 2011_0131)
C0243077 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0003232 (UMLS CUI 2011AA)
255631004 (SNOMED CT 2011_0131)
C0003308 (UMLS CUI 2011AA)
373219008 (SNOMED CT 2011_0131)
C1136254 (UMLS CUI 2011AA)
250428009 (SNOMED CT 2011_0131)
MTHU014499 (LOINC Version 232)
Uncontrolled or significant cardiovascular disease
Item
Uncontrolled or significant cardiovascular disease
boolean
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
Women who are pregnant, lactating, or unwilling to use contraception if of childbearing potential
Item
Women who are pregnant, lactating, or unwilling to use contraception if of childbearing potential
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C2828358 (UMLS CUI 2011AA)
C0558080 (UMLS CUI 2011AA)
225465005 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0750557 (UMLS CUI 2011AA)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
Men who are unwilling to use contraception if their partners are of childbearing potential
Item
Men who are unwilling to use contraception if their partners are of childbearing potential
boolean
C0025266 (UMLS CUI 2011AA)
339947000 (SNOMED CT 2011_0131)
C0558080 (UMLS CUI 2011AA)
225465005 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0750557 (UMLS CUI 2011AA)
C0682323 (UMLS CUI 2011AA)
262043009 (SNOMED CT 2011_0131)
SIGOTHR (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
Active, uncontrolled infection
Item
Active, uncontrolled infection
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
Human immunodeficiency virus positivity
Item
HIV-positiv
boolean
C0019699 (UMLS CUI 2011AA)
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
Active hepatitis B or C or other active liver disease
Item
Active hepatitis B or C or other active liver disease
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0019163 (UMLS CUI 2011AA)
66071002 (SNOMED CT 2011_0131)
10019731 (MedDRA 14.1)
C0019196 (UMLS CUI 2011AA)
50711007 (SNOMED CT 2011_0131)
10019744 (MedDRA 14.1)
B19.20 (ICD-10-CM Version 2010)
070.7 (ICD-9-CM Version 2011)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
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)
History of cancer, except Stage 1 cervix or nonmelanotic skin cancer, with the possible exception of patients in complete remission
Item
History of cancer, except Stage 1 cervix or nonmelanotic skin cancer, with the possible exception of patients in complete remission
boolean
C2735088 (UMLS CUI 2011AA)
MTHU034770 (LOINC Version 232)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0278575 (UMLS CUI 2011AA)
10008345 (MedDRA 14.1)
C0699893 (UMLS CUI 2011AA)
10040810 (MedDRA 14.1)
C1554961 (UMLS CUI 2011AA)
C0677874 (UMLS CUI 2011AA)
103338009 (SNOMED CT 2011_0131)