age 18 Years to 85 Years
Item
age 18 Years to 85 Years
boolean
397669002 (SNOMED CT 2011_0131)
C0001779 (UMLS CUI-1)
Age 18+ and in second relapse or refractory
Item
Males and females age ≥18 years in second relapse or refractory.
boolean
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
397669002 (SNOMED CT 2011_0131)
81170007 (SNOMED CT 2011_0131)
58184002 (SNOMED CT 2011_0131)
20646008 (SNOMED CT 2011_0131)
C0001779 (UMLS CUI-1)
C0205436 (UMLS CUI-2)
C0277556 (UMLS CUI-3)
C0205269 (UMLS CUI-4)
Age 60+ in first relapse or refractory.
Item
Males and females age ≥60 years in first relapse or refractory.
boolean
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
397669002 (SNOMED CT 2011_0131)
255216001 (SNOMED CT 2011_0131)
58184002 (SNOMED CT 2011_0131)
20646008 (SNOMED CT 2011_0131)
C0001779 (UMLS CUI-1)
C0205435 (UMLS CUI-2)
C0277556 (UMLS CUI-3)
C0205269 (UMLS CUI-4)
Baseline bone marrow sample
Item
Must have baseline bone marrow sample taken.
boolean
119359002 (SNOMED CT 2011_0131)
C1442488 (UMLS CUI-1)
C0438737 (UMLS CUI-2)
Primary AML or AML secondary to MDS
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
116676008 (SNOMED CT 2011_0131)
MTHU008051 (LOINC Version 232)
397934002 (SNOMED CT 2011_0131)
91861009 (SNOMED CT 2011_0131)
10000880 (MedDRA 14.1)
C92.0 (ICD-10-CM Version 2010)
205.0 (ICD-9-CM Version 2011)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
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)
273931002 (SNOMED CT 2011_0131)
29458008 (SNOMED CT 2011_0131)
REV (HL7 V3 2006_05)
C0332437 (UMLS CUI-1)
C1301725 (UMLS CUI-2)
CL414904 (UMLS CUI-3)
C0023467 (UMLS CUI-4)
C0280449 (UMLS CUI-5)
C3463824 (UMLS CUI-6)
C0750484 (UMLS CUI-7)
C1521733 (UMLS CUI-8)
Able to swallow study drug
Item
Able to swallow the liquid study drug.
boolean
288936000 (SNOMED CT 2011_0131)
33463005 (SNOMED CT 2011_0131)
902003 (SNOMED CT 2011_0131)
C2712086 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
ECOG status 0-2
Item
ECOG performance status of 0 to 2
boolean
C1520224 (UMLS CUI-1)
Prior therapy
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
385673002 (SNOMED CT 2011_0131)
416118004 (SNOMED CT 2011_0131)
373526007 (SNOMED CT 2011_0131)
NP (HL7 V3 2006_05)
312059006 (SNOMED CT 2011_0131)
56602009 (SNOMED CT 2011_0131)
E (HL7 V3 2006_05)
72607000 (SNOMED CT 2011_0131)
C1514463 (UMLS CUI-1)
Persistent non-hematological toxicities <= Grade 1.
Item
Persistent chronic clinically significant non-hematological toxicities from prior treatment must be <= Grade 1.
boolean
57407000 (SNOMED CT 2011_0131)
C1514463 (UMLS CUI-1)
C2826262 (UMLS CUI-2)
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
75554001 (SNOMED CT 2011_0131)
E (HL7 V3 2006_05)
C0521104 (UMLS CUI-1)
C1514463 (UMLS CUI-2)
C1333568 (UMLS CUI-3)
C0243077 (UMLS CUI-4)
C1554961 (UMLS CUI-5)
CL374311 (UMLS CUI-6)
Serum creatinine and GFR
Item
Serum creatinine ≤1.5 × ULN and glomerular filtration rate (GFR) > 30 mL/min
boolean
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
80274001 (SNOMED CT 2011_0131)
10018355 (MedDRA 14.1)
C0201976 (UMLS CUI-1)
C0017654 (UMLS CUI-2)
Serum potassium, magnesium, and calcium normal
Item
Serum potassium, magnesium, and calcium levels should be at least within institutional normal limits.
