ID

44582

Description

Phase 2 Open-Label, AC220 Monotherapy Efficacy (ACE) Study in Patients With Acute Myeloid Leukemia (AML) With and Without FLT3-ITD Activating Mutations see 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

September 27, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00989261 Acute Myeloid Leukemia

German English

Eligibility AML NCT00989261

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility AML NCT00989261
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
SNOMED CT 2011_0131
397669002
UMLS CUI-1
C0001779
Males and females age ≥18 years in second relapse or refractory.
Description

Age 18+ and in second relapse or refractory

Data type

boolean

Alias
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
SNOMED CT 2011_0131
397669002
SNOMED CT 2011_0131
81170007
SNOMED CT 2011_0131
58184002
SNOMED CT 2011_0131
20646008
UMLS CUI-1
C0001779
UMLS CUI-2
C0205436
UMLS CUI-3
C0277556
UMLS CUI-4
C0205269
Males and females age ≥60 years in first relapse or refractory.
Description

Age 60+ in first relapse or refractory.

Data type

boolean

Alias
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
SNOMED CT 2011_0131
397669002
SNOMED CT 2011_0131
255216001
SNOMED CT 2011_0131
58184002
SNOMED CT 2011_0131
20646008
UMLS CUI-1
C0001779
UMLS CUI-2
C0205435
UMLS CUI-3
C0277556
UMLS CUI-4
C0205269
Must have baseline bone marrow sample taken.
Description

Baseline bone marrow sample

Data type

boolean

Alias
SNOMED CT 2011_0131
119359002
UMLS CUI-1
C1442488
UMLS CUI-2
C0438737
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

Primary AML or AML secondary to MDS

Data type

boolean

Alias
SNOMED CT 2011_0131
116676008
LOINC Version 232
MTHU008051
SNOMED CT 2011_0131
397934002
SNOMED CT 2011_0131
91861009
MedDRA 14.1
10000880
ICD-10-CM Version 2010
C92.0
ICD-9-CM Version 2011
205.0
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
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
SNOMED CT 2011_0131
273931002
SNOMED CT 2011_0131
29458008
HL7 V3 2006_05
REV
UMLS CUI-1
C0332437
UMLS CUI-2
C1301725
UMLS CUI-3
CL414904
UMLS CUI-4
C0023467
UMLS CUI-5
C0280449
UMLS CUI-6
C3463824
UMLS CUI-7
C0750484
UMLS CUI-8
C1521733
Able to swallow the liquid study drug.
Description

Able to swallow study drug

Data type

boolean

Alias
SNOMED CT 2011_0131
288936000
SNOMED CT 2011_0131
33463005
SNOMED CT 2011_0131
902003
UMLS CUI-1
C2712086
UMLS CUI-2
C0304229
ECOG performance status of 0 to 2
Description

ECOG status 0-2

Data type

boolean

Alias
UMLS CUI-1
C1520224
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

Prior therapy

Data type

boolean

Alias
SNOMED CT 2011_0131
385673002
SNOMED CT 2011_0131
416118004
SNOMED CT 2011_0131
373526007
HL7 V3 2006_05
NP
SNOMED CT 2011_0131
312059006
SNOMED CT 2011_0131
56602009
HL7 V3 2006_05
E
SNOMED CT 2011_0131
72607000
UMLS CUI-1
C1514463
Persistent chronic clinically significant non-hematological toxicities from prior treatment must be <= Grade 1.
Description

Persistent non-hematological toxicities <= Grade 1.

Data type

boolean

Alias
SNOMED CT 2011_0131
57407000
UMLS CUI-1
C1514463
UMLS CUI-2
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
SNOMED CT 2011_0131
75554001
HL7 V3 2006_05
E
UMLS CUI-1
C0521104
UMLS CUI-2
C1514463
UMLS CUI-3
C1333568
UMLS CUI-4
C0243077
UMLS CUI-5
C1554961
UMLS CUI-6
CL374311
Serum creatinine ≤1.5 × ULN and glomerular filtration rate (GFR) > 30 mL/min
Description

Serum creatinine and GFR

Data type

boolean

Alias
SNOMED CT 2011_0131
113075003
MedDRA 14.1
10040230
SNOMED CT 2011_0131
80274001
MedDRA 14.1
10018355
UMLS CUI-1
C0201976
UMLS CUI-2
C0017654
Serum potassium, magnesium, and calcium levels should be at least within institutional normal limits.
Description

