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Information:
Fel:
ID
4745
Beskrivning
Study of CEP-701 in Patients With Acute Myeloid Leukemia (AML) See http://clinicaltrials.gov/ct2/show/study/NCT00079482
Länk
http://clinicaltrials.gov/ct2/show/study/NCT00079482
Nyckelord
Versioner (3)
- 2011-11-18 2011-11-18 -
- 2014-03-26 2014-03-26 - Martin Dugas
- 2021-09-17 2021-09-17 -
Uppladdad den
26 mars 2014
DOI
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Licens
Creative Commons BY 4.0
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Eligibility NCT00079482 AML
Eligibility AML NCT00079482
- StudyEvent: Eligibility
Similar models
Eligibility AML NCT00079482
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
AML
Item
cytological confirmation of AML
boolean
C0023467 (UMLS CUI-1)
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
C0277556 (UMLS CUI-1)
FLT3 mutation
Item
confirmation of FLT-3 activating mutation positive status after point of initial relapse
boolean
C2348501 (UMLS CUI-1)
Age
Item
aged 18 years or older
boolean
C0001779 (UMLS CUI-1)
Life expectancy
Item
no comorbid conditions that would limit life expectancy to less than 3 months
boolean
C0023671 (UMLS CUI-1)
ECOG
Item
ECOG Performance Score of 0, 1,or 2
boolean
C1828127 (UMLS CUI-1)
Not pregnant nor lactating
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
C0232973 (UMLS CUI-1)
C1518422 (UMLS CUI-2)
C0006147 (UMLS CUI-3)
C1518422 (UMLS CUI-2)
C0006147 (UMLS CUI-3)
Bilirubin
Item
bilirubin > 2x ULN
boolean
C0201913 (UMLS CUI-1)
ALT and AST
Item
ALT/AST > 3x ULN
boolean
C0001899 (UMLS CUI-1)
C0004002 (UMLS CUI-2)
C0004002 (UMLS CUI-2)
Serum creatinine
Item
serum creatinine > 1.5 mg/dL
boolean
C0201976 (UMLS CUI-1)
Ejection fraction (EF)
Item
resting ejection fraction of left ventricle < 45% (applies only to patients scheduled to receive mitoxantrone, etoposide, and cytarabine (MEC))
boolean
C0232174 (UMLS CUI-1)
Infection
Item
untreated or progressive infection
boolean
C0021311 (UMLS CUI-1)
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
C0449389 (UMLS CUI-1)
FLT3 inhibitor treatment
Item
any previous treatment with a FLT-3 inhibitor
boolean
C0013227 (UMLS CUI-1)
CL414898 (UMLS CUI-2)
C1333568 (UMLS CUI-3)
CL414898 (UMLS CUI-2)
C1333568 (UMLS CUI-3)
HIV treatment
Item
requires current treatment for HIV with protease inhibitors
boolean
C0019693 (UMLS CUI-1)
Gastrointestinal ulceration or bleeding
Item
active GI ulceration or bleeding
boolean
C0237938 (UMLS CUI-1)
C0017181 (UMLS CUI-2)
C0017181 (UMLS CUI-2)
Other investigational drug
Item
use of an investigational drug that is not expected to be cleared by the start of CEP-701 treatment
boolean
C1516879 (UMLS CUI-1)