boolean
166688007 (SNOMED CT 2011_0131)
10040338 (MedDRA 14.1)
166701009 (SNOMED CT 2011_0131)
C0580477 (UMLS CUI-1)
C0858145 (UMLS CUI-2)
C0580486 (UMLS CUI-3)
Serum bilirubin
Item
Total serum bilirubin ≤1.5 × ULN
boolean
166610007 (SNOMED CT 2011_0131)
10040157 (MedDRA 14.1)
C1278039 (UMLS CUI-1)
AST and ALT
Item
Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤2.5 × ULN
boolean
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C0004002 (UMLS CUI-1)
C0001899 (UMLS CUI-2)
Negative pregnancy test
Item
Females of childbearing potential must have a negative pregnancy test (urine β-hCG).
boolean
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
410525008 (SNOMED CT 2011_0131)
167254001 (SNOMED CT 2011_0131)
10036577 (MedDRA 14.1)
40940006 (SNOMED CT 2011_0131)
C0430057 (UMLS CUI-1)
Contraception
Item
Females of childbearing potential and sexually mature males must agree to use a medically accepted method of contraception throughout the study.
boolean
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
86571001 (SNOMED CT 2011_0131)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0700589 (UMLS CUI-1)
Written informed consent
Item
Procurement of patient informed consent, investigational study
boolean
55149002 (SNOMED CT 2011_0131)
C0021430 (UMLS CUI-1)
Age
Item
Patients over the age of 85 years except at the discretion of the Investigator and with agreement of the Sponsor.
boolean
397669002 (SNOMED CT 2011_0131)
C0001779 (UMLS CUI-1)
Acute promyelocytic leukemia
Item
Diagnosis of acute promyelocytic leukemia
boolean
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
110004001 (SNOMED CT 2011_0131)
10001019 (MedDRA 14.1)
C92.4 (ICD-10-CM Version 2010)
C0023487 (UMLS CUI-1)
CML in blast crisis
Item
Diagnosis of chronic myelogenous leukemia (CML) in blast crisis
boolean
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
63364005 (SNOMED CT 2011_0131)
10009700 (MedDRA 14.1)
C92.1 (ICD-10-CM Version 2010)
205.1 (ICD-9-CM Version 2011)
278180008 (SNOMED CT 2011_0131)
10053747 (MedDRA 14.1)
C0023473 (UMLS CUI-1)
C0005699 (UMLS CUI-2)
AML in relapse or refractory
Item
AML in relapse or refractory after 3 or more previous lines of chemotherapy (and/or HSCT) treatment
boolean
91861009 (SNOMED CT 2011_0131)
10000880 (MedDRA 14.1)
C92.0 (ICD-10-CM Version 2010)
205.0 (ICD-9-CM Version 2011)
58184002 (SNOMED CT 2011_0131)
20646008 (SNOMED CT 2011_0131)
237679004 (SNOMED CT 2011_0131)
150415003 (SNOMED CT 2011_0131)
10067862 (MedDRA 14.1)
C0023467 (UMLS CUI-1)
C0277556 (UMLS CUI-2)
C0205269 (UMLS CUI-3)
AML or antecedent MDS secondary to prior chemotherapy
Item
AML or antecedent MDS secondary to prior chemotherapy
boolean
91861009 (SNOMED CT 2011_0131)
10000880 (MedDRA 14.1)
C92.0 (ICD-10-CM Version 2010)
205.0 (ICD-9-CM Version 2011)
288556008 (SNOMED CT 2011_0131)
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)
2603003 (SNOMED CT 2011_0131)
C0023467 (UMLS CUI-1)
C3463824 (UMLS CUI-2)
C0175668 (UMLS CUI-3)
C1514457 (UMLS CUI-4)
non-hematological toxicity Grade >1 from prior chemotherapy
Item
Persistent clinically significant non-hematological toxicity that is Grade >1 by NCI CTCAE v4 from prior chemotherapy
boolean
57407000 (SNOMED CT 2011_0131)
C1514457 (UMLS CUI-1)
C0040539 (UMLS CUI-2)
C1513374 (UMLS CUI-3)
C1519275 (UMLS CUI-4)
HSCT, GVHD, toxicity
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
10067862 (MedDRA 14.1)
372823004, 69431002 (SNOMED CT 2011_0131)
234646005 (SNOMED CT 2011_0131)
10018651 (MedDRA 14.1)
D89.813 (ICD-10-CM Version 2010)
279.50 (ICD-9-CM Version 2011)
57407000 (SNOMED CT 2011_0131)
263498003 (SNOMED CT 2011_0131)
77465005 (SNOMED CT 2011_0131)
10057677 (MedDRA 14.1)
C2242529 (UMLS CUI-1)
C0021081 (UMLS CUI-2)
C0018133 (UMLS CUI-3)
C2826262 (UMLS CUI-4)
Central Nervous System Leukemia
Item
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.