Serum potassium, magnesium, and calcium normal

Data type

boolean

Alias
SNOMED CT 2011_0131
166688007
MedDRA 14.1
10040338
SNOMED CT 2011_0131
166701009
UMLS CUI-1
C0580477
UMLS CUI-2
C0858145
UMLS CUI-3
C0580486
Total serum bilirubin ≤1.5 × ULN
Description

Serum bilirubin

Data type

boolean

Alias
SNOMED CT 2011_0131
166610007
MedDRA 14.1
10040157
UMLS CUI-1
C1278039
Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤2.5 × ULN
Description

AST and ALT

Data type

boolean

Alias
SNOMED CT 2011_0131
26091008
LOINC Version 232
MTHU004883
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI-1
C0004002
UMLS CUI-2
C0001899
Females of childbearing potential must have a negative pregnancy test (urine β-hCG).
Description

Negative pregnancy test

Data type

boolean

Alias
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
SNOMED CT 2011_0131
410525008
SNOMED CT 2011_0131
167254001
MedDRA 14.1
10036577
SNOMED CT 2011_0131
40940006
UMLS CUI-1
C0430057
Females of childbearing potential and sexually mature males must agree to use a medically accepted method of contraception throughout the study.
Description

Contraception

Data type

boolean

Alias
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
SNOMED CT 2011_0131
86571001
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI-1
C0700589
Procurement of patient informed consent, investigational study
Description

Written informed consent

Data type

boolean

Alias
SNOMED CT 2011_0131
55149002
UMLS CUI-1
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Patients over the age of 85 years except at the discretion of the Investigator and with agreement of the Sponsor.
Description

Age

Data type

boolean

Alias
SNOMED CT 2011_0131
397669002
UMLS CUI-1
C0001779
Diagnosis of acute promyelocytic leukemia
Description

Acute promyelocytic leukemia

Data type

boolean

Alias
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
SNOMED CT 2011_0131
110004001
MedDRA 14.1
10001019
ICD-10-CM Version 2010
C92.4
UMLS CUI-1
C0023487
Diagnosis of chronic myelogenous leukemia (CML) in blast crisis
Description

CML in blast crisis

Data type

boolean

Alias
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
SNOMED CT 2011_0131
63364005
MedDRA 14.1
10009700
ICD-10-CM Version 2010
C92.1
ICD-9-CM Version 2011
205.1
SNOMED CT 2011_0131
278180008
MedDRA 14.1
10053747
UMLS CUI-1
C0023473
UMLS CUI-2
C0005699
AML in relapse or refractory after 3 or more previous lines of chemotherapy (and/or HSCT) treatment
Description

AML in relapse or refractory

Data type

boolean

Alias
SNOMED CT 2011_0131
91861009
MedDRA 14.1
10000880
ICD-10-CM Version 2010
C92.0
ICD-9-CM Version 2011
205.0
SNOMED CT 2011_0131
58184002
SNOMED CT 2011_0131
20646008
SNOMED CT 2011_0131
237679004
SNOMED CT 2011_0131
150415003
MedDRA 14.1
10067862
UMLS CUI-1
C0023467
UMLS CUI-2
C0277556
UMLS CUI-3
C0205269
AML or antecedent MDS secondary to prior chemotherapy
Description

AML or antecedent MDS secondary to prior chemotherapy

Data type

boolean

Alias
SNOMED CT 2011_0131
91861009
MedDRA 14.1
10000880
ICD-10-CM Version 2010
C92.0
ICD-9-CM Version 2011
205.0
SNOMED CT 2011_0131
288556008
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
SNOMED CT 2011_0131
2603003
UMLS CUI-1
C0023467
UMLS CUI-2
C3463824
UMLS CUI-3
C0175668
UMLS CUI-4
C1514457
Persistent clinically significant non-hematological toxicity that is Grade >1 by NCI CTCAE v4 from prior chemotherapy
Description

non-hematological toxicity Grade >1 from prior chemotherapy

Data type

boolean

Alias
SNOMED CT 2011_0131
57407000
UMLS CUI-1
C1514457
UMLS CUI-2
C0040539
UMLS CUI-3
C1513374
UMLS CUI-4
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

