ID

4365

Description

ODM derived from http://clinicaltrials.gov/show/NCT00989261

Link

http://clinicaltrials.gov/show/NCT00989261

Keywords

Versions (4)
  1. 12/7/13 12/7/13 - Martin Dugas
  2. 3/25/14 3/25/14 - Martin Dugas
  3. 4/17/14 4/17/14 - Julian Varghese
  4. 9/27/21 9/27/21 -
Uploaded on

December 7, 2013

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00989261 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 85 Years
Description

age 18 Years to 85 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Males and females age ≥18 years in second relapse or refractory.
Description

Males and females age ≥18 years in second relapse or refractory.

Data type

boolean

Alias
UMLS CUI 2011AA
C0024554
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C0205436
SNOMED CT 2011_0131
81170007
UMLS CUI 2011AA
C0277556
SNOMED CT 2011_0131
58184002
UMLS CUI 2011AA
C0205269
SNOMED CT 2011_0131
20646008
Males and females age ≥60 years in first relapse or refractory.
Description

Males and females age ≥60 years in first relapse or refractory.

Data type

boolean

Alias
UMLS CUI 2011AA
C0024554
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C0205435
SNOMED CT 2011_0131
255216001
UMLS CUI 2011AA
C0277556
SNOMED CT 2011_0131
58184002
UMLS CUI 2011AA
C0205269
SNOMED CT 2011_0131
20646008
Must have baseline bone marrow sample taken.
Description

Must have baseline bone marrow sample taken.

Data type

boolean

Alias
UMLS CUI 2011AA
C1442488
UMLS CUI 2011AA
C0438737
SNOMED CT 2011_0131
119359002
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.
Description

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.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332437
SNOMED CT 2011_0131
116676008
LOINC Version 232
MTHU008051
UMLS CUI 2011AA
C1301725
SNOMED CT 2011_0131
397934002
UMLS CUI 2011AA
CL414904
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
C0280449
UMLS CUI 2011AA
C0026986
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
C1704788
UMLS CUI 2011AA
C0451584
SNOMED CT 2011_0131
273931002
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C1521733
SNOMED CT 2011_0131
29458008
UMLS CUI 2011AA
C1552617
HL7 V3 2006_05
REV
Able to swallow the liquid study drug.
Description

Able to swallow the liquid study drug.

Data type

boolean

Alias
UMLS CUI 2011AA
C0566356
SNOMED CT 2011_0131
288936000
UMLS CUI 2011AA
C0302908
SNOMED CT 2011_0131
33463005
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
ECOG performance status of 0 to 2
Description

ECOG performance status of 0 to 2

Data type

boolean

Alias
UMLS CUI 2011AA
C1828078
SNOMED CT 2011_0131
425389002
UMLS CUI 2011AA
C1827388
SNOMED CT 2011_0131
422512005
UMLS CUI 2011AA
C1828242
SNOMED CT 2011_0131
422894000
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.
Description

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.

Data type

boolean

Alias
UMLS CUI 2011AA
C1272706
SNOMED CT 2011_0131
385673002
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C1533734
SNOMED CT 2011_0131
416118004
UMLS CUI 2011AA
CL374311
UMLS CUI 2011AA
C0304497
SNOMED CT 2011_0131
373526007
UMLS CUI 2011AA
C2827065
UMLS CUI 2011AA
C1554075
HL7 V3 2006_05
NP
UMLS CUI 2011AA
C0729502
SNOMED CT 2011_0131
312059006
UMLS CUI 2011AA
C0596112
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0020402
SNOMED CT 2011_0131
56602009
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0205527
SNOMED CT 2011_0131
72607000
UMLS CUI 2011AA
C0039798
Persistent chronic clinically significant non-hematological toxicities from prior treatment must be ≤ Grade 1.
Description

Persistent chronic clinically significant non-hematological toxicities from prior treatment must be ≤ Grade 1.

Data type

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0205488
SNOMED CT 2011_0131
57407000
UMLS CUI 2011AA
C2826262
Prior therapy with FLT3 inhibitors is permitted, except previous treatment with AC220.
Description

Prior therapy with FLT3 inhibitors is permitted, except previous treatment with AC220.

Data type

boolean

Alias
UMLS CUI 2011AA
C0521104
SNOMED CT 2011_0131
75554001
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C1333568
UMLS CUI 2011AA
C0243077
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
CL374311
Serum creatinine ≤1.5 × ULN and glomerular filtration rate (GFR) > 30 mL/min
Description

Serum creatinine ≤1.5 × ULN and glomerular filtration rate (GFR) > 30 mL/min

Data type

boolean

Alias
UMLS CUI 2011AA
C0201976
SNOMED CT 2011_0131
113075003
MedDRA 14.1
10040230
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C0017654
SNOMED CT 2011_0131
80274001
MedDRA 14.1
10018355
Serum potassium, magnesium, and calcium levels should be at least within institutional normal limits.
Description

Serum potassium, magnesium, and calcium levels should be at least within institutional normal limits.