boolean
10067299 (SNOMED CT 2011_0131)
C1332884 (UMLS CUI-1)
previously received AC220
Item
Patients who have previously received AC220
boolean
9130008 (SNOMED CT 2011_0131)
C0205156 (UMLS CUI-1)
C1514756 (UMLS CUI-2)
CL374311 (UMLS CUI-3)
Disseminated intravascular coagulation
Item
Disseminated intravascular coagulation (DIC) (diagnosis by laboratory or clinical assessment)
boolean
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)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
225886003 (SNOMED CT 2011_0131)
C0012739 (UMLS CUI-1)
Major surgery within 4 weeks prior to enrollment
Item
Major surgery within 4 weeks prior to enrollment in the study
boolean
288556008 (SNOMED CT 2011_0131)
C0679637 (UMLS CUI-1)
C0332152 (UMLS CUI-2)
C1516879 (UMLS CUI-3)
Radiotherapy
Item
Radiation therapy within 4 weeks prior to, or concurrent with study
boolean
288556008 (SNOMED CT 2011_0131)
68405009 (SNOMED CT 2011_0131)
110465008 (SNOMED CT 2011_0131)
C0034619 (UMLS CUI-1)
QT interval, CYP3A4 inhibitors
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
111975006 (SNOMED CT 2011_0131)
10014387 (MedDRA 14.1)
E12146 (CTCAE 1105E)
422741004 (SNOMED CT 2011_0131)
E (HL7 V3 2006_05)
255631004 (SNOMED CT 2011_0131)
373219008 (SNOMED CT 2011_0131)
250428009 (SNOMED CT 2011_0131)
MTHU014499 (LOINC Version 232)
C2347852 (UMLS CUI-1)
C0151878 (UMLS CUI-2)
C1560305 (UMLS CUI-3)
C1142644 (UMLS CUI-4)
C0243077 (UMLS CUI-5)
Cardiovascular disease
Item
Uncontrolled or significant cardiovascular disease
boolean
19032002 (SNOMED CT 2011_0131)
386134007 (SNOMED CT 2011_0131)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
C0007222 (UMLS CUI-1)
Pregnant, lactating, or unwilling to use contraception
Item
Women who are pregnant, lactating, or unwilling to use contraception if of childbearing potential
boolean
224526002 (SNOMED CT 2011_0131)
10036586 (MedDRA 14.1)
225465005 (SNOMED CT 2011_0131)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0549206 (UMLS CUI-1)
C2828358 (UMLS CUI-2)
C0558080 (UMLS CUI-3)
C0700589 (UMLS CUI-4)
Men who are unwilling to use contraception
Item
Men who are unwilling to use contraception if their partners are of childbearing potential
boolean
339947000 (SNOMED CT 2011_0131)
225465005 (SNOMED CT 2011_0131)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
262043009 (SNOMED CT 2011_0131)
SIGOTHR (HL7 V3 2006_05)
C0025266 (UMLS CUI-1)
C0558080 (UMLS CUI-2)
C0700589 (UMLS CUI-3)
Active, uncontrolled infection
Item
Active, uncontrolled infection
boolean
C0205177 (UMLS CUI-1)
C0205318 (UMLS CUI-2)
C0009450 (UMLS CUI-3)
Human immunodeficiency virus positivity
Item
HIV Seropositivity
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
Item
History of cancer, except Stage 1 cervix or nonmelanotic skin cancer, with the possible exception of patients in complete remission
boolean
MTHU034770 (LOINC Version 232)
E (HL7 V3 2006_05)
10008345 (MedDRA 14.1)
10040810 (MedDRA 14.1)
103338009 (SNOMED CT 2011_0131)
C2735088 (UMLS CUI-1)