AML
Item
cytological confirmation of AML
boolean
Relapse
Item
relapsed disease following first CR of 1 month(30days) to 24 months(730days). The time from first relapse to study entry (start of first course of induction chemotherapy) must be no longer than 30days
boolean
FLT-3 mutation
Item
confirmation of FLT-3 activating mutation positive status after point of initial relapse
boolean
Age
Item
aged 18 years or older
boolean
Life expectancy
Item
no comorbid conditions that would limit life expectancy to less than 3 months
boolean
ECOG
Item
ECOG Performance Score of 0, 1,or 2
boolean
Pregnancy / Lactation
Item
women must be neither pregnant nor lactating, and either of non-childbearing potential or using adequate contraception with a negative pregnancy test at study entry
boolean
Bilirubin
Item
bilirubin > 2x ULN
boolean
ALT / AST
Item
ALT/AST > 3x ULN
boolean
Serum creatinine
Item
serum creatinine > 1.5 mg/dL
boolean
Ejection fraction
Item
resting ejection fraction of left ventricle l < 45% (applies only to patients scheduled to receive mitoxantrone, etoposide, and cytarabine (MEC)
boolean
Infection
Item
untreated or progressive infection
boolean
Major physical or psychiatric condition
Item
any physical or psychiatric condition that may compromise participation in the study
boolean
CNS involvement
Item
known CNS involvement with AML
boolean
Previous FLT-3 inhibitor
Item
any previous treatment with a FLT-3 inhibitor
boolean
HIV treatment
Item
requires current treatment for HIV with protease inhibitors
boolean
Gastrointestinal ulceration or bleeding
Item
active GI ulceration or bleeding
boolean
Other investigational drug
Item
use of an investigational drug that is not expected to be cleared by the start of CEP-701 treatment
boolean
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
AML
Item
Acute myeloid leukemia
string
C0023467 (UMLS CUI)
91861009 (SNOMED CT 2010_0731)
10000884 (MedDRA 13.1)
Relapse
Item
Relapse phase
string
C0035020 (UMLS CUI)
263855007 (SNOMED CT 2010_0731)
10000884 (MedDRA 13.1)
FLT3 gene mutation analysis
Item
FLT3 gene mutation analysis
string
C1953284 (UMLS CUI)
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Compliance
Item
Compliance behavior
string
C1321605 (UMLS CUI)
405078008 (SNOMED CT 2010_0731)
Life expectancy
Item
Life expectancy
string
C0023671 (UMLS CUI)
LP75025-4 (LOINC Version 232)
ECOG performance status
Item
ECOG performance status
string
423740007 (SNOMED CT 2010_0731)
pregnant
Item
pregnant
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Lactation
Item
Breast feeding
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
Bilirubin
Item
Bilirubin
string
79706000 (SNOMED CT 2010_0731)
C0011221 (UMLS CUI)
10004683 (MedDRA Version 13.1)
1975-2 (LOINC)
AST
Item
Glutamate oxaloacetate transaminase (GOT) = Aspartate Transaminase (AST)
string
26091008 (SNOMED CT 2010_0731)
C0004002 (UMLS CUI)
10003543 (MedDRA Version 13.1)
1920-8 (LOINC)
ALT
Item
Alanine Transaminase (ALT) = glutamate pyruvate transaminase (GPT)
string
56935002 (SNOMED CT 2010_0731)
C0001899 (UMLS CUI)
10001844 (MedDRA Version 13.1)
1742-6 (LOINC)
Creatinine
Item
Creatinine
string
C0010294 (UMLS CUI)
15373003 (SNOMED CT 2010_0731)
38483-4 (LOINC)
10011358 (MedDRA 13.1)
Cardiac ejection fraction
Item
Ejection fraction
string
C0232174 (UMLS CUI)
70822001 (SNOMED CT 2010_0731)
Infection
Item
Infection
string
C0021311 (UMLS CUI)
257551009 (SNOMED CT 2010_0731)
10021789 (MedDRA Version 13.1)
CNS involvement
Item
CNS involvement status
string
C0449389 (UMLS CUI)
260766009 (SNOMED CT 2010_0731)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
HIV negative
Item
HIV negative
string
C0481430 (UMLS CUI)
143223008 (SNOMED CT 2010_0731)
Gastrointestinal ulcer
Item
Gastrointestinal ulcer
string
C0237938 (UMLS CUI)
40845000 (SNOMED CT 2010_0731)
10061459 (MedDRA Version 13.1)
Gastrointestinal hemorrhage
Item
Gastrointestinal bleeding
string
C0017181 (UMLS CUI)
74474003 (SNOMED CT 2010_0731)
10017936 (MedDRA Version 13.1)
Enrollment
Item
Enrollment
string
C1516879 (UMLS CUI)