HSCT, GVHD, toxicity

Data type

boolean

Alias
MedDRA 14.1
10067862
SNOMED CT 2011_0131
372823004, 69431002
SNOMED CT 2011_0131
234646005
MedDRA 14.1
10018651
ICD-10-CM Version 2010
D89.813
ICD-9-CM Version 2011
279.50
SNOMED CT 2011_0131
57407000
SNOMED CT 2011_0131
263498003
SNOMED CT 2011_0131
77465005
MedDRA 14.1
10057677
UMLS CUI-1
C2242529
UMLS CUI-2
C0021081
UMLS CUI-3
C0018133
UMLS CUI-4
C2826262
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.
Description

Central Nervous System Leukemia

Data type

boolean

Alias
SNOMED CT 2011_0131
10067299
UMLS CUI-1
C1332884
Patients who have previously received AC220
Description

previously received AC220

Data type

boolean

Alias
SNOMED CT 2011_0131
9130008
UMLS CUI-1
C0205156
UMLS CUI-2
C1514756
UMLS CUI-3
CL374311
Disseminated intravascular coagulation (DIC) (diagnosis by laboratory or clinical assessment)
Description

Disseminated intravascular coagulation

Data type

boolean

Alias
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
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
SNOMED CT 2011_0131
261904005
LOINC Version 232
MTHU029808
SNOMED CT 2011_0131
225886003
UMLS CUI-1
C0012739
Major surgery within 4 weeks prior to enrollment in the study
Description

Major surgery within 4 weeks prior to enrollment

Data type

boolean

Alias
SNOMED CT 2011_0131
288556008
UMLS CUI-1
C0679637
UMLS CUI-2
C0332152
UMLS CUI-3
C1516879
Radiation therapy within 4 weeks prior to, or concurrent with study
Description

Radiotherapy

Data type

boolean

Alias
SNOMED CT 2011_0131
288556008
SNOMED CT 2011_0131
68405009
SNOMED CT 2011_0131
110465008
UMLS CUI-1
C0034619
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

QT interval, CYP3A4 inhibitors

Data type

boolean

Alias
SNOMED CT 2011_0131
111975006
MedDRA 14.1
10014387
CTCAE 1105E
E12146
SNOMED CT 2011_0131
422741004
HL7 V3 2006_05
E
SNOMED CT 2011_0131
255631004
SNOMED CT 2011_0131
373219008
SNOMED CT 2011_0131
250428009
LOINC Version 232
MTHU014499
UMLS CUI-1
C2347852
UMLS CUI-2
C0151878
UMLS CUI-3
C1560305
UMLS CUI-4
C1142644
UMLS CUI-5
C0243077
Uncontrolled or significant cardiovascular disease
Description

Cardiovascular disease

Data type

boolean

Alias
SNOMED CT 2011_0131
19032002
SNOMED CT 2011_0131
386134007
SNOMED CT 2011_0131
105980002
MedDRA 14.1
10007649
ICD-9-CM Version 2011
429.2
UMLS CUI-1
C0007222
Women who are pregnant, lactating, or unwilling to use contraception if of childbearing potential
Description

Pregnant, lactating, or unwilling to use contraception

Data type

boolean

Alias
SNOMED CT 2011_0131
224526002
MedDRA 14.1
10036586
SNOMED CT 2011_0131
225465005
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI-1
C0549206
UMLS CUI-2
C2828358
UMLS CUI-3
C0558080
UMLS CUI-4
C0700589
Men who are unwilling to use contraception if their partners are of childbearing potential
Description

Men who are unwilling to use contraception

Data type

boolean

Alias
SNOMED CT 2011_0131
339947000
SNOMED CT 2011_0131
225465005
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
SNOMED CT 2011_0131
262043009
HL7 V3 2006_05
SIGOTHR
UMLS CUI-1
C0025266
UMLS CUI-2
C0558080
UMLS CUI-3
C0700589
Active, uncontrolled infection
Description

Active, uncontrolled infection

Data type

boolean

Alias
UMLS CUI-1
C0205177
UMLS CUI-2
C0205318
UMLS CUI-3
C0009450
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

Data type

boolean

Alias
LOINC Version 232
MTHU034770
HL7 V3 2006_05
E
MedDRA 14.1
10008345
MedDRA 14.1
10040810
SNOMED CT 2011_0131
103338009
UMLS CUI-1
C2735088
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Similar models

Eligibility AML NCT00989261

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility AML NCT00989261
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
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)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
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)
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