Data type

boolean

Alias
UMLS CUI 2011AA
C0580477
SNOMED CT 2011_0131
166688007
UMLS CUI 2011AA
C0858145
MedDRA 14.1
10040338
UMLS CUI 2011AA
C0580486
SNOMED CT 2011_0131
166701009
Total serum bilirubin ≤1.5 × ULN
Description

Total serum bilirubin ≤1.5 × ULN

Data type

boolean

Alias
UMLS CUI 2011AA
C0428441
SNOMED CT 2011_0131
166610007
MedDRA 14.1
10040157
UMLS CUI 2011AA
C1519815
Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤2.5 × ULN
Description

Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤2.5 × ULN

Data type

boolean

Alias
UMLS CUI 2011AA
C0004002
SNOMED CT 2011_0131
26091008
LOINC Version 232
MTHU004883
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C1519815
Females of childbearing potential must have a negative pregnancy test (urine β-hCG).
Description

Females of childbearing potential must have a negative pregnancy test (urine β-hCG).

Data type

boolean

Alias
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C0430057
SNOMED CT 2011_0131
167254001
MedDRA 14.1
10036577
UMLS CUI 2011AA
C0106132
SNOMED CT 2011_0131
40940006
Females of childbearing potential and sexually mature males must agree to use a medically accepted method of contraception throughout the study.
Description

Females of childbearing potential and sexually mature males must agree to use a medically accepted method of contraception throughout the study.

Data type

boolean

Alias
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0024554
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0233891
SNOMED CT 2011_0131
86571001
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
Procurement of patient informed consent, investigational study
Description

Written informed consent must be provided.

Data type

boolean

Alias
UMLS CUI 2011AA
C0184704
SNOMED CT 2011_0131
55149002
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
age >85 Years
Description

Patients over the age of 85 years except at the discretion of the Investigator and with agreement of the Sponsor.

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Diagnosis of acute promyelocytic leukemia
Description

Diagnosis of acute promyelocytic leukemia

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0023487
SNOMED CT 2011_0131
110004001
MedDRA 14.1
10001019
ICD-10-CM Version 2010
C92.4
Diagnosis of chronic myelogenous leukemia (CML) in blast crisis
Description

Diagnosis of chronic myelogenous leukemia (CML) in blast crisis

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0023473
SNOMED CT 2011_0131
63364005
MedDRA 14.1
10009700
ICD-10-CM Version 2010
C92.1
ICD-9-CM Version 2011
205.1
UMLS CUI 2011AA
C0005699
SNOMED CT 2011_0131
278180008
MedDRA 14.1
10053747
AML in relapse or refractory after 3 or more previous lines of chemotherapy (and/or HSCT) treatment
Description

AML in relapse or refractory after 3 or more previous lines of chemotherapy (and/or HSCT) treatment

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
C0277556
SNOMED CT 2011_0131
58184002
UMLS CUI 2011AA
C0205269
SNOMED CT 2011_0131
20646008
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
UMLS CUI 2011AA
C2242529
MedDRA 14.1
10067862
AML or antecedent MDS secondary to prior chemotherapy
Description

AML or antecedent MDS secondary to prior chemotherapy

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
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0026986
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
C0175668
SNOMED CT 2011_0131
2603003
UMLS CUI 2011AA
C1514457
Persistent clinically significant non-hematological toxicity that is Grade >1 by NCI CTCAE v4 from prior chemotherapy
Description

Persistent clinically significant non-hematological toxicity that is Grade >1 by NCI CTCAE v4 from prior chemotherapy

Data type

boolean

Alias
UMLS CUI 2011AA
C1514457
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0205488
SNOMED CT 2011_0131
57407000
UMLS CUI 2011AA
C0040539
UMLS CUI 2011AA
C1513374
UMLS CUI 2011AA
C1519275
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
Description

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

Data type

boolean

Alias
UMLS CUI 2011AA
C2242529
MedDRA 14.1
10067862
UMLS CUI 2011AA
C0021081
SNOMED CT 2011_0131
372823004, 69431002
UMLS CUI 2011AA
C0018133
SNOMED CT 2011_0131
234646005
MedDRA 14.1
10018651
ICD-10-CM Version 2010
D89.813
ICD-9-CM Version 2011
279.50
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0205488
SNOMED CT 2011_0131
57407000
UMLS CUI 2011AA
C2826262
UMLS CUI 2011AA
C0699792
SNOMED CT 2011_0131
263498003
UMLS CUI 2011AA
C0040732
SNOMED CT 2011_0131
77465005
MedDRA 14.1
10057677
Central Nervous System Leukemia
Description

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.

Data type

boolean

Alias
UMLS CUI 2011AA
C1332884
SNOMED CT 2011_0131
10067299
Patients who have previously received AC220
Description

Patients who have previously received AC220

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
CL374311
Disseminated intravascular coagulation (DIC) (diagnosis by laboratory or clinical assessment)
Description

Disseminated intravascular coagulation (DIC) (diagnosis by laboratory or clinical assessment)

Data type

boolean

Alias
UMLS CUI 2011AA
C0012739
SNOMED CT 2011_0131
67406007
MedDRA 14.1
10013442
ICD-10-CM Version 2010
D65
ICD-9-CM Version 2011
286.6
CTCAE 1105E
E10028
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0022877
SNOMED CT 2011_0131
261904005
LOINC Version 232
MTHU029808
UMLS CUI 2011AA
C0582103
SNOMED CT 2011_0131
225886003
Major surgery within 4 weeks prior to enrollment in the study
Description

Major surgery within 4 weeks prior to enrollment in the study

Data type

boolean

Alias
UMLS CUI 2011AA
C0679637
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1516879
Radiation therapy within 4 weeks prior to, or concurrent with study
Description

Radiation therapy within 4 weeks prior to, or concurrent with study

Data type

boolean

Alias
UMLS CUI 2011AA
C0034619
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0205420
SNOMED CT 2011_0131
68405009
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
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.
Description

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.

Data type

boolean

Alias
UMLS CUI 2011AA
C2347852
UMLS CUI 2011AA
C0151878
SNOMED CT 2011_0131
111975006
MedDRA 14.1
10014387
CTCAE 1105E
E12146
UMLS CUI 2011AA
C1560305
UMLS CUI 2011AA
C0683610
UMLS CUI 2011AA
C1142644
SNOMED CT 2011_0131
422741004
UMLS CUI 2011AA
C0243077
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0003232
SNOMED CT 2011_0131
255631004
UMLS CUI 2011AA
C0003308
SNOMED CT 2011_0131
373219008
UMLS CUI 2011AA
C1136254
SNOMED CT 2011_0131
250428009
LOINC Version 232
MTHU014499
Uncontrolled or significant cardiovascular disease
Description

Uncontrolled or significant cardiovascular disease

Data type

boolean

Alias
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0007222
SNOMED CT 2011_0131
105980002
MedDRA 14.1
10007649
ICD-9-CM Version 2011
429.2
Women who are pregnant, lactating, or unwilling to use contraception if of childbearing potential
Description

Women who are pregnant, lactating, or unwilling to use contraception if of childbearing potential

Data type

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C2828358
UMLS CUI 2011AA
C0558080
SNOMED CT 2011_0131
225465005
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
Men who are unwilling to use contraception if their partners are of childbearing potential
Description

Men who are unwilling to use contraception if their partners are of childbearing potential

Data type

boolean

Alias
UMLS CUI 2011AA
C0025266
SNOMED CT 2011_0131
339947000
UMLS CUI 2011AA
C0558080
SNOMED CT 2011_0131
225465005
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C0682323
SNOMED CT 2011_0131
262043009
HL7 V3 2006_05
SIGOTHR
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
Active, uncontrolled infection
Description

Active, uncontrolled infection

Data type

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0021311
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
HIV Seropositivity
Description

Human immunodeficiency virus positivity

Data type

boolean

Alias
UMLS CUI 2011AA
C0019699
SNOMED CT 2011_0131
165816005
MedDRA 14.1
10020188
ICD-10-CM Version 2010
Z21
Active hepatitis B or C or other active liver disease
Description

Active hepatitis B or C or other active liver disease

Data type

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0019163
SNOMED CT 2011_0131
66071002
MedDRA 14.1
10019731
UMLS CUI 2011AA
C0019196
SNOMED CT 2011_0131
50711007
MedDRA 14.1
10019744
ICD-10-CM Version 2010
B19.20
ICD-9-CM Version 2011
070.7
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0023895
SNOMED CT 2011_0131
235856003
MedDRA 14.1
10024670
ICD-10-CM Version 2010
K76.9
ICD-9-CM Version 2011
573.9
History of cancer, except Stage 1 cervix or nonmelanotic skin cancer, with the possible exception of patients in complete remission
Description

History of cancer, except Stage 1 cervix or nonmelanotic skin cancer, with the possible exception of patients in complete remission

Data type

boolean

Alias
UMLS CUI 2011AA
C2735088
LOINC Version 232
MTHU034770
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0278575
MedDRA 14.1
10008345
UMLS CUI 2011AA
C0699893
MedDRA 14.1
10040810
UMLS CUI 2011AA
C1554961
UMLS CUI 2011AA
C0677874
SNOMED CT 2011_0131
103338009
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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 85 Years
Item
age 18 Years to 85 Years
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)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Patients over the age of 85 years except at the discretion of the Investigator and with agreement of the Sponsor.
Item
age >85 Years
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
Central Nervous System Leukemia
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 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, 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